CHICAGO (January 3, 2025): Intermountain Health St. Mary’s Regional Hospital in Grand Junction Colorado was awarded ACS/SVS Vascular-VP designation on November 19, 2024. By achieving this prestigious status, Intermountain Health St. Mary’s Regional Hospital shows their commitment to delivering high quality treatment for patients receiving vascular surgical and interventional care […]
Peripheral/Endo
Surmodics Announces Successful Early Clinical Use of Pounce™ XL Thrombectomy System, Suitable for Non-Surgical Removal of Thrombi and Emboli from Iliac and Femoral Arteries
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the successful early clinical use of its Pounce™ XL Thrombectomy System. The Pounce XL Thrombectomy System received U.S. Food and Drug Administration (FDA) 510(k) clearance […]
Stereotaxis Announces First GenesisX Robotic System Order
ST. LOUIS, Jan. 30, 2025 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it has received the first order for its latest generation robotic system, GenesisX™.
Cagent Vascular Initiates the Serranator® POINT FORCE Observational Registry
WAYNE, Penn.–(BUSINESS WIRE)–Cagent Vascular, Inc., the exclusive developer of serration technology for vessel dilation in endovascular interventions, today announced the start of the POINT FORCE Registry, a post-market clinical follow-up study of the Serranator® PTA Serration Balloon Catheter. “What we endeavor to understand In POINT FORCE is the role Serranation can […]
Instylla Announces FDA Clearance of Tembo™ Embolic System
BEDFORD, Mass., Jan. 28, 2025 /PRNewswire/ — Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, has announced the FDA 510(k) clearance of the Tembo™ Embolic System. The Tembo Embolic System is a bioresorbable1 embolization…
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…
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 creation of an AV fistula for hemodialysis vascular access. LOS […]
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,…