Peripheral/Endo

Patty Vila Joins the Amavita Foundation Board, Bringing Two Decades of Strategic Media Expertise to Amplify Heart and Vascular Health Initiatives

MIAMI, Jan. 21, 2025 /PRNewswire/ — The Amavita Foundation, a leading organization dedicated to advancing cardiovascular health and supporting patients facing chronic limb-threatening ischemia (CLTI), is pleased to announce the appointment of Patty Vila to its Board of Directors. A…

R3 Vascular Secures WCG IRB Approval and CMS Category B Medicare Coverage for the ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

MOUNTAIN VIEW, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that it received WCG Institutional Review Board (IRB) approval for the ELITE-BTK Pivotal Trial of its MAGNITUDE Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease (PAD). This approval allows the trial to take place at institutions that utilize WCG IRB as their central IRB in the United States. Additionally, the company announced that the Centers for Medicare & Medicaid Services (CMS) has granted Category B approval for the investigational device exemption (IDE) study, ensuring Medicare coverage for the device, related and routine items, and services for the ELITE-BTK trial.

Argon Medical Announces First Patient Enrollment in CLEAN-PE, a Prospective, Multicenter Study of a New Treatment for Pulmonary Embolism

PLANO, Texas, Jan. 9, 2025 /PRNewswire/ — Argon Medical Devices, a leading provider of device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology procedures, announced the first patient enrollment in the CLEAN-PE study. The prospective,…

Simpson Interventions Announces both IDE approval from FDA for Acolyte™ Catheter System and 510(k) clearance for its Shadow Catheter™, adds Board Member

CAMPBELL, Calif.–(BUSINESS WIRE)–Simpson Interventions, Inc., a pioneering medical technology company, specializing in cardiovascular interventional devices, today announced achievement of major development milestones. Its truly unique Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption by […]

InspireMD Announces First Patient Enrolled in the CGUARDIANS II Pivotal Study of the CGuard Prime Carotid Stent System in Transcarotid Artery Revascularization Procedures (TCAR)

Study represents a significant step forward in Company’s mission to serve the broadest set of physician and patient needs with best-in-class CAS and TCAR solutions Study represents a significant step forward in Company’s mission to serve the broadest set of physician and patient needs with best-in-class CAS and TCAR solutions