Tag: Medtronic

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 […]

Medtronic Wins Expanded Indication for SelectSecure(TM) MRI SureScan(TM) Pacing Lead for His Bundle Site Stimulation

(GLOBE NEWSWIRE via COMTEX) –DUBLIN – July 12, 2018 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) labeling expansion for the Medtronic SelectSecure(TM) MRI SureScan(TM) Model 3830 cardiac pacing lead to include stimulation of the bundle of His. It is the only pacing lead on the market […]

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure

DUBLIN – July 11, 2018 – Medtronic plc (NYSE: MDT) has received United States Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD(TM) System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The HVAD System is the smallest commercially available LVAD, and […]

Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value

NEW YORK CITY – June 5, 2018 – Medtronic plc (NYSE: MDT) today is presenting its strategic roadmap and outlining its long-range plan for creating shareholder value at the 2018 Medtronic Institutional Investor and Analyst Day in New York City. The company is unveiling its pipeline across multiple businesses, asserting its […]

FDA Classifies HeartWare(TM) HVAD(TM) Systems Unexpected Power Source Switching as Class I Recall

DUBLIN – June 1, 2018 – The United States Food and Drug Administration (FDA) has classified Medtronic plc’s (NYSE: MDT) recent voluntary urgent field action related to the HeartWare(TM) HVAD(TM) System unexpected power source switching as a Class I recall. Class I recalls describe situations where there is reasonable risk of […]

Independent Stent Imaging Study Shows Excellent Healing Profile with Resolute Onyx DES in Complex Patients with Coronary Artery Disease

DUBLIN and PARIS- May 24, 2018 – Investigators today unveiled clinical data from the independently run Onyx 1-Month OCT Study, which showed strong early vessel healing in a patient population that contained a high percentage of patients with complex coronary artery disease who were implanted with the Resolute Onyx(TM) DES at […]