Tel: 561-316-3330
Email: mdnewsmagazine@infomeddnews.com
Home Blog Page 39

JACC Report Card Highlights Inequities in CV Care, Death Rates

As we commemorate Juneteenth 2024, JACC, the flagship journal of the American College of Cardiology, has published “Excess Cardiovascular Mortality Among Black Americans 2000-2022: A Report Card,” to highlight the persistent and tragic inequities in cardiovascular care and put in human terms the years of life lost to the Black community because of their higher cardiovascular disease death rates.

JACC Incoming Editor-in-Chief Harlan M. Krumholz, MD, SM, FACC, said, the goal of the report card is to promote accountability and catalyze action that finally addresses this national tragedy.

“Our study reveals that Black Americans, because of their higher cardiovascular mortality rates compared with White Americans, have suffered almost 800,000 excess deaths, which translates to about 24 million additional years of life lost between 2000 and 2022,” Krumholz, who is also senior author of the study and the Harold H. Hines, Jr. Professor of Medicine at Yale School of Medicine said. “This staggering figure highlights the critical need for systemic changes in addressing cardiovascular inequities.”

In an accompanying editorial, Jennifer H. Mieres, MD, FACC, chair of the ACC Diversity and Inclusion Committee and Senior Vice President, Center for Equity of Care, at Northwell Health in New Hyde Park, New York, said the report card serves as a reminder that all Americans have not benefited equally from significant advances made in the treatment and prevention of cardiovascular diseases.

“We are reminded of the stark reality that Black Americans continue to face significant disparities in cardiovascular outcomes,” Mieres said. “Bringing an equity lens to the redesign of CV health by addressing the social determinants of health and the systemic barriers that contribute to structural racism are critical for solving for cardiovascular health disparities and ensuring equity of care.”

Social determinants of health have a detrimental impact in creating barriers that prevent the most vulnerable Americans from receiving the cardiovascular care they need. The ACC has established multiple programs to address these inequities. The Internal Medicine Program introduces groups who have been historically underrepresented in cardiology to a career in cardiology by connecting them with the mentors, peer network and resources they need to understand career opportunities in the field and be better prepared to address the unique and diverse health care challenges their patients face.

The Clinical Trials Research (CTR) program is intended to increase the number of individuals historically underrepresented in cardiology who serve as leaders in cardiovascular clinical trials research to ensure diversity of thought, experience and perspective, and ensure that the evidence base includes data more closely reflecting the demographics of actual cardiovascular patients.

ColdVentures Unveils First-of-its-Kind, Class 1 FDA Medical Device ColdVest to Prevent Heat-Related Deaths

With annual heat-related deaths projected to increase 370 percent by 2050, rising temperatures and extreme heat events pose a significant threat to humans. As heat waves intensify, ColdVentures, a medical device company developing innovative new technologies to combat heat-related deaths, has unveiled ColdVest, a first-of-its-kind, Class 1 FDA portable emergency cooling device to protect people from heat-related brain or organ damage and death before emergency medical services arrive.

“Heat-related deaths have been increasing dramatically in recent years, with estimates ranging from tens of thousands to hundreds of thousands of incidents annually worldwide. 2023 alone set a heat death record in the United States. We need to look beyond      treatment methods like ice baths and adopt new technologies to save lives, as heat stroke is preventable in most cases,” said Tracie Wagman, ColdVentures Co-Founder and CEO. “ColdVest is the only portable emergency device available for heat stroke that does not require electricity or refrigeration. Given that people endured, on average, 86 days of health-threatening high temperatures last year globally, ColdVest has the potential to save thousands of lives around the globe each year.”

Heat stroke poses a particularly deadly threat to military personnel performing strenuous activities and wearing heavy gear in scorching environments; outdoor workers including construction crews, farmers and landscapers who are exposed to direct sunlight and high temperatures for long hours; firefighters battling blazes; and athletes training and competing in hot weather conditions. Heat stroke is especially dangerous for young athletes or those unaccustomed to extreme temperatures.

People suffering from heat stroke typically have 30 minutes before suffering permanent harm. In just under three minutes, ColdVest can reduce core body temperatures up to five degrees and stabilize an individual. Using patented endothermic cooling technology, ColdVest does not require electricity, refrigeration, ice or special storage. To use, add three liters of liquid to ColdVest’s integrated bladder, which then spreads throughout the vest to rapidly activate internal cooling chemicals. ColdVest is then placed over the torso of an individual for immediate relief. To learn more, visit coldvest.com.

Alveo’s Portable, Rapid Molecular Diagnostic Platform Proves Unshakable in Rigorous Ruggedness Tests

Alveo Technologies, Inc. (Alveo), a leader in molecular sensing and diagnostics with its proprietary technology platform, today announced the results of rigorous testing that demonstrate the ruggedness of its portable molecular testing platform. Whether it fell from a significant height, endured temperature and humidity extremes, or was subjected to jarring vibrations that mimic vehicle transportation of virtually any type — the device continued to complete tests and produce accurate results.

