Tag: PAD

VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel PrepTM System

Minneapolis, Minnesota, September 6, 2023 – VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification. Gaining MDR certification […]

Avinger Announces Conversion of 12% of CRG Term Debt into Equity

REDWOOD CITY, CA / ACCESSWIRE / August 4, 2023 / Avinger, Inc. (Nasdaq:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease, today announced the conversion of approximately 12% of its existing debt with entities affiliated with CRG Partners III […]

Endologix Announces First Patients Treated with the DETOUR™ System, Advancing Treatment for Complex Peripheral Artery Disease

IRVINE, Calif.–(BUSINESS WIRE)–Endologix Inc. a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the first patients underwent Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR system, since FDA approval of the system was granted. This marks the official […]

Dr. Mehdi H. Shishehbor Appointed Chief Medical Officer of Inquis Medical

REDWOOD CITY, Calif., July 12, 2023 (GLOBE NEWSWIRE) — Inquis Medical, Inc., a privately held medical device company focused on peripheral vascular innovations, today announced the appointment of distinguished interventional cardiologist and scholar, Mehdi H. Shishehbor, DO, MPH, Ph.D., as Chief Medical Officer. Dr. Shishehbor is the President of University Hospitals […]

Cagent Vascular announces initial RECOIL Study results: Serranator demonstrates 49% less recoil than POBA in BTK arteries

WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, the exclusive developer of serration technology for vessel dilatation in endovascular interventions, announced the results of its Below-the-Knee (BTK) RECOIL study. This Core Lab-Adjudicated Recoil analysis, the first of its kind, evaluated vessel recoil in lesions treated with Serranator® verses Plain Old Balloon Angioplasty (POBA). The […]

ZyVersa Therapeutics Announces a Publication in Journal of the American Heart Association Linking NLRP3 Inflammasomes with Calcification in Arteries of Patients with Peripheral Arterial Disease (PAD)

PAD, characterized by vascular inflammation and associated calcification, affects 8.5 million people in the United States and contributes to more than 50,000 limb amputations annually, yet there are no specific pharmacologic treatments ZyVersa is developing Inflammasome ASC Inhibitor IC 100 for numerous inflammatory diseases WESTON, Fla., June 20, 2023 (GLOBE […]

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

IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Over […]

Semler Scientific Comments on CMS Risk Adjustment Changes in the 2024 Medicare Advantage and Part D Final Rate Announcement

SANTA CLARA, Calif., April 3, 2023 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, commented on the recent Centers for Medicare and Medicaid Services (CMS) 2024 Medicare Advantage and Part D Final Rate Announcement. “Semler Scientific remains confident that screening […]

Landmark New England Journal of Medicine Publication Reports Positive Results From PROMISE II Pivotal Trial Showing that LimFlow System Saves Most Patients with End-stage Peripheral Artery Disease From Major Amputation

PROMISE II Trial Met Primary Endpoint Therapy Demonstrates 76% Limb Salvage in Patients with Chronic Limb-Threatening Ischemia Who Otherwise Faced Amputation PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today […]

According to THE SAGE GROUP, High Restenosis Rates Following Endovascular Treatment of Infrapopliteal Disease Create a Significant Need for Improved Technologies

BEAUFORT, S.C.–(BUSINESS WIRE)–Recent research published by THE SAGE GROUP examines the challenges of infrapopliteal Peripheral Artery Disease (PAD) and incidence of restenosis. “It is difficult to reach strong conclusions regarding device superiority for endovascular treatment of infrapopliteal disease,” stated Mary L. Yost, President of THE SAGE GROUP. “This reflects limitations […]