Peripheral/Endo

Efemoral Medical Announces Successful First-In-Human Use of The Efemoral™ Vascular Scaffold System

New bioresorbable treatment option aims to improve outcomes for patients suffering from peripheral arterial disease LOS ALTOS, Calif., Dec. 14, 2020 /PRNewswire/ — Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced the first-in-human (FIH) use of the company’s Efemoral™ Vascular Scaffold System (EVSS) with FlexStep™ Technology in the EFEMORAL I FIH clinical study. […]

Sirtex Medical announces strategic investment in BlackSwan Vascular, Inc.

Agreement includes investment to support clinical trials for potential first FDA-approved liquid embolic system for a peripheral vascular indication and option to acquire the company WOBURN, Mass., Dec. 9, 2020 /PRNewswire/ — Sirtex Medical (Sirtex), a leading manufacturer of targeted liver cancer therapies, announced a strategic investment in BlackSwan Vascular, Inc. (BlackSwan), a Bay […]

Aidoc and Imbio partner to provide an industry first AI solution to prioritize suspected pulmonary embolism and automatically calculate RV/LV ratio

NEW YORK, Dec. 3, 2020 /PRNewswire/ — Aidoc, the leading provider of enterprise AI solutions, and Imbio, a leading provider of medical image analysis for pulmonary and cardiothoracic diseases, announced today a partnership intended to provide the world’s first end-to-end AI solution for pulmonary embolism (PE), with the goal of ultimately improving efficiency and quality […]

Vesper Medical Announces First Enrollment in the VIVID Trial

Company Initiates Pivotal Clinical Study for Next Generation Deep Venous Stent MALVERN, Pa.–(BUSINESS WIRE)–Vesper Medical, Inc., a developer of medical devices for deep venous disease, today announced initiation of its U.S. Food and Drug Administration (FDA) Investigational Exemption (IDE) study – Venous stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous […]

MedAlliance announces successful completion of enrolment in ISABELLA clinical trial for the treatment of failing AV fistulas in hemodialysis patients

NYON, Switzerland, Nov. 24, 2020 /PRNewswire/ — MedAlliance has announced completion of patient enrolment in the ISABELLA Clinical Trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing hemodialysis. SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained […]

Hancock Jaffe’s VenoValve(R) Results Featured in Journal of Vascular Surgery Venous and Lymphatic Disorders

Preliminary First-in-Human Study Results Published in Peer-Reviewed Journal IRVINE, CA / ACCESSWIRE / November 23, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that the Journal of Vascular Surgery Venous and Lymphatic Disorders, published a paper featuring interim […]

Penumbra’s Newest Generation of Indigo Aspiration System Receives FDA Clearance for Pulmonary Embolism

Lightning 12 and Separator 12 Now Indicated for Treatment of PE ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo® Aspiration System, Lightning™ 12. As part of […]

Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt

Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial […]

INFINITY ANGIOPLASTY BALLOON CATHETER™ Completes First-In-Human PRECISION ANGIOPLASTY™

TOLEDO, Ohio, Nov. 17, 2020 /PRNewswire/ — INFINITY ANGIOPLASTY BALLOON CO., announced today that its innovative PRECISION ANGIOPLASTY™ balloon platform – INFINITY ANGIOPLASTY BALLOON CATHETER™ has successfully completed First-in-Human clinical trial. Recently cleared by the FDA for PTA treatment of peripheral artery disease including: iliac femoral popliteal infra-popliteal arteries for the treatment of […]

TISSIUM Receives FDA Investigational Device Exemption for Vascular Sealant

IDE Approval Clears Path to U.S. Clinical Trial Launch for Vascular Sealant PARIS–(BUSINESS WIRE)–TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, announced today it has received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption application for its vascular sealant. The approval […]