Alveo’s rapid molecular diagnostic platform has been designed to provide accurate, rapid test results at the point of need. The company tested its platform to demonstrate that it can perform reliably in harsh, real-world conditions, where markets, applications and use cases previously did not exist due to this unmet market need and requirement.

  • Specifically, the Alveo platform underwent the following tests:
    Environmental resilience: The device was placed in controlled chambers at 5 degrees Celsius and 40 degrees Celsius at up to 95% humidity for 24 hours.
    Movement and vibration: At a third-party facility, the platform was subjected to constant motion and vibration for nearly four hours (233 minutes and 34 seconds), simulating what the device would experience in the back of a moving delivery truck.
  • Drop testing: The device was dropped from up to 1 meter in height onto a hardwood board.
  • Cleaning: The analyzer was wiped down 100s of times with five different common disinfectants, including commercial bleach, isopropyl alcohol and hydrogen peroxide.

The results demonstrate that the Alveo platform can accurately perform tests in the field, under the most extreme of conditions. In the environmental resilience, drop, and cleaning tests, the device completed tests with 100% accuracy, and in the movement and vibration test, it also performed at 100% accuracy when the LED was facing up. When the LED was facing down during the vibration and movement test, it completed tests with 94% accuracy. The company is actively working on its next generation platform, enabling 360-degree capability with 100% accuracy.

“These tests thoroughly demonstrate our platform’s ability to provide consistent performance at the point of need, whether testing takes place in fields, on farms and in animal pens, remote locations, disaster zones, and beyond,” said Shaun Holt, CEO at Alveo. “Our rugged design and innovative molecular detection technology make it possible for healthcare providers, veterinarians, growers, and public health officials to obtain rapid, accurate results at the point of need, enabling them to take immediate action to treat and contain diseases, bacteria, fungi, and other contaminants. Alveo is leading the way by delivering a system that works in harsh environments where fast, easy testing without compromise is needed most. This study verifies that we can produce PCR-like results for a whole new set of applications, use cases, and a much broader user base than traditional molecular diagnostic methods.”

For more information on how the Alveo platform performed during ruggedness testing, read the full report: Built for Point of Need™ Detection: Ruggedness Testing of the Alveo Analyzer https://alveotechnologies.com/rugged.

VitaFlow Liberty ™ Granted EU CE-MDR Mark

VitaFlow Liberty

MicroPort® CardioFlow Medtech Corporation (CardioFlow) (Stock Code: 02160.HK) recently announced that its self-developed second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow LibertyTM Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow LibertyTM), has received EU CE-MDR certification. This certification highlights VitaFlow LibertyTM as a pioneering TAVI solution, that sets a new benchmark in transcatheter heart valve treatments.

With over 47 million patients globally[1] suffering from aortic valve stenosis and regurgitation, the prevalence rates of these conditions are on the rise due to an aging population. The TAVI solution provided by CardioFlow, which avoids open-heart surgery and offers various benefits like minimal trauma, quick recovery, and enhanced quality of life, is increasingly becoming a preferred choice for patients with aortic heart valve disease.

CardioFlow, one of the world’s leading innovative medical device companies, has entered the field of structural heart disease when the field was still at an early adoption phase. Originating and headquartered in Shanghai, China, CardioFlow was listed on the Hong Kong Stock Exchange on February 2021. The company has a diverse product pipeline resulting from independent and collaborative research, covering structural heart devices such as transcatheter aortic, mitral, and tricuspid valves, left atrial appendage occludes, and accessories. Leveraging its technological expertise and capacity for innovation, the company has successfully obtained approvals and launched several TAVI products globally, among which VitaFlow LibertyTM stands out as the world’s only electric retrievable transcatheter aortic valve system. The VitaFlowTM series TAVI solution along with its accessory – the AlwideTM series Balloon Catheter, has successfully covered nearly 700 core hospitals in 10 countries and regions, treating more than 10,000 patients with aortic valve disease worldwide.

The clinical data from VitaFlowTM series valves were revealed at PCR London Valves 2023, a leading global conference on structural heart diseases. These results highlight VitaFlowTM‘s exceptional long-term clinical performance aligning with international top-tier standards. The long-term results of VitaFlowTM in high surgical risk patients with severe aortic stenosis showed promising outcomes in all-cause mortality, cardiac mortality, and permanent pacemaker implantation rates for patients over seven years, compared to other similar studies. During the conference, Dr. Darren Mylotte from Galway University Hospitals, Ireland, commented on the excellent data, and introduced the advantages of VitaFlow LibertyTM in its one of a kind motorized delivery system. The system can assist the valve to position easily due to its flexibility and 360° range of motion when treating complex anatomical patients with severe angled aortic arch deformities. The valve can also be fully retrieved and repositioned when released to 75%, and provides up to 3 retrievable opportunities for each procedure, thereby further optimizing the implantation effect. Additionally, it can effectively ensure the stability of valve release, reduce valve displacement, and make the procedure more controllable.

