A Publication for the Practising Medical Specialist, Industry Executive

Medical Device News Magazine delivers the latest updates from the medical device and biotechnology sectors. 

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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook

Endologix DETOUR™ System

Endologix Receives FDA Approval of the DETOUR System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

“We are delighted to receive FDA approval of the DETOUR System,” said Matt Thompson, MD, President, and CEO of Endologix. “PTAB therapy represents a significant step forward for patients with complex PAD, they have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the U.S. through a targeted market release in the coming weeks.”

Magenta Medical Reports 1st Patients Treated in the US with the World’s Smallest Heart Pump

“Magenta Medical CEO Dr. David Israeli, CEO said, “Magenta is proud to partner with top cardiology centers in the United States to further the validation of its technology and provide cardiologists with a powerful tool to support their high-risk patients during complex procedures. We are looking forward to a speedy recruitment process and favorable study outcomes that would allow us to take the next step in the clinical program towards ultimate market approval.”

Clinical Trials

Stanford Spinoff PhysioWave Announces Clinical Study with Omron Healthcare

The PhysioWave Pro™ scale measures the stiffness of the major blood vessel into which the heart pumps, the aorta. Stiffness increases with age, but excess stiffness among people of similar ages can be a warning sign of risk. It is established that increased vascular stiffness can predict the later development of high blood pressure, or hypertension, and a higher risk of cardiovascular disease.

MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA

SFA SELUTION4SFA is being conducted in over 30 centers in the US plus an additional 10 centers worldwide. The study will enroll 300 patients, with the aim of demonstrating the superiority of SELUTION SLR over balloon angioplasty (POBA). The primary efficacy endpoint is primary patency of the target lesion at 12 months and the primary safety endpoint is freedom from death at 30 days. Enrollment into the study will be complete by the end of 2023.

Venock closure device

Economic Study Shows Significant Cost Savings when Using Venock Device for Large Bore Venous Access Site Closure

According to a new study, this device could provide cost savings of more than $1,700 per procedure. In addition, the device will enable same-day patient discharge providing a cost savings of up to $6,290 per patient. The Venock device replaces the tedious and lengthy manual compression steps currently used to close venous access sites after a catheterization – a decades old procedure that is extremely burdensome to patients. Medical approval of the device is forthcoming.

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Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry

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Healthcare: Understanding the Business Side of the Industry and Its Implications

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Health: A Comprehensive Exploration of Wellness, Nutrition, and Overall Well-Being for a Healthier Life

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