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Tuesday, October 23, 2018






In the Spotlight

Medical Device News Magazine reports breaking news including clinical trial updates, product launches, profiles of device companies, acquisitions, executives on the move, non-profit and medical society news and more. Read with great interest by practicing medical specialists, industry executives, investors and other allied health professional. We invite you to visit our magazine daily!


Companies Who Made the Cut!
10/22/18: The study is an FDA approved physician-sponsored investigational device exemption (IDE) study, administered in conjunction with Harborview Medical Center and run by Dr. Benjamin Starnes, Chief of Vascular Surgery at the University of Washington (UW). Endovascular Aneurysm Repair (EVAR) is the gold standard for treatment of Abdominal Aortic Aneurysms (AAA).
10/22/18: Initially indicated for use in gallbladder removal procedures, the shaftless Magnetic Surgical System reduces the number of incisions necessary for the indicated procedures.
10/22/18: "The primary aim of this study was to examine the effects of radiation treatment on AeroForm Tissue Expanders and to describe the planning protocol for these patients. Our findings revealed that it is feasible to plan with a conventional 3D planning technique that is reproducible and the early outcomes of AeroForm patients treated with external beam radiation therapy are similar to patients without AeroForm Tissue Expanders," said Dr. Yvonne Zissiadis, Genesiscare, Lead Investigator of the study.
10/22/18: Powered by Analogic, the FCT Embrace is the world’s first 85cm wide bore computed tomography (CT) imaging unitwith 64 or 128 slice configurations.
10/19/18: The letter relates to Ocular’s compliance with data collection and information reporting obligations in a post-approval Device Exposure Registry study required as a condition for approval of the premarket approval (PMA) application for ReSure® Sealant.
10/19/18: “The Aquilion Precision sets a new bar for CT imaging,” said Dominic Smith, senior director, CT, PET/CT, and MR Business Units, Canon Medical Systems USA. “With the highest level of resolution available in the CT market, our customers have the ability to better visualize disease, which can potentially help clinicians in treatment planning.”
10/19/18: With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives.
10/17/18: New data, published online in JAMA Cardiology, found a new blood test under development that is done right at the patient's side in as little as 15 minutes could identify nearly three-fifths (56.7 percent) of people at low-risk of experiencing a heart attack, similar to the results of a High Sensitive Troponin-I blood test done in the laboratory setting.
10/17/18: The results are from a real-world case study conducted by David A. Berman, M.D., FAAD, a leading hair restoration surgeon, founder of the Berman Skin Institute in California and one of the first users of the ARTAS iX System, and he developed a poster entitled “Robotic, AI-assisted Follicular Unit Excision And Implantation For Hair Restoration With ARTAS iX” during the American Society for Dermatologic Surgery (ASDS) Annual Meeting 2018.
10/17/18: The primary purpose of this multi-center, randomized study is to evaluate safety and tolerability of SetPoint’s proprietary device, which is surgically placed on the vagus nerve. The study includes 14 subjects who had failed or were intolerant to multiple, mechanistically different, biologic therapies. Initial feedback from neurosurgeons performing the implantation has been positive. The company anticipates data readout in the first quarter of 2019.
10/17/18: The CALIBER study, the first randomized controlled clinical trial to compare the anti-reflux procedure to proton pump inhibitors (PPIs), the standard of medical care for GERD treatment, was published in GIE: Gastrointestinal Endoscopy, the peer-reviewed journal of the American Society for Gastrointestinal Endoscopy (ASGE).
10/16/18: “One of the core values of Ackerman Cancer Center is to ensure patients have access to the most effective and innovative cancer therapies available. Through the use of Proton Therapy, our physicians have witnessed better tolerance in patient treatments, excellent overall outcomes and healthier patients post treatment,” said Scot Ackerman, MD, Medical Director of Ackerman Cancer Center.
10/16/18: The article describes the periprocedural and short-term outcomes of patients with severe MR and previous surgical aortic valve prosthesis replacement treated with the Tiara. The article describes procedural success rate of 100% with no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days.
10/16/18: "The Control Workflow assists me in identifying appropriate patients who could benefit from targeted drug delivery using the Medtronic pain pump, which is especially important with the current opioid epidemic in the United States," said John A. Hatheway, M.D., owner and provider, Northwest Pain Care, Spokane, Wash.
10/15/18: The product will be available for shipment following its display at the American Society for Radiation Oncology (ASTRO) Meeting taking place October 21-24, 2018 in San Antonio, Texas.
10/15/18: In addition, the company also announced expanded patient enrollment and study sites in the SAVE-US (Surfacer System to Facilitate Access in VEnous Occlusions – United States), a pre-market investigational device exempt study.
10/15/18: The study is designed to demonstrate the extent to which changes in SOZO® BIS measurements preempt patient-reported symptoms of HF that lead to hospital readmissions.
The Food and Drug Administration (FDA) has approved the ID CORE XT molecular diagnostic test for in-vitro diagnostic (IVD) use in the United States....