Before launching into the EU market, VitaFlow LibertyTM conducted pre-market clinical implantations at Galway University Hospital in Ireland, Rigshospitalet (Copenhagen University Hospital) in Denmark, and St Thomas’ Hospital as well as Brighton & Sussex University Hospitals NHS Trust in the United Kingdom, and received very high appraisal from many well-known clinical professionals. Dr. Ole De Backer, a professor of interventional cardiology, who led the TAVI procedures at Rigshospitalet stated, “The overall release process of VitaFlow LibertyTM is notably stable, ensuring precise positioning. This stability is especially crucial in patients with a small left ventricles, where VitaFlow LibertyTM consistently achieves stable and precise deployment, fully demonstrating its distinct advantages. We look forward to its positive impact on a broader patient population following CE certification.” It has been reported that the European post-market clinical project will also be planned to start this year.

As part of CardioFlow’s global expansion roadmap, the company has also achieved significant milestones with CE application on three of its products, including the AlwideTM Plus Balloon Catheter, an essential accessory for aortic valve procedures, as well as the AnchorManTM Left Atrial Appendage Closure System and the AnchorManTM Left Atrial Appendage Access System, both developed by its subsidiary, CardioAdvent.

Jeff Lindstrom, President of CardioFlow, stated, “The certification of VitaFlow LibertyTM by the CE regulatory body under MDR, is a testament to CardioFlow’s world-class R&D, quality, and clinical capabilities. This recognition will expedite the global clinical adoption of the VitaFlowTM series along with other innovative products, advancing CardioFlow’s globalization strategy. This achievement also positions us to make a more substantial contributions to developments in the field of heart valve interventions, ultimately benefiting patients across the globe.”

Guoming Chen, Chairman of CardioFlow, commented, “Securing the EU CE-MDR marking for VitaFlow LibertyTM is not just a passport for the product’s entry into the European market, it also represents a significant milestone in CardioFlow’s history and global roadmap. This achievement will assist in diversifying the company’s sources of sales revenue and bolstering our overall competitiveness with a steadfast commitment to world-class product innovation.”

1. Frost & Sullivan’s statistics, 2021

 

Philips Zenition 90 Motorized receives FDA 510(k) Clearance

Zenition 90 Motorized

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of Philips Image Guided Therapy Mobile C-arm System 9000 – Zenition 90 Motorized, designed to help clinicians deliver high-quality care to more patients. Philips is partnering with its customers to improve productivity. The new mobile C-arm with expanded capabilities is designed to meet complex vascular needs, but also a range of clinical procedures such as cardiac interventions, pain management and urology. Philips will be showcasing its newly introduced mobile C-arm at the 2024 Society for Vascular Surgery Annual Meeting, June 19-22, in Chicago.

Increased control and efficiency with automated workflows

The Philips Zenition Image-Guided Therapy Mobile C-arm Systems bring together innovations in image capture and processing, ease-of-use, and versatility, many of which were pioneered on Philips’ highly successful image guided therapy platform Azurion. Motorized and impressively fast, the Zenition 90 Motorized is an intuitive C-arm that allowsclinicians to control it from the table-side with user-friendly controls and time-saving features – empowering the clinician with greater flexibility and independence. It delivers state-of-the-art image quality for the most challenging procedures and is designed to meet complex procedural needs. The system allows greater clinical efficiency thanks to its automated workflows, the image controls via the Touch Screen Module and the advanced software solutions.

“During complex procedures, it’s vital to be able to rely on surgical imaging systems. As clinicians navigate their way through challenging anatomy, the priority is to quickly visualize small anatomical details while limiting X-ray dose,” said Mark Stoffels, Business Leader Philips Image Guided Therapy Systems. “The new Zenition 90 Motorized empowers medical teams to confidently perform a wide range of interventions while achieving the best possible outcome for their patients.”

In independent hands-on usability studies of clinicians from the US and EU with the Zenition 90 Motorized in simulated environments; 100% of users said that with the Table Side Operator, they have complete control over C-arm movements [2] and 97% report that workflow features such as Automatic Vascular Outlining will help save time during procedures [3].

As part of its commitment to sustainability and providing customers with responsible choices, Philips leveraged its EcoDesign process for the Zenition 90 Motorized to improve product life by 25% and power efficiency by 13% [4].

Philips latest image guided therapy mobile C-arm system is also available in a non-motorized configuration.

Neuromod’s FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus

Lenire Device
Tinnitus patient using Lenire tinnitus treatment device

Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government, making the Lenire tinnitus device a treatment option for the 2.9 million US Veterans living with tinnitus5 through the Department of Veterans Affairs (VA).

The General Services Administration FSS Contract will also make Lenire an option for patients receiving care from the Department of Defense (DoD), Bureau of Prisons, Indian Health Services, and Public Health Services.

