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…
Peripheral/Endo
SIRPAD – WORLD’S LARGEST RCT INVESTIGATING MAGICTOUCH PTA SIROLIMUS COATED BALLOON COMPLETES PATIENT ENROLMENT
TAMPA, Fla., Jan. 20, 2025 /PRNewswire/ — Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled. The…
Venova Medical Announces First Subjects Enrolled in VENOS-2 IDE Study of the Velocity Percutaneous AVF System
The VENOS-2 prospective, multicenter study is being performed under an Investigational Device Exemption (IDE) granted by the FDA and will evaluate the feasibility of the company’s Velocity pAVF System which is designed to enable a minimally invasive approach for the […]
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 […]
FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
SILVER SPRING, Md., Dec. 20, 2024 /PRNewswire/ — The U.S. Food and Drug Administration approved Symvess, the first acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization (restoration of blood flow)…
Microbot Medical® CEO Harel Gadot to Discuss Endovascular Robotics on Benzinga All Access
Livestream Interview Can be Viewed Today at 10:50am ET at Benzinga All Access Live
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
Merit Medical’s WRAPSODY WAVE Trial Exceeds Performance Goals for Arteriovenous Graft (AVG) Patients
WRAPSODY achieves 82% target lesion primary patency at six months in the single-arm cohort of the US pivotal trial WRAPSODY achieves 82% target lesion primary patency at six months in the single-arm cohort of the US pivotal trial