Regulatory

GORE RECEIVES FDA APPROVAL FOR BREAKTHROUGH ENDOVASCULAR DEVICE IN COMPLEX AORTIC ANEURYSMS

The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis approval brings the first branched, all-in-one solution for patients with thoracoabdominal aortic aneurysms and high-surgical risk patients with pararenal aortic aneurysms in patients with appropriate anatomy.   “TAMBE is an innovative first step forward that enables […]

CroíValve Announces FDA IDE Approval and Initiation of its Early Feasibility Study

DUBLIN–(BUSINESS WIRE)–CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study (EFS) for the DUO™ Tricuspid Coaptation Valve System, following FDA IDE and CMS approval. The […]

AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter to Treat Peripheral Arterial Disease

LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that the United States Food […]

Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure

PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 23 January 2024, 07:00 am CET DSMBi rates DSR 2.0 as safe following review of data from non-randomized cohort Data from non-randomized cohort confirms dramatic improvement in diuretic response and at least 95% […]

Nectero Medical Announces Initiation of Phase II/III Clinical Trial of the Nectero EAST® System for Treatment of Small- to Medium-Sized Abdominal Aortic Aneurysms

TEMPE, Ariz.–(BUSINESS WIRE)– #AbdominalAorticAneurysm–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease and improve patients’ lives, today announced initiation of a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm. The Nectero EAST System is a single-use,

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions

San Clemente, CA—Jan. 15, 2024 – Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. The […]

Endovascular Engineering’s Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

MENLO PARK, Calif., Jan. 11, 2024 /PRNewswire/ — Endovascular Engineering (“E2”), a medical device company focused on the development and deployment of groundbreaking clot removal technologies that target venous thromboembolism (VTE), announced today FDA Investigational Device Exemption…