The Lenire Device is the first bimodal neuromodulation device to receive a Federal Supply Schedule (FSS) Contract. It can be prescribed when appropriate by a trained healthcare clinician for the treatment of tinnitus.

General Services Administration’s decision to award the FSS contract was based on Neuromod Devices’ clinical trial success, commercial sales practices, financial performance, and additional clinical capability factors.

Tinnitus, which is commonly known as “ringing in the ears,” is a complex neurological condition afflicting an estimated ten percent of all adults.4 It causes a perception of sound when there is no external source. If left untreated, tinnitus severity can have a significant impact on a person’s quality of life.

Tinnitus has been the number one service-connected disability compensated for by the VA since 1955. More than 2.9 million veterans received more than $5 billion in compensation in 2023.5 Sixty-three percent of all auditory Veteran Compensation Claims were for tinnitus.5

“Tinnitus is the number one service-connected disability,” said Eric Timm, Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations.

“The number of veterans with tinnitus is growing at a double-digit rate annually. Neuromod’s FSS Contract ensures that current and future veterans have access to clinically proven tinnitus treatment technology. Everyone at Neuromod is privileged to be serving our veterans by doing our part for tinnitus care.”

Lenire’s bimodal neuromodulation works by pairing specially designed tones heard through wireless headphones with mild electrical pulses that stimulate the tongue through a component called the Tonguetip®.

In March 2023, Lenire became the first tinnitus treatment device to be awarded FDA Approval through the De Novo framework. FDA Approval was granted based on the success of Lenire’s controlled large-scale clinical trial, TENT-A3.

That trial confirmed Lenire was clinically superior to sound-only stimulation. 70.5% patients with moderate or worse tinnitus who did not report clinically significant improvement in their tinnitus from six weeks of sound-only, reported clinically significant tinnitus improvement following six weeks of treatment with Lenire.3 The majority of patients with moderate or worse tinnitus who benefitted from six weeks of sound-only stimulation experienced additional benefit from a further six weeks of treatment with Lenire.3, 6

Nearly 89 percent of clinical trial participants would recommend Lenire to treat tinnitus.6

References 

  1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
  2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)
  3. Neuromod Devices Ltd., Lenire (CR-201) Clinician’s Manual, (2023)
  4. https://www.nidcd.nih.gov/health/tinnitus
  5. US VA Benefits Report Fiscal Year 2023: https://www.benefits.va.gov/REPORTS/abr/
  6. TENT-A3 trial data in preparation for publication: https://clinicaltrials.gov/study/NCT05227365?intr=lenire&rank=1

Surgical Suction Instruments Market to Hit USD 503 Million by 2029, Driven by 6.1% CAGR

The global surgical suction instruments market is projected to reach USD 503 million by 2029, growing at a CAGR of 6.1% from USD 375 million in 2024, driven by increasing adoption of minimally invasive surgery and rising prevalence of chronic diseases. Key players such as Cardinal Health, Inc., Stryker Corporation, and Medtronic are prominent in the market, with Cardinal Health emphasizing patient outcomes and medication adherence, Stryker focusing on orthopedics and neurotechnology, and Medtronic offering a broad range of surgical tools and equipment for various medical procedures.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=129636225

Browse in-depth TOC on “Surgical Suction Instruments Market“

390 – Tables
300 – Figures
400 – Pages

Surge in Surgical Procedures Fuels Demand for Suction Instruments

The escalating number of surgeries globally serves as a prime catalyst for the surgical suction instruments market. With surgeries on the rise, the demand for these vital tools intensifies, ensuring optimal surgical conditions, minimizing complications, and enhancing patient outcomes. This upward trajectory is anticipated to persist, driving sustained market growth.

Balancing Innovation with Risks of Surgical Suction Instruments

While surgical suction instruments play a crucial role in medical procedures, complications such as unintended tissue injury and infection pose significant challenges. Improper usage or excessive suction power can lead to adverse outcomes, necessitating meticulous technique and careful suction level selection, especially in laparoscopic procedures. Addressing these risks is vital to ensuring market stability and growth.

Sustainable Solutions: The Rise of Biodegradable Materials in Surgical Instruments

The growing demand for eco-friendly practices in healthcare settings presents a promising opportunity for the adoption of biodegradable materials in surgical instruments. Unlike traditional plastics, biodegradable alternatives offer a sustainable option, decomposing naturally after disposal and reducing environmental impact. This trend aligns with the industry’s focus on sustainability, paving the way for market expansion and innovation.

Navigating Complexities in Cleaning and Disinfection of Advanced Instruments

The cleaning and disinfection of advanced surgical suction instruments pose a formidable challenge due to intricate designs and delicate components. Thorough cleaning is essential to maintain functionality and prevent damage, yet harsh chemicals and aggressive scrubbing techniques can compromise instrument integrity. Addressing these complexities is crucial for sustaining market growth amidst evolving technological advancements.

