FX Solutions Receives FDA 510k Clearances for Glenoid Baseplate With a Central Screw and 32mm Glenosphere and Humeral Cups

March 2, 2020

The Glenoid Baseplate includes a Central Screw that has (7) different central screw size length options ranging from 8mm to 20mm in 2mm increments. This provides an alternative to the glenoid baseplate having a central post and post extensions that FX currently has available to the US market.

FX Solutions notes the addition of the glenoid baseplate with a central screw allows surgeons perioperative options to address a variety of deficiencies and can now accommodate an even larger patient population and surgeon’s needs.

The 32mm Glenosphere and Humeral Cups further expand the offerings that FX has available to the US market, which includes the existing sizes of 36mm and 40mm. With the 32mm components added to the FX portfolio, surgeons may be able to address more diverse patient needs.

“These are significant achievements and additions for our portfolio. There is a constant need and request for exactly these types of implants. They complement what we already have and, even more so, allows us to further compete in an extremely competitive market,” said Baptiste Martin, CEO of FX Shoulder USA. “These additions continue our adventure…” he continued to say.

To see the entire FX portfolio, you can visit their exhibit booth at AAOS in Orlando from March 25-27, 2020.

Interim Efficacy Data from eCoin Pivotal Trial Reported

March 2, 2020

The prospective, multi-center, single-arm study of the safety and effectiveness of the eCoin peripheral neurostimulator showed clinically significant improvements. The eCoin Pivotal Trial study, intended to support the Food and Drug Administration (FDA) approval of the eCoin device, enrolled 133 subjects with urgency urinary incontinence. All available data was presented and the protocol did not include a trial of the therapy prior to eCoin implantation.

Data Highlights¹

Clinically significant improvements at 6 months in urgency urinary incontinence (UUI)
- 71% of patients reported a greater than or equal to 50% improvement in UUI
- 46% of patients reported a greater than or equal to 75% improvement in UUI
- 25% of patients reported a 100% improvement in UUI
70% median percent change from baseline in UUI as measured in episodes per day
34% mean improvement in quality of life and 34% reduction in symptom bother on the OABq
Infection rate of 2.3% with no other significant adverse events

Scott A. MacDiarmid, MD, an investigator in the trial, commented, “We are extremely encouraged by this early data and I continue to believe in the paradigm-shifting potential of eCoin. Despite the extremely high prevalence of OAB symptoms, many of my patients find current therapies as suboptimal and intolerable. We are overdue for a novel therapy that is well-tolerated, reasonably priced, efficacious with minimal maintenance and most importantly appealing to patients, and I believe eCoin is that therapy.”

Jeff Greiner, Chief Executive Officer of Valencia, stated, “We were excited to have Dr. Rogers present interim efficacy data from our pivotal trial at SUFU 2020. We continue to believe that upon trial completion and regulatory review, the simplicity and effectiveness of eCoin will allow Valencia to significantly broaden the addressable OAB market beyond what has been captured by sacral neuromodulation and other suboptimal therapy alternatives.”

Valencia’s pivotal study is evaluating the use of its eCoin implantable tibial neurostimulator for the treatment of overactive bladder syndrome (OAB) in patients with urgency urinary incontinence. The study is a prospective, multicenter, single-arm trial to evaluate the safety and effectiveness of tibial nerve stimulation with eCoin in 133 participants. Implanted under local anesthetic in approximately 20 minutes, the eCoin provides automated therapy and eliminates compliance-related burdens to patients. The study is designed to evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 48 weeks of eCoin therapy. Results from the trial will support Valencia’s pre-market approval application to the U.S. Food and Drug Administration upon completion.

Reference

¹ Data representative of patient-reported outcomes of 119 intent-to-treat (ITT) patients

Other clinical trial news can be found here.

Acquisition of Vigilenz Completed Reports Bactiguard

March 2, 2020

Acquisition of Vigilenz was announced on February 4, 2020.

All conditions precedent have been fulfilled and the first part of the total consideration, consisting of a cash payment of USD 4.5 million, has been paid. The remaining part of the consideration, 241 512 new class B-shares in Bactiguard, is subject to approval by the annual general meeting of shareholders in Bactiguard on 28 April 2020.

The cash portion has been financed through bank facilities provided by Skandinaviska Enskilda Banken (SEB), with a term of three years. At the same time, the term of Bactiguard’s current bank facility with SEB has been extended by the same tenor.

The Bactiguard Board of Directors has approved the transaction and shareholders including Christian Kinch, Thomas von Koch, Jan Ståhlberg, The Fourth Swedish National Pension Fund (AP4) and Nordea Investment Funds, together representing approximately 66 percent of the capital and 84 percent of the votes in Bactiguard have declared that they will support the issuance of new class B-shares at the AGM.