Market Reports

Cardiac Biomarker Diagnostic Test Kits Market Would Reach US$ 2,540.8 Mn by 2028

10/16/18: the global cardiac biomarker diagnostic test kits market is projected to expand at a CAGR of 5.1% during the forecast period 2018-2028 and reach US$ 2,540.8 Mn by the end of 2028.

Urolithiasis Management Devices Market to Earn US$1.78 Billion by 2024 With Rising Number of Geriatric Population

10/5/18: As per the TMR report, the global urolithiasis management devices market is estimated to earn US$1.78 bn by the end of 2024. The market is presumed to expand to 4.5% CAGR within the forecast period of 2016 to 2024.

Global Left Ventricular Assist Device Market Outlook to 2023

10/5/18: The Global Left Ventricular Assist Device Market was worth 1024 Million USD in 2017 and it is estimated to grow to 1860 Million USD by 2023 with a CAGR of 10.46% between 2017 and 202

Global In Vitro Toxicology Testing Market 2018-2024 by Toxicology Endpoints, Industry Type, and Regions

10/5/18: The global in vitro toxicology testing market is estimated to witness a CAGR of 8.2% during the forecast period 2018-2024.

The Infusion Therapy Devices Market in India 2018-2024

9/25/18: The current lack of medical personnel is one of the major obstacles to the growth of the infusion therapy device market in India.

Surgical Sutures Market to Gain Revenue Worth US$ 5080.1 Mn by 2025

9/20/18: Rising demand for carrying out surgical activities owing to an increase in healthcare issues as well as external situations such as accidents is primarily driving the global surgical sutures market. With increasing geriatric population, a surge in serious healthcare ailments have reportedly occurred, many of which might need surgical treatments.

Kidney Stone Management Devices Market to Reach US$ 1,500 Million by 2028

9/20/18: Rising preferences for minimally-invasive and non-invasive surgical procedures continues to be a massive trend in the kidney stone management devices market. Growing incidence rate of kidney stones, combined with the availability of affordable minimally invasive treatment is likely to sustain demand for kidney stone management devices during the forecast period 2018-2028. The report opines that manufacturers will be hard-pressed to develop innovative devices for large stones, as it has remained a longstanding challenge for healthcare providers.

Executives on the Move

10/22/18: Laura Iversen will be responsible for all aspects pertaining to the operations and manufacturing of our Advanced Energy portfolio.
10/22/18: Michael Mrochen is internationally known for his pioneering work on corneal laser surgery, corneal cross linking, ocular biometry and cornea inlays for presbyopia and hyperopia.

Financial Healthcare Conferences

10/22/18: President and CEO, Bjarne Bergheim had this to say about the event, "Sonendo was honored to win the Red Herring Top 100 Global in 2017, and since then we have experienced exponential growth due to market demand for the GentleWave Procedure. I look forward to presenting at this year's event and sharing the continuation of our remarkable journey."
10/16/18: Aethlon Medical is focused on addressing unmet needs in global health. The Aethlon Hemopurifier® is clinical-stage immunotherapeutic device candidate to combat cancer and life-threatening viral infections. The Hemopurifier® has been designation a "Breakthrough Device" by United States Food and Drug Administration (FDA) related to the treatment of life-threatening viruses that are not addressed with approved therapies.


10/16/18: "This generous gift will improve the lives of countless patients who suffer from debilitating complications or need revision surgery due to failed implants," said Thomas P. Sculco, MD, surgeon-in-chief emeritus and director of the CJRC at HSS. "We are deeply honored by the visionary leadership of the SNF in supporting our endeavor to lessen implant failure, restore function, and relieve pain for patients who need specialized joint reconstructions."