Competitive Landscape and Market Pressures in the Surgical Instruments Industry

The surgical suction instruments market witnesses increasing competition as new entrants join and established players vie for market share. This competition drives down prices, exerting pressure on medtech businesses to balance profitability with competitiveness. Consolidation within the industry and shifts in healthcare policies further impact market dynamics, requiring players to adapt pricing strategies to navigate regulatory changes and reimbursement rates.

Yankauer Suction Tubes Forecasted to Lead Surgical Suction Instruments Market Growth

Within the surgical suction instruments industry, the yankauer suction tube segment is anticipated to exhibit the highest CAGR from 2024 to 2029. This segment encompasses various types, including retractors, yankauer suction tubes, poole suction tubes, frazier suction tips, and others. Yankauer tubes, distinguished by their cost-effectiveness and durability, particularly stand out among specialized disposable suction tips. Crafted from premium medical-grade materials like stainless steel, yankauer tubes offer reusability after proper sterilization, thus propelling segment growth.

Surge in General Surgery Applications to Drive Market Expansion

The general surgery segment is poised to witness the highest CAGR in the surgical suction instruments industry from 2024 to 2029. Suction instruments play a pivotal role in removing blood, fluids, and debris from surgical sites, enhancing visualization and facilitating precise dissection while minimizing tissue damage. Moreover, during procedures involving electrocautery, suction aids in clearing smoke, improving visibility, and mitigating the risk of smoke inhalation for both surgical teams and patients, thereby fostering segment growth.

Hospitals and Clinics Segment to Spearhead Market Advancement

The hospital and clinics segment is forecasted to demonstrate the highest CAGR in the surgical suction instruments industry from 2024 to 2029. This surge in demand is propelled by the critical role these institutions play in meeting escalating surgical needs, driving the necessity for essential tools like surgical suction instruments. Vital for enhancing surgical outcomes, patient satisfaction, and infection control, the demand for these instruments is expected to persist, underpinning segment growth in the foreseeable future.

North America Emerges as Key Driver of Surgical Suction Instruments Market

North America emerges as a dominant force in the global surgical suction instruments industry, boasting the largest CAGR among regions during the forecast period. This growth is attributed to various factors, including governmental initiatives promoting health awareness and subsidizing treatments, thereby stimulating market expansion. The region experiences a significant uptick in demand for surgical suction instruments, driven by evolving patient needs and dynamic shifts in the healthcare landscape.

Key Developments Shape Surgical Suction Instruments Industry Landscape

1.  Olympus Corporation Enhances GI Endo Therapy Portfolio Through Acquisition

In January 2024, Olympus Corporation expanded its capabilities by acquiring Taewoong Medical Co., Ltd., a Korea-based medical device manufacturer. This strategic move bolsters Olympus’ GI Endo Therapy product portfolio, aiming to enhance patient outcomes through comprehensive solutions and elevate the standard of care in gastrointestinal endoscopy.

2.  Stryker Broadens Aneurysm Treatment Solutions with Cerus Endovascular Acquisition

May 2023 witnessed Stryker’s acquisition of Cerus Endovascular Ltd. (UK), a medical device company specializing in neurointerventional devices. Cerus Endovascular’s innovative products complement Stryker’s existing portfolio, enriching the company’s offerings in aneurysm treatment solutions and reinforcing its commitment to advancing neurointerventional care.

3.  Cardinal Health, Inc. Partners with Kinaxis to Enhance Supply Chain Agility

In September 2022, Cardinal Health, Inc. announced a strategic partnership with Kinaxis (Canada) to enhance the Kinaxis RapidResponse Platform for supply chain agility and medical product visibility. This collaboration underscores Cardinal Health’s commitment to optimizing supply chain operations, ensuring efficient distribution of surgical suction instruments, and meeting evolving healthcare demands.

4.  Medtronic and American Society for Gastrointestinal Endoscopy Expand Health Equity Assistance Program

July 2022 marked the expansion of the Health Equity Assistance Program by Medtronic and the American Society for Gastrointestinal Endoscopy, supported by Amazon Web Services. As part of this initiative, the first installation of donated GI Genius intelligent endoscopy modules was completed, aiming to improve access to colon cancer screening and advance healthcare equity.

More information here.

Gyrolab Generic Anti-AAV Kit to Support Gene Therapy Development | Introduced by Gyros Protein Technologies

Gyrolab Generic Anti-AAV Kit

Gyros Protein Technologies AB, a pioneer in automated nanoliter-scale immunoassays and leading provider of peptide synthesizers today announced the introduction of its Gyrolab® Generic Anti-Adeno Associated Virus (AAV) Kit. The new ready-to-use kit facilitates the qualitative assessment of pre-existing binding antibodies against AAV vectors, enabling screening in pre-clinical and clinical settings. The Gyrolab Generic Anti-AAV Kit supports the identification of pre-existing immunity that may interfere with the efficacy of AAV-based gene therapy delivery.