The newly acquired companies will be consolidated in Bactiguard’s financial accounts from March 2020. At the same time, the integration of the companies has been initiated, which means, among other things, that the product portfolios will be sold through both companies’ distribution networks.

Monteris Medical Founders to Receive Pioneer in Technology Award

March 2, 2020

Torchia and Tyc, both from Winnipeg, Manitoba, founded Monteris Medical in 1999 with the sole focus of helping patients who suffer from neurological diseases.

The revolutionary technology they developed – the minimally invasive NeuroBlate System, an MRI-guided, robotically controlled laser ablation surgical device – has been used in nearly 3,000 patients and in more than 80 institutions in the U.S. and Canada to ablate primary brain tumors, metastatic brain tumors, radiation effect and epileptic foci.

The SBMT presents this award to “the trailblazing companies and their CEOs/presidents who have facilitated the development of pioneering technologies through interdisciplinary approaches that have impacted diagnostics, treatment, and healthcare delivery in unprecedented ways.”

Torchia, who currently serves as vice-provost (teaching and learning) at the University of Manitoba in Winnipeg, said the idea for the technology came after a brain biopsy surgery he attended with a neurosurgeon. “I thought at that moment how beneficial it could be to the patient to slide a heat source down the small biopsy tract and affect some kind of change in the tumor,” said Torchia. Torchia and Tyc then began developing concepts and prototypes for laser technology use in the brain for primary tumors, using magnetic resonance imaging (MRI) as a way to monitor the heat.

Tyc, vice president of technology and advanced development at Monteris Medical, said the recognition was gratifying. “We knew then that there was tremendous potential in developing this technology,” commented Tyc. “The minimally invasive approach to the surgery and subsequent short recoveries change the game for patients that otherwise would undergo an open craniotomy or have no other option. Now, we’re looking at the technology’s next phase of development to offer hope to even more people.”

Tyc and Torchia will receive the award at the 17th Annual “Gathering for Cure” Black Tie Awards Gala of Brain Mapping Foundation, March 21 in Los Angeles.

Completion of Study Enrolment of Implandata’s Extraocular Eye Pressure Sensor for Continual Glaucoma Monitoring

March 2, 2020

Eye Pressure Sensor: While Implandata’s already CE marked EYEMATE-IO intraocular sensor implant is intended for use at glaucoma patients undergoing cataract surgery, the EYEMATE-SC device allows implantation at glaucoma patients not indicated for cataract surgery yet, thus complementing Implandata’s product offering and expanding the indication of use of the EYEMATE-system.

Prof. Dr. med Kaweh Mansouri, Consultant Ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland and CMO of Implandata comments: “We are pleased to have completed enrolment of this important study and having excellent outcomes so far in all patients, some of them having had the SC sensor for more than a year. Both safety and performance of the device have exceeded our expectations and we are looking forward to the forthcoming interim results.”

Study centers of the ARGOS-SC01 clinical study are the Eye Sulzbach at Knappschaft Hospital Saar/Germany, the Ophthalmic Clinic of Ruhr-University Bochum/Germany, the Department of Ophthalmology at University Mainz/Germany the Eye Department of LMU Medical School Munich/Germany and Montchoisi Clinique Lausanne/Switzerland. The study is closely supervised by an independent Data Safety Monitoring Board, chaired by Prof. emeritus Günter Krieglstein, who was the former Director of Department of Ophthalmology of Medical University Cologne/Germany and a worldwide renowned glaucoma expert.

Intraocular pressure monitoring is a considerable challenge for glaucoma patients and their ophthalmologists. Current IOP measurement methods require in-office procedures, to be performed by trained medical staff. However, these measurements are obtained just a few times a year, although it is known that the eye pressure is highly dynamic and influenced by many parameter and thus changing throughout the day.

In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE system provides actionable IOP measurements throughout 24 hours and outside the ophthalmologists office, enhancing treatment options and contributing to less progressing vision loss in glaucoma patients.

Robert N. Weinreb, M.D., Chair & Distinguished Professor of Ophthalmology and Director of the Shiley Eye Institute of University California San Diego/USA and Chair of Implandata’s Scientific Advisory Board predicts: “Continual measurement of intraocular pressure via the EYEMATE system will transform and individualize the management of glaucoma. In addition, it will enable improved adherence with medication and provide deeper insight about glaucoma.”

