Tag: Medtronic

Medtronic Shows Off Early Intrepid TMVR Data

DUBLIN and DENVER – November 1, 2017 – Medtronic (NYSE:MDT) today presented positive data for its self-expanding Intrepid(TM) transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation. Presented as a First Report Investigation at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting and simultaneously published in the Journal of the American […]

Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil® drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in […]

First Patient Treated in Medtronic’s Landmark Transcatheter Mitral Valve Replacement (TMVR) Pivotal Trial

DUBLIN – October 23, 2017 – Medtronic (NYSE:MDT) today announced the first patient implant in the APOLLO Trial – the pivotal trial designed to evaluate the Intrepid(TM) TMVR system following receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). As the first-ever pivotal trial for transcatheter […]

Medtronic (MDT)’s Stent System Wins FDA OK to Treat Short Neck Anatomies When Used With Heli-FX EndoAnchor System

DUBLIN – October 9, 2017 – Medtronic plc (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (FDA) approval for the Endurant(TM) II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients with neck lengths down to 4mm and <=60° infra-renal angulation when used in combination […]

Medtronic HeartWare(TM) HVAD(TM) System Approved for Destination Therapy

DUBLIN – September 27, 2017 – Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for its HeartWare(TM) HVAD(TM) System as a destination therapy for patients with advanced heart failure who are not candidates for heart transplants. The HVAD System, a left ventricular assist device or LVAD, […]

Medtronic (MDT) Announces Clinical Study To Evaluate The Corevalve Evolut PRO System In ‘Everyday’ Clinical Practice

DUBLIN – September 21, 2017 – Medtronic plc (NYSE: MDT) today announced a new post-market clinical study to evaluate its CoreValve(TM) Evolut(TM) PRO valve in everyday clinical practice. Studying patients with severe symptomatic aortic stenosis at an intermediate, high or extreme risk for open heart surgery, the FORWARD PRO Clinical Study […]

Medtronic (MDT) Shows Off New 5-Year Subset Data From Endurant AAA Stent Graft Trial

DUBLIN and LAS VEGAS – September 13, 2017 – Medtronic plc (NYSE: MDT) today reported its Endurant® II abdominal aortic aneurysm (AAA) stent graft system continues to demonstrate long-term durability and consistent outcomes in a real-world setting among both male and female patients. The five-year ENGAGE global registry data were presented […]

Medtronic (MDT) IN.PACT Admiral DCB Global Two Year Data And IN.PACT SFA Four Year Data Presented In VIVA Late Breaking Clinical Trials

DUBLIN and LAS VEGAS – September 12, 2017 – Medtronic plc (NYSE: MDT) data announced today reinforce the durability and safety of the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The two-year, real-world results from the full clinical cohort of the IN.PACT Global Study and four-year […]

Medtronic (MDT) Announces Japanese Regulatory Approval For The IN.PACT Admiral Drug-Coated Balloon

DUBLIN – September 8, 2017 – Medtronic plc (NYSE: MDT) today announced that the IN.PACT(TM)Admiral(TM) Drug-Coated Balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg – specifically, in the thigh (superficial femoral arteries (SFA)) and […]

Medtronic Plans for Renal Denervation Pivotal Trial After New Study Shows Significant Blood Pressure Reductions

Published Simultaneously in The Lancet, the Late-Breaking SPYRAL HTN-OFF MED Study at ESC Successfully Isolates RDN Treatment Effect to Show Compelling Efficacy and Safety of Hypertension Procedure DUBLIN and BARCELONA – August 28, 2017 – Medtronic plc (NYSE:MDT) today announced its intent to move forward with a new renal denervation pivotal trial […]