Tag: Medtronic

Medtronic Receives FDA Approval for Trial Evaluating New Energy Source with Pulsed Electric Fields to Treat Atrial Fibrillation

Investigative Technology Designed to Interrupt Irregular Pathways in the Heart DUBLIN, Jan. 23, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field […]

FDA Approves Medtronic Micra™ AV, the World’s Smallest Pacemaker Which Can Now Treat AV Block

With FDA Approval, More Patients in the U.S. Are Now Candidates for a Leadless Pacing Option DUBLIN, Jan. 21, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval of Micra™ AV, the world’s smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is […]

Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions

Clinical Data Demonstrates IN.PACT™ AV DCB Is Safe, Reduces Reinterventions, and Maintains Access for End-Stage Renal Disease Patients Undergoing Dialysis DUBLIN, Nov. 21, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the IN.PACT™ AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the […]

New Study Shows Promise in Treating More Patients with World’s Smallest Pacemaker

Data Published in JACC: Clinical Electrophysiology and to be Presented at American Heart Association Scientific Sessions Demonstrates the Potential of Investigational Algorithms in Medtronic Micra Pacemaker to Improve Synchrony and Cardiac Function in AV Block Patients DUBLIN, Nov. 11, 2019 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced results from the MARVEL […]

Medtronic Announces Shonin Approval and Launch of the Valiant Navion™ Thoracic Stent Graft System in Japan

Lower-Profile Thoracic Endovascular Aortic Repair (TEVAR) Device Continues to Broaden Global Treatable Patient Population with Thoracic Aortic Disease DUBLIN, Oct. 31, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) and the launch of the Valiant Navion™ thoracic stent graft system […]

Medtronic Receives FDA “Breakthrough Device Designation” for Developing Fully Implantable Heart Pump

DUBLIN, Oct. 29, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development. […]

FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated in March 2019 as Class I Recall

DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]

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 […]