Peripheral/Endo

Innova Vascular Completes Enrollment in Trust IDE Study Evaluating the Laguna Thrombectomy System for Pulmonary Embolism

IRVINE, CA, UNITED STATES, August 31, 2026 /EINPresswire.com/ — Innova Vascular, Inc., a medical technology company developing innovative endovascular solutions for the treatment of vascular thromboembolism, today announced the completion of patient enrollment in the TRUST pivotal Investigational Device Exemption (IDE) clinical study evaluating the safety and effectiveness of the Laguna® Thrombectomy […]

Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter

New device expands Vesalio’s pVasc platform with integrated clot-capture technology designed to retain clot fragments during retrieval. DALLAS, Aug. 13, 2026 /PRNewswire/ — Vesalio, a global leader in vascular intervention, today announced that the U.S. Food and Drug Administration (FDA)…

FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System

The U.S. pivotal study will evaluate FastWave’s electric IVL system in patients with peripheral artery disease. MINNEAPOLIS, Aug. 11, 2026 /PRNewswire/ — FastWave Medical, which is developing next-generation intravascular lithotripsy (IVL) technology, has received FDA approval of its Investigational Device Exemption (IDE) application, which clears the company to begin a U.S. pivotal trial of its ArteroTM electric IVL […]

FDA APPROVES LABELING UPDATE REFLECTING EVIDENCE IN RUPTURED AAA FOR GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

FLAGSTAFF, Arizona (July 7, 2026)—W. L. Gore & Associates’ medical business (“Gore”) announced today that the U.S. Food and Drug Administration has approved updated labeling for the GORE® EXCLUDER® AAA Endoprosthesis and the GORE® EXCLUDER® Conformable AAA Endoprosthesis, adding real‑world clinical evidence that supports the use of EVAR devices in appropriately selected patients with ruptured abdominal aortic […]

Shape Memory Medical Completes Enrollment in Landmark AAA‑SHAPE Randomized Controlled Pivotal Trial

SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of the only commercially available volume‑expanding shape memory polymer for endovascular embolization, announced today that it has completed enrollment in the AAA‑SHAPE Pivotal Trial, a prospective, multicenter, randomized, open‑label controlled study evaluating the safety and effectiveness of the IMPEDE‑FX RapidFill® Device when used alongside endovascular aneurysm repair, or EVAR, to improve abdominal aortic aneurysm (AA