As the EYEMATE system provides direct feedback to the patient in a home setting – information previously unavailable to the patient – therapy adherence is expected to be improved, as it was already observed in earlier studies. Additionally, EYEMATE’s remote patient care capabilities will result in more efficient disease management, as number of office visits may be reduced for a considerable number of patients, while the eye doctor attains more and better information about the patient’s specific situation.

Other clinical trial news items can be found here.

Kitakyushu General Hospital Completes First Surgical Procedures with the Senhance Surgical System

February 28, 2020

Anthony Fernando, President and CEO at TransEnterix notes, “It is gratifying to see system installation, clinical training, Senhance program launch and first clinical cases completed within three weeks from signing of the agreement at Kitakyushu General Hospital and showcases the hospital’s commitment to integrating Senhance into their minimally invasive surgery program.” He added, “We look forward to continuing our clinical partnership with the Kitakyushu General Hospital team.”

Kitakyushu General Hospital is a prestigious institution and is recognized as one of the major hospitals in Kitakyushu. It offers both advanced and emergency medical care and is a core part of the Kitakyushu Hospital Group. It is a 360-bed facility that contains a critical care center and is the only general hospital in the Kitakyushu Hospital Group.

“We are pleased to bring this new minimally invasive surgery platform to our patients,” said Dr. Nagata. “Our Kitakyushu surgical team was able to easily and rapidly integrate the Senhance System program, progressing smoothly from installation, through staff training, to performing our first cases in a matter of weeks. The clinical partnership and comprehensive support from TransEnterix allowed us to efficiently launch this new program to our community.”

The Senhance^®System is the first and only digital laparoscopic surgical platform designed to maintain laparoscopic MIS standards while providing digital benefits such as haptic feedback, robotic precision, comfortable ergonomics, advanced instrumentation including, 3 mm microlaparoscopic instruments, eye-sensing camera control, and reusable standard instruments to help maintain per-procedure costs similar to traditional laparoscopy. It is the first new abdominal robotic surgery platform to receive FDA clearance since 2000 and is approved for use in Japan with broad reimbursement. The Senhance Surgical System was approved for use by the Japanese Ministry of Health, Labor and Welfare (MHLW) in 2019, and has the broadest procedural reimbursement of any abdominal robotic surgery platform in Japan, which applies to 98 benign and malignant laparoscopic procedures across general, colorectal, gynecologic, pediatric and urologic surgeries at reimbursement rates equivalent to traditional laparoscopy in Category A1.

CorTechs Labs Presents Findings on the Creation of Machine Learning Models to Aid Early, Accurate Diagnosis of MS at ACTRIMS 2020

February 28, 2020

CorTechs Labs reports in the study “Performance Evaluation for MS Identification Models”, CorTechs Labs used a recent version of their flagship product, NeuroQuant 3.0, to compute volumetric brain measurements to train an AI algorithm to create machine learning models for different age ranges to classify multiple sclerosis (MS) subjects.

CorTechs Labs evaluated the performance of these models for identifying MS subjects and studied the differences of feature importance selected by the models based on whole and specific age range data. The company will be presenting its findings at the conference around the understanding that studying volumetric changes in the brain can lead to a much deeper understanding of the effects and symptoms of MS as a disease, and that these models may be used as MS classifiers to assist clinicians in decision making.

“We are dedicated to improving patient outcomes and up-leveling the standard of patient care through best in class clinical applications and patient-centric analysis and reporting,” said Chris Airriess, Ph.D., chief executive officer of CorTechs Labs. “Having two very close friends with the disease, I have seen firsthand the impact MS can have on the lives of patients and their families. We work hard every day to provide software solutions to enable early, accurate diagnosis of MS to ultimately help patients get the treatment they need as soon as possible – and to monitor treatment response to ensure the best possible outcomes. The research being presented at ACTRIMS provides hope for furthering these advancements in the diagnosis and classification of MS.”

CorTechs Labs will have the following two poster presentations at ACTRIMS 2020:

Friday, February 28, 11:00 a.m.-12:00 p.m. ET: Performance Evaluation for Multiple Sclerosis Identification Models Based on MR Imaging and Machine Learning (Board No. P183). Presented by Weidong Luo, Ph.D., principal scientist.

Session: Poster Session 2 Lunch

Friday, February 28, 12:00-1:00 p.m. ET: Updated Recommendations for a Standardized MRI Protocol for Multiple Sclerosis (Board No. LB310). Presented by The Consortium of MS Centers in partnership with select experts for their input and co-authorship, including Marilyn Maes, M.S., RT, clinical specialist and Amy Verrinder, vice president of sales.

Session: Poster Session 2 Lunch

CorTechs Labs’ cutting-edge brain imaging analysis provides neurologists, radiologists and clinical researchers worldwide with a convenient and cost-effective means to quantify brain structures to help assess a variety of neurodegenerative conditions.