The ready-to-use kit, designed to detect total binding anti-capsid antibodies against the most commonly used AAV serotypes, is the first of its kind on the market for assessing pre-existing anti-AAV antibodies, streamlining the screening process by eliminating the need for serotype-specific assay development. Compared to other methods currently used for detecting pre-existing binding antibodies, the kit removes the need for capsid labelling, reducing variability and ensuring reproducible data whilst requiring small quantities of viral capsids, preserving precious drug volumes.

The kit is optimized for use on all Gyrolab systems and expands the utility of the Gyrolab platform into the bioanalytical field of AAV-based gene therapies. Automation with Gyrolab systems reduces variability due to manual pipetting and speeds up workflows by reducing assay development time and generating results within 90 minutes, helping to accelerate the development of novel gene therapies.

Mark Vossenaar, General Manager, Biopharmaceutical Development Division, Gyros Protein Technologies, commented: “The new Gyrolab Generic Anti-AAV Kit is tailored to meet customer needs in the bioanalysis of AAV-based gene therapeutics, focusing on efficiency, resource, and time-savings. This innovative addition expands our portfolio of ready-to-use kits, providing a rapid, cost-effective solution for the detection of total binding antibodies without necessitating serotype-specific assay development or extensive optimization. Gyrolab Generic Anti-AAV Kit provides our customers with convenience whilst ensuring robust and reliable data. This allows for more informed decisions regarding individual stratification following preexisting anti-AAV antibody screening.”

Venus Medtech VenusP-Valve Completed First Implantation in IDE Pivotal Clinical Study in U.S.

Venus Medtech VenusP-Valve

Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that its in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, VenusP-Valve, has completed its first implantation in the PROTEUS IDE Pivotal Clinical Study at the University of Virginia School of Medicine. This momentous procedure was performed by a multidisciplinary team coordinated by Prof. Scott Lim and Prof. Michael Hainstock of the center.

This marks a significant advancement in the international progress of VenusP-Valve and represents another milestone following its CE MDR approval in April 2022.

The VenusP-Valve PROTEUS STUDY, abbreviated from Evaluation of the PerfoRmance Of The VEnUsP-Valve System in Patients with Native Right Ventricular Outflow Tract (RVOT) Dysfunction, is a prospective multi-center non-randomized interventional study in patients with RVOT disorders comorbid with moderate or greater pulmonary regurgitation. With a target enrollment of 60 subjects, data from this trial will support VenusP-Valve’s registration with the U.S. FDA and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

In late 2023, the VenusP-Valve PROTEUS trial received coverage approval from the U.S. Centers for Medicare & Medicaid Services (CMS). With this endorsement, all eligible beneficiaries can be reimbursed for VenusP-Valve treatment in the study.

Following its first clinical implantation in 2013, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, etc., and has been approved in more than fifty countries, including China, Germany, France, the United Kingdom, Italy, Spain, Canada, and Australia, with its implantation seeing continuous growth in new hospitals and centers.

“We’re honored to be part of the VenusP-Valve PROTEUS trial,” said Prof. Scott Lim after the procedure. “We’ve just completed the first patient enrollment in that trial using the VenusP-Valve. This worked quite well, and it really represents a possibility of better ways of treating patients with significant pulmonary valve disease.”

“That went really smoothly in this teenage patient with free pulmonary insufficiency”, commented Prof. Michael Hainstock. “I’m very happy with the valve deployment and position. This (VenusP-Valve) is another option for our patients to treat pulmonary valve disease.”

“The successful first implantation in the VenusP-Valve PROTEUS study in the U.S. represents an important milestone for Venus Medtech in this crucial market,” said Lim Hou-Sen, General Manager and CEO of Venus Medtech. “The device has already received compassionate use approval from the FDA in a number of cases, underscoring its unique clinical advantages and high regulatory recognition. Moving forward, we will redouble efforts to advance VenusP-Valve’s clinical progress, speeding up its approval process with both the FDA and Japan’s PMDA.”

About VenusP-Valve: As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

The long-term safety and efficacy of VenusP-Valve has been backed by impressive clinical data. According to three-year follow-up results of the clinical trial in Europe, the product demonstrated 100% procedural success and 0% all-cause mortality and reoperation among 81 patients who underwent TPVR. Right ventricular function improved significantly. Only one patient had severe pulmonary regurgitation.

Pfizer Reports | ELREXFIO ™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma

Pfizer Inc. (NYSE: PFE) today announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). The study demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial.

These data from MagnetisMM-3 will be presented during a poster session (#932) at the European Hematology Association (EHA) Hybrid Congress in Madrid, Spain, from June 13-16. Additional presentations at EHA 2024 will highlight ELREXFIO data across the comprehensive MagnetisMM clinical trial program.

