Tag: Medtronic

Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm

News Follows Medtronic Receiving FDA Breakthrough Device Designation for its Valiant Navion™ LSA Branch Thoracic Stent Graft System DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System […]

Medtronic Initiates Worldwide Pivotal Study of a New Approach to Treating Dangerously Fast Heart Rhythms

Study to Evaluate Novel Implantable Defibrillator System with a Lead Placed Outside the Heart and Veins DUBLIN, Oct. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the start of a worldwide pivotal study evaluating its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system to treat dangerously fast heart rhythms. The […]

Medtronic Announces Early Feasibility Trial for Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal Approach

New Study Shows Momentum in Establishing a Less Invasive Approach to Treat Patients with Severe Mitral Valve Disease DUBLIN, Sept. 27, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval to begin an early feasibility study (EFS) for its Intrepid™ transcatheter mitral […]

Resolute Onyx™ DES Meets Primary Endpoint in First-Ever Clinical Study Comparing Drug-Eluting Stents in High-Bleeding Risk (HBR) Patients with One-Month DAPT

DUBLIN and SAN FRANCISCO, Sept. 26, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) announced today late-breaking clinical data from the Onyx ONE Global Study, representing the first prospective, multi-center, randomized study evaluating clinical outcomes between two drug-eluting stents (DES) in nearly 2,000 high-bleeding risk (HBR) patients with one month of dual antiplatelet therapy […]

Medtronic Announces FDA Approval and U.S. Launch of Next-Generation Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients

Improved Functionality Across Four Valve Sizes and Lowest Delivery Profile on the Market, the Evolut PRO+ TAVR System Launches in U.S. as TAVR Patient Population Grows DUBLIN, Sept. 23, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration […]

IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints

IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with […]

Medtronic EVP & CVG President Mike Coyle to Speak at Wells Fargo Securities Healthcare Conference

DUBLIN, Aug. 29, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it will participate in the 14th Annual Wells Fargo Securities Healthcare Conference on Thursday, September 5, 2019, in Boston. Mike Coyle, executive vice president and president of the Cardiac and Vascular Group (CVG) […]

Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR) system for patients with symptomatic severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is […]

Medtronic Launches the VenaSeal Closure System in India to Treat Patients With Chronic Venous Diseases

Newly Approved Minimally Invasive Therapy Treats Diseased Veins Using Proprietary Medical Adhesive Mumbai, Maharashtra, India:  India Medtronic Private Limited, wholly owned subsidiary of Medtronic plc (NYSE: MDT), today announced the launch of the VenaSeal™ Closure System, which is a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased vein […]