Author: Ken Dropiewski

ABRE Study Meets Primary Safety and Effectiveness Endpoints

Medtronic Self-Expanding Venous Stent Demonstrates Favorable Outcomes in Patients with Venous Outflow Obstruction DUBLIN and LONDON, June 16, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the first-ever results from the ABRE clinical study assessing the safety and effectiveness of the investigational Abre™ venous […]

INFINITY ANGIOPLASTY BALLOON CATHETER™ RECEIVES 510(k) CLEARANCE

[Dateline: Toledo, Ohio, June, 2020]-INFINITY ANGIOPLASTY BALLOON CO., announced today that its innovative balloon platform – INFINITY ANGIOPLASTY BALLOON CATHETER™ has been cleared by the FDA for PTA treatment of peripheral arterial disease, in peripheral vasculature including iliac, femoral, popliteal, infra-popliteal arteries and for the treatment of AV dialysis fistulae.   […]

Endologix Issues Correction Notice for Ovation iX Abdominal Stent Graft System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that a correction notice has been issued for the Ovation iX system, that identifies the root cause of polymer leaks. This voluntary action has been classified by the FDA […]

CardioFocus® Announces Initial Commercial Procedures Following US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

MARLBOROUGH, Mass., June 16, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm disorder. Henry D. Huang, M.D., FACC, […]

Introducing The StopAfib.org Library Collection of No-Cost Videos for Atrial Fibrillation Patients

DALLAS, June 16, 2020 /PRNewswire/ — The StopAfib.org Library, an invaluable collection of video resources for people living with atrial fibrillation (afib), is now available at no cost. The world-renowned StopAfib.org patient advocacy organization empowers those living with afib to take control of their treatment and get their lives back. This one-stop source […]

Contego Medical Announces the Start of Enrollment in the PERFORMANCE II Carotid Stenting Clinical Trial

RALEIGH, N.C., June 15, 2020 /PRNewswire/ — Contego Medical, Inc. today announced enrollment of the first patient in the PERFORMANCE II Trial evaluating the safety and effectiveness of the Neuroguard IEP® 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection. The Neuroguard IEP System is designed to treat […]

Keystone Heart, A Venus Medtech Company, Acquires 510 Kardiac Devices, Inc.

TAMPA, Fla., June 16, 2020 /PRNewswire/ — Keystone Heart, LTD., a medical device innovator driven to redefine the standard of structural heart care, today announced it has acquired 510 Kardiac Devices, Inc., a privately-held medical device company and makers of the Lim Transseptal System. The Lim Transseptal System was designed to meet the demands […]

Proximo Medical and Coala Life Partner for Commercialization in Select U.S. Markets

CASTLE PINES, Colo., June 16, 2020 /PRNewswire/ — Today Proximo Medical, LLC, a business acceleration solution that addresses medical device commercialization challenges among startup and established medical device technologies looking to expand adoption in the U.S., announced a partnership with Coala Life, a leading Swedish-headquartered digital health company, in select U.S. markets. The COALA® Heart Monitor provides […]

MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR™ Sirolimus Drug Eluting Balloon

MUMBAI, India, June 16, 2020 /PRNewswire/ — MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad […]