Press Releases | Medtronic

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Nov 21, 2019

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...
Nov 11, 2019

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 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study showing that an...
Nov 5, 2019

Four-Year Data from the IN.PACT Global Study Highlight Durable Performance and Safety of IN.PACT™ Admiral™ DCB

Longest-Term Data from a Real-World PAD Patient Population Presented at VIVA

DUBLIN and LAS VEGAS, Nov. 05, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced four-year data from the IN.PACT Global study, which reinforce the long-term durability and safety...
Oct 31, 2019

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™...
Oct 29, 2019

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...
Oct 9, 2019

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...
Oct 8, 2019

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...
Oct 7, 2019

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...
Sep 27, 2019

Medtronic Announces Early Feasibility Trial for Intrepid™ Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal Approach

New Study Shows Momentum in Establishing a Less Invasive Approach to Treat Patients with Severe Mitral Valve Disease

DUBLIN, Sept. 27, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced it has received U.S. Food and Drug Administration (FDA) approval to begin an early feasibility study (EFS) for...
Sep 26, 2019

Resolute Onyx™ DES Meets Primary Endpoint in First-Ever Clinical Study Comparing Drug-Eluting Stents in High-Bleeding Risk (HBR) Patients with One-Month DAPT

TCT19: First Results from Onyx ONE Global Study Also Show Superior Acute Performance and Build Upon Robust Clinical Evidence for Resolute Onyx with Shortened DAPT

DUBLIN and SAN FRANCISCO, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) announced today late-breaking clinical data from the Onyx ONE Global Study, representing the first...
Sep 23, 2019

Medtronic Announces FDA Approval and U.S. Launch of Next-Generation Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients

Improved Functionality Across Four Valve Sizes and Lowest Delivery Profile on the Market, the Evolut PRO+ TAVR System Launches in U.S. as TAVR Patient Population Grows

DUBLIN, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of...
Sep 14, 2019

IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints

IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients

DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational...
Aug 29, 2019

Medtronic EVP & CVG President Mike Coyle to Speak at Wells Fargo Securities Healthcare Conference

DUBLIN, Aug. 29, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that it will participate in the 14th Annual Wells Fargo Securities...
Aug 16, 2019

Medtronic Evolut TAVR System Receives Expanded Indication to Treat Symptomatic Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

Expanded TAVR Indication to Younger, More Active Patients Signals Groundbreaking Shift in the Future Treatment of Heart Valve Disease

DUBLIN, Aug. 16, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Evolut™ Transcatheter Aortic Valve Replacement (TAVR)...
Aug 7, 2019

Medtronic Statement Regarding Updated FDA Letter To Healthcare Providers On Paclitaxel Devices to Treat Peripheral Artery Disease

DUBLIN – August 7, 2019 – Medtronic plc (NYSE:MDT) today issued the following statement regarding the U.S. Food and Drug Administration's (FDA) updated Letter to Healthcare Providers for...
Jul 8, 2019

Medtronic HeartWare(TM) HVAD(TM) Implanted via Less Invasive Thoracotomy Shows 95 Percent Freedom from Disabling Stroke at Two Years

Company Plans Global Registry of HVAD Thoracotomy Implants to Advance Therapy Knowledge

DUBLIN, July 08, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced two-year outcomes from the LATERAL clinical trial evaluating the use of its HeartWare™ HVAD™ System in...
Jun 21, 2019

Medtronic Supports CMS Ruling on TAVR National Coverage Determination

DUBLIN - June 21, 2019 - Medtronic plc (NYSE:MDT) today issued the following statement regarding the final decision memo updating the TAVR National Coverage Determination (NCD) 20.32 announced by...
Jun 20, 2019

Medtronic Statement Regarding FDA Circulatory System Devices Panel

DUBLIN - June 20, 2019 - Medtronic plc (NYSE:MDT) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices...
May 29, 2019

Medtronic Gains U.S. FDA Clearance for New Catheter System for HIS Bundle Pacing

DUBLIN - May 29, 2019 - Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) clearance and commercial launch for the SelectSite(TM) C304-HIS deflectable catheter system...
May 28, 2019

Medtronic EVP & CVG President Mike Coyle to Speak at Jefferies 2019 Global Healthcare Conference

DUBLIN - May 28, 2019 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it will participate in the Jefferies 2019 Global Healthcare Conference on Wednesday, June...
May 22, 2019

Results Announced from Two Renal Denervation Studies at EuroPCR Show Positive Outcomes in High-Risk Hypertensive Patients

Results Announced from Two Renal Denervation Studies at EuroPCR Show Positive Outcomes in High-Risk Hypertensive Patients
May 16, 2019

Medtronic Launches Telescope(TM) Guide Extension Catheter to Support Complex Coronary Cases

FDA Cleared and CE Marked, Telescope Enters Global Market with Design Innovations to Enable Smooth Delivery of Coronary Stents and Balloons

DUBLIN - May 16, 2019 - Medtronic plc (NYSE:MDT), a global leader in percutaneous coronary intervention (PCI) innovation, today announced its entrance into the guide extension catheter market with...
May 11, 2019

Medtronic Reveals Results of First-In-Human Study for Investigational Extravascular ICD System

Company to Proceed with Plans for Future Pivotal Study of New ICD System

DUBLIN and SAN FRANCISCO – May 11, 2019 – Medtronic plc (NYSE:MDT) today announced findings from a pilot study of its investigational Extravascular Implantable Cardioverter Defibrillator (EV...
May 10, 2019

New Studies Highlight Underuse of Implantable Cardiac Devices

Treatment Disparities Prevent Indicated Patients from Receiving Evidence-Recommended Life-Saving Devices

DUBLIN and SAN FRANCISCO - May 10, 2019 - Three new studies show that patients who are medically indicated for implantable heart devices, including implantable cardioverter defibrillators (ICDs)...
May 2, 2019

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

Tablet-Based Device Manager Provides Portable and Secure Wireless Programming of Medtronic BlueSync(TM) Devices

DUBLIN - May 2, 2019 - Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With...

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