Stimwave and Nevro Reach Settlement In Patent Infringement Lawsuit

February 28, 2020

For its spinal cord stimulation products only, Stimwave Technologies has agreed to a permanent injunction such that Stimwave’s spinal cord stimulation products will not deliver any therapy that includes pulse frequencies between 1,500 Hz and 100,000 Hz.

Paul LaViolette, Stimwave’s chairman and interim CEO, said, “The new management team at Stimwave is pleased to put this litigation from past management behind us. We will continue to focus commercialization on the tiny form factor of our Freedom neurostimulators, which can be used throughout the body, eliminate the need for large internal batteries, and are fully MRI compatible.” He concluded, “Those attributes are the key to our products’ consistent double-digit annual growth and potential to disrupt both the spinal cord and peripheral nerve neuromodulation market.”

Masimo and MS Westfalia GmbH (MSW) Expand Partnership to Add Masimo SedLine® Brain Function Monitoring, O3® Regional Oximetry, and Oxygen Reserve Index (ORi™) to the MSW Modular Point-of-Care Hybrid Jenny

February 27, 2020

After launching the Jenny modular point-of-care monitoring device with integrated Masimo noninvasive, continuous rainbow SET^® measurements (including total hemoglobin, SpHb^®) and Masimo sidestream and mainstream NomoLine^® capnography, MSW plans to add Masimo Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and Oxygen Reserve Index (ORi™) to Jenny.

By doing so, MSW will make the platform an even more versatile and comprehensive monitoring solution, suitable for use in a variety of care areas, including the ICU and the OR, as well as in EMS and military settings.

The three additional technologies, currently available directly from Masimo on the Root^® Patient Monitoring and Connectivity Platform, are:

Next Generation SedLine Brain Function Monitoring, which assists clinicians in monitoring the state of the brain under anesthesia, with bilateral data acquisition and processing of EEG signals and an enhanced Patient State Index (PSi).
O3 Regional Oximetry, which may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.
ORi, the first noninvasive and continuous parameter to provide insight into the oxygen reserve of patients receiving supplemental oxygen.

Eugen Kagan, CEO of MSW, said, “Our company’s mission is to save lives and improve quality of life for our patients. For more than 25 years, our goal has been to develop products that assist healthcare providers in the hospital and pre-hospital markets by helping to improve patient outcomes and increase patient satisfaction and workflow efficiency – while lowering the cost of healthcare. We accomplish this by developing revolutionary approaches to new product development and by partnering with best-in-class partners like Masimo so we may meet the needs of a constantly changing healthcare landscape. The expanded technology partnership between MSW and Masimo allows us to offer our customers the most innovative technologies, helping them overcome many of the daily challenges they face in healthcare delivery.”

Joe Kiani, Founder and CEO of Masimo, said, “It’s great to see MSW’s commitment to incorporating our full suite of noninvasive, continuous measurements into their all-in-one modular Jenny platform. We are happy to be able to help MSW accomplish its wonderful mission.”

ORi has obtained CE marking and is not available in the U.S.

Spaulding Clinical Research Awarded Five-Year Contract With FDA Division of Applied Regulatory Science

February 27, 2020

The company reports the objectives of each trial vary considerably among different therapeutic areas, but all address important regulatory science questions in today’s pharmaceutical market.

“We are happy to partner with the FDA to help address agency questions about various classes of drugs. Spaulding Clinical is perfectly suited to conduct these trials as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need,” said Cassandra Erato, CEO at Spaulding Clinical Research.

Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years. “We began conducting clinical trials for the FDA to explore a model to screen new drugs for prolongation of QT. Through this work and resulting publications, we have developed a productive partnership,” said Dr. Jay Mason, chief medical officer at Spaulding Clinical Research.

The Glenoid Baseplate includes a Central Screw that has (7) different central screw size length options ranging from 8mm to 20mm in 2mm increments. This provides an alternative to the glenoid baseplate having a central post and post extensions that FX currently has available to the US market.

Acquisition of Vigilenz was announced on February 4, 2020.

Torchia and Tyc, both from Winnipeg, Manitoba, founded Monteris Medical in 1999 with the sole focus of helping patients who suffer from neurological diseases.

For its spinal cord stimulation products only, Stimwave Technologies has agreed to a permanent injunction such that Stimwave’s spinal cord stimulation products will not deliver any therapy that includes pulse frequencies between 1,500 Hz and 100,000 Hz.

The company reports the objectives of each trial vary considerably among different therapeutic areas, but all address important regulatory science questions in today’s pharmaceutical market.

Medical Device News Magazine