“These compelling overall survival data support the clinical benefit ELREXFIO has already demonstrated and its potential to be a transformative treatment option for people with multiple myeloma,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “The latest results from MagnetisMM-3 reinforce the very promising efficacy observed with ELREXFIO in a relapsed or refractory setting, with deep and durable responses and although definitive conclusions cannot be drawn across studies, the longest reported median progression-free survival among B-cell maturation antigen bispecific antibodies.”

After more than two years of follow-up in the MagnetisMM-3 trial, the overall response rate (ORR) for patients on ELREXFIO was 61.0% (37.4% ≥complete response rate (CRR)), with responses deepening over time, and the median duration of response (DOR) was not reached. At two years, the estimated DOR rate was 66.9% (95% CI: 54.4, 76.7) for all responders, and 87.9% (95% CI: 73.1, 94.8) for patients with CR or better response. Median progression-free survival (PFS) was 17.2 months (95% CI: 9.8 months-NE). For patients with CR or better response, the median PFS was not reached, and at two years, the estimated PFS rate was 90.6% (95% CI: 76.9, 96.4).

“People with relapsed or refractory multiple myeloma often have limited therapeutic options as their disease progresses due to treatment resistance, resulting in increasingly shorter remission and duration of response,” said MagnetisMM-3 clinical trial investigator Mohamad Mohty, M.D., Ph.D., Professor of Hematology and Head of the Hematology and Cellular Therapy Department at the Saint-Antoine Hospital and Sorbonne University, Paris, France. “These impactful overall survival data are particularly encouraging given the very advanced patient population with characteristics associated with poorer outcomes.”

The safety and tolerability of ELREXFIO in MagnetisMM-3 were consistent with what have been previously observed. Five patients (4.1%) experienced secondary primary malignancies (SPMs), all cases being squamous cell carcinoma of the skin, consistent with SPMs often observed in patients with multiple myeloma (MM), while no hematological SPMs were reported. Due to the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), patients should be monitored for signs and symptoms for 48 hours after administration of each of the two step-up doses within the ELREXFIO dosing schedule and instructed to remain in proximity of a healthcare facility. In the EU, precautionary hospitalization is not required. Patients are not required to stay near a healthcare facility for the 76 mg first treatment dose.

Based on results of the MagnetisMM-3 trial, ELREXFIO received accelerated approval in August 2023 from the U.S. Food and Drug Administration for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial. In December 2023, the European Commission granted conditional marketing authorization for ELREXFIO for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. ELREXFIO has also received approval in Switzerland, Brazil and Canada under Project Orbis, a framework for the concurrent submission and review of oncology drugs among international partners to potentially expedite approvals. Two other countries (Australia and Singapore) are participating in Project Orbis. The Medicines and Healthcare products Regulatory Agency (MHRA) granted ELREXFIO authorization for Great Britain for RRMM.

Pfizer’s comprehensive ongoing MagnetisMM clinical development program is investigating the use of elranatamab across the entire spectrum of patients with MM, from RRMM to newly diagnosed MM. Ongoing registrational-intent trials are comparing elranatamab to current standards of care both as monotherapy and in combination with standard or novel therapies. These include MagnetisMM-4 investigating elranatamab treatment with other anti-cancer therapies, MagnetisMM-5 in the double-class exposed setting, MagnetisMM-6 in newly diagnosed patients who are ineligible for stem cell transplant, MagnetisMM-7 in newly diagnosed patients after transplant, and MagnetisMM-32 in patients with prior anti-CD38-directed therapy.

About MagnetisMM-3

MagnetisMM-3 is an open-label, multicenter, non-randomized Phase 2 study of ELREXFIO monotherapy in participants with multiple myeloma who are refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-cluster of differentiation 38 antibody. The study enrolled two cohorts of participants: one with and one without prior treatment with a B-cell maturation antigen-directed antibody-drug conjugate or chimeric antigen receptor T-cell therapy. Participants received subcutaneous ELREXFIO as two step-up priming doses followed by a weekly 76 mg injection. The primary endpoint is objective response rate as assessed by Blinded Independent Central Review (BICR). Key secondary endpoints include duration of response, progression-free survival, minimal residual disease negativity rate, overall survival, and safety. For more information about the trial, visit www.clinicaltrials.gov (NCT04649359).

About Multiple Myeloma

Multiple myeloma (MM) is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection.1 MM is the second most common type of blood cancer, with over 50,000 new cases diagnosed annually in Europe and over 187,000 new cases diagnosed globally each year.2,3 About 40% of those diagnosed with MM won’t survive beyond five years,4 and most will receive 4 or more lines of therapy due to relapse.5 While disease trajectory varies for each person, relapses are nearly inevitable.6 The goal of therapy for people with relapsing or refractory MM is to achieve disease control with acceptable toxicity and improved quality of life.7

About ELREXFIO (elranatamab-bcmm)

ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-cluster of differentiation (CD)3-directed bispecific antibody immunotherapy that binds to BCMA on myeloma cells and CD3 on T cells, activating the T cells to kill myeloma cells.

