Tag: Medtronic

Medtronic Builds on TAVR Clinical Evidence Portfolio with Five-Year CoreValve Durability Data and Complete Two-Year Outcomes in Intermediate Risk Aortic Stenosis Patients

DUBLIN and SAN DIEGO – September 24, 2018 – Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced new data presented at the 30th Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. Over the weekend, investigators presented the longest-term data to-date from […]

Medtronic Announces Clinical Study of Transcatheter Aortic Valve Replacement in Aortic Stenosis Patients with Bicuspid Valves

DUBLIN – September 18, 2018 – Medtronic plc (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a single-arm study to evaluate the CoreValve Evolut(TM)TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. […]

MEDTRONIC STATEMENT REGARDING RECENT FDA WARNING LETTERS

DUBLIN – September 11, 2018 – Today, Medtronic issued the following statement confirming it has received FDA warning letters (CMS #560736 and #562437) related to its Cardiac Rhythm and Heart Failure facilities located in Mounds View, Minn., and in Juncos, Puerto Rico. The warning letters reflect earlier FDA inspection reports from […]

Medtronic Announces One-Month DAPT Clinical Study in the U.S. and Japan with Resolute Onyx DES in High Bleeding Risk Patients

(GLOBE NEWSWIRE via COMTEX) —The Onyx ONE Clear Study Builds Upon Body of Clinical Evidence to Inform Individualized DAPT Duration Following Stent Procedures DUBLIN – September 10, 2018 – Medtronic plc (NYSE:MDT) today announced the start of the Onyx ONE Clear Study in the U.S. and Japan that will evaluate one-month […]

Medtronic EVP & CFO Karen L. Parkhill to Speak at Morgan Stanley Global Healthcare Conference

(GLOBE NEWSWIRE via COMTEX) –DUBLIN – September 4, 2018 – Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it will participate in the Morgan Stanley 16th Annual Global Healthcare Conference on Friday, September 14, 2018, in New York City. Karen Parkhill, executive vice president and chief financial officer […]

Study Shows Improved Quality of Life and Reduced Symptoms In Patients Treated with Medtronic Cryoballoon

DUBLIN and MUNICH – August 28, 2018 – Medtronic plc (NYSE:MDT) today announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life, reduced symptoms from abnormal heart rhythms, and low incidence of reinterventions and repeat ablation procedures. The study evaluated patients with symptomatic persistent atrial fibrillation (AF) […]

Medtronic Receives FDA Approval for Implantable System for Remodulin® to Treat Patients with Pulmonary Arterial Hypertension

DUBLIN – July 31, 2018 – Medtronic plc (NYSE:MDT) has received U.S. Food and Drug Administration (FDA) approval for the Implantable System for Remodulin® (ISR) to treat patients with pulmonary arterial hypertension (PAH). Through a first-of-its-kind collaboration, the Medtronic SynchroMed(TM) II drug delivery system and cardiac catheter technologies were leveraged to […]

Medtronic to Provide Public Comment During CMS Committee Meeting on Volume Requirements for Transcatheter Aortic Valve Replacement (TAVR)

DUBLIN and BALTIMORE – July 25, 2018 – Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, will deliver public comment during the Centers for Medicare & Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting on July 25, which will assess whether scientific evidence supports requiring […]

Medtronic Clinical Trial to Evaluate ECG Belt for Optimizing Heart Failure Therapy

DUBLIN – July 19, 2018 – Medtronic plc (NYSE: MDT) today announced first enrollments in a new clinical trial evaluating the ECG (electrocardiography) Belt Research System (ECG Belt) as a diagnostic tool for optimizing cardiac resynchronization therapy (CRT) for patients with heart failure. The first patient enrolled in the ECG Belt for […]