Tag: Medtronic

Medtronic Begins New Pilot Study as Part of SPYRAL HTN Clinical Program for Renal Denervation in Hypertension Patients

SPYRAL DYSTAL Study to Evaluate the Effects of RDN Using Fewer, Targeted Ablations to Achieve Meaningful Blood Pressure Reductions DUBLIN, Feb. 04, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity™ Spyral renal denervation (RDN) system […]

Medtronic Receives CE Mark for Cobalt™ and Crome™ Portfolio of BlueSync™-Enabled Implantable Defibrillators, Cardiac Resynchronization Therapy-Defibrillators

Next Generation Technology Includes Features that Automatically Adjust to Patient Needs, and Offers Physicians Heart Failure Diagnostic Insights DUBLIN, Jan. 30, 2020 (GLOBE NEWSWIRE) —  Medtronic plc (NYSE:MDT) today announced it has received CE (Conformité Européenne) Mark for its Cobalt™ and Crome™ portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators […]

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 […]