U.S. INDICATION

ELREXFIO may cause side effects that are serious, life-threatening, or can lead to death, including cytokine release syndrome (CRS) and neurologic problems. CRS is common during treatment with ELREXFIO.

Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS or neurologic problems, including:

  • fever of 100.4°F (38°C) or higher
  • trouble breathing
  • chills
  • dizziness or light-headedness
  • fast heartbeat
  • headache
  • increased liver enzymes in your blood
  • agitation, trouble staying awake, confusion or disorientation, or seeing or hearing things that are not real (hallucinations)
  • trouble speaking, thinking, remembering things, paying attention, or understanding things
  • problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
  • numbness and tingling (feeling like “pins and needles”)
  • burning, throbbing, or stabbing pain
  • changes in your handwriting

Due to the risk of CRS, you will receive ELREXFIO on a “step-up” dosing schedule and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO.

  • For your first dose, you will receive a smaller “step-up” dose of ELREXFIO on day 1
  • For your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on day 4 of treatment
  • For your third dose, you will receive the first “treatment” dose of ELREXFIO, which is usually given on day 8

If your dose of ELREXFIO is delayed for any reason, you may need to repeat step-up dosing. Before each dose of ELREXFIO you receive during the step-up dosing schedule, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.

ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists signs and symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the signs and symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Before taking ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection
  • are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby. Females who are able to become pregnant should do a pregnancy test before starting treatment with ELREXFIO and should use effective birth control during treatment and for four months after your last dose of ELREXFIO. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO
  • are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for four months after your last dose of ELREXFIO

Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

Do not drive, operate heavy or potentially dangerous machinery, or do other dangerous activities during treatment with ELREXFIO:

  • for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the “step-up dosing schedule” and your first full treatment dose, and
  • at any time during treatment with ELREXFIO if you develop any new neurologic symptoms, such as dizziness, confusion, shaking (tremors), sleepiness, or any other symptom that impairs consciousness, until the symptoms go away

Infections: Upper respiratory tract infection and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.

  • Your healthcare provider may prescribe medications for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO
  • Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including: fever of 100.4°F (38°C) or higher, chills, cough, shortness of breath, chest pain, sore throat, pain during urination, or feeling weak or generally unwell
  • People with active infections should not start ELREXFIO

Decreased white blood cell counts: Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. A fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.

Liver problems: ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of a liver problem, including:

  • tiredness
  • loss of appetite
  • pain in your right upper stomach-area
  • dark urine
  • yellowing of your skin or the white part of your eyes

The most common side effects of ELREXFIO include:

  • tiredness
  • injection site reaction, such as redness, itching, pain, bruising, rash, swelling, and tenderness
  • diarrhea
  • muscle and bone pain
  • decreased appetite
  • rash
  • cough
  • nausea
  • fever

The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.

Your healthcare provider may temporarily or permanently stop ELREXFIO if you have any of the side effects listed and they are severe. These are not all of the possible side effects of ELREXFIO.

Call your healthcare provider for medical advice about side effects. You may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088.

What is ELREXFIO?

ELREXFIO is a prescription medication used to treat adults with multiple myeloma who:

  • have already received at least 4 treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, to treat their multiple myeloma, and
  • their cancer has come back or did not respond to prior treatment

ELREXFIO was approved based on patient responses and durability of response. There are ongoing studies to confirm its clinical benefit. It is not known if ELREXFIO is safe and effective in children.

Please read full Prescribing Information, including BOXED WARNING, for ELREXFIO.

References

1 Multiple Myeloma Research Foundation (MMRF). What is Multiple Myeloma? Available from: https://themmrf.org/multiple-myeloma/ [Last accessed: April 2024].
2 Myeloma Patients Europe. Myeloma A Patients Guide; Updated May 2022. Available from: https://www.mpeurope.org/wp-content/uploads/2023/01/Myeloma-Patients-Guide.pdf [Last accessed: April 2024].
3 World Health Organization. Globocan 2020: Multiple Myeloma. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf [Last accessed: April 2024].
4 National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer Stat Facts: Myeloma. Available from: https://seer.cancer.gov/statfacts/html/mulmy.html [Last accessed: April 2024].
5 Mikhael, J, Ismaila N, Cheung M, et al. Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. J Clin Oncol. 2019;37(14):1228–1263.
6 Dimopoulos MA, Richardson P, Lonial S. Treatment options for patients with heavily pretreated relapsed and refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2022;22(7):460–473. doi:10.1016/j.clml.2022.01.011
7 Bazarbachi AH, Al Hamed R, Malard F, et al. Relapsed refractory multiple myeloma: a comprehensive overview. Leukemia. 2019;33(10):2343–2357.

1...383940...923Page 39 of 923

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device news and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York
United States
Phone Number: 1.561.316.3330