Press Releases | Medtronic

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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...
May 1, 2019

Medtronic Receives FDA Approval for World's First Quadripolar Active Fixation Left Heart Lead

Attain Stability(TM) Quad MRI SureScan(TM) Lead Designed for Precise Placement and Stability

DUBLIN - May 1, 2019 - Medtronic plc (NYSE:MDT) announced it has received U.S. Food and Drug Administration (FDA) approval for the Attain Stability(TM) Quad MRI SureScan(TM) left heart lead....
Apr 17, 2019

Medtronic VenaSeal(TM) Closure System Demonstrates Durable and Consistent Outcomes at Five Years in Patients with Chronic Venous Disease

(GLOBE NEWSWIRE via COMTEX) --DUBLIN and LONDON - April 17, 2019 - Medtronic plc (NYSE:MDT) today announced five-year outcomes from the VeClose Extension Study. Nick Morrison, M.D., Center for...
Apr 8, 2019

New Data Show Encouraging Economic Outcomes for Medtronic HeartWare(TM) HVAD(TM) System

Positive HVAD LATERALTM Study Results Also Now Published in The Journal of Heart and Lung Transplantation

DUBLIN and ORLANDO, Fla. - April 8, 2019 - Medtronic plc (NYSE:MDT) today announced data showing promising economic outcomes for the Medtronic HeartWare(TM) HVAD(TM) System after analyzing...
Apr 7, 2019

Medtronic Data Expands on Key Aortic Solutions for Challenging Anatomies

(GLOBE NEWSWIRE via COMTEX) --New EndoSuture Aneurysm Repair (ESAR) and Valiant Navion(TM) Data Presented at Charing Cross Demonstrate Safety and Efficacy in Patients with Complex Anatomies DUBLIN...
Apr 5, 2019

Medtronic HeartWare(TM) HVAD(TM) System Demonstrates Reduction in Total Strokes, Disabling Strokes and Stroke-Related Mortality with Blood Pressure Management

Company Has Initiated a Post-Approval Study of Heart Failure Management Best Practices to Further Demonstrate Improved Patient Outcomes

DUBLIN and ORLANDO, Fla. - April 5, 2019 - Medtronic plc (NYSE:MDT) today announced the results of an analysis on the impact of stroke severity in patients receiving its HeartWare(TM) HVAD(TM)...
Mar 17, 2019

New Clinical Trial Shows Medtronic TYRX(TM) Envelope Significantly Reduces Major Infections in Cardiac Implantable Device Patients

Late-Breaking Trial Results Presented at ACC Scientific Sessions and Published in The New England Journal of Medicine

DUBLIN and NEW ORLEANS - March 17, 2019 - Medtronic plc (NYSE:MDT) today announced results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), which...
Mar 16, 2019

Medtronic Evolut Low Risk Trial Meets Primary Endpoint

Less Invasive Evolut™ Transcatheter Aortic Valve Replacement (TAVR) System Successful in Clinical Trial When Compared to Open Heart Surgery in Healthier Aortic Stenosis Patients

DUBLIN and NEW ORLEANS – March 16, 2019 – Medtronic plc (NYSE:MDT) today announced first-ever clinical data from the landmark Evolut Low Risk Trial comparing the minimally invasive Evolut™...
Mar 1, 2019

Medtronic Statement Regarding IN.PACT Paclitaxel Safety Analysis Correction Letter in The Journal of the American College of Cardiology

DUBLIN - March 1, 2019 - On February 15, 2019, Medtronic issued a statement regarding a programming error in the clinical data reporting isolated to the two and three year follow-up periods in our...
Feb 26, 2019

Medtronic Resolute(TM) Drug-Eluting Stent (DES) Platform Receives Expanded Indication for Treatment of Chronic Total Occlusion (CTO)

FDA Approval Allows Interventional Cardiologists Access to Resolute DES Technology to Treat De Novo CTO

DUBLIN - February 26, 2019 - Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) approval of its Resolute Drug-Eluting Stent (DES) platform (including the Resolute...
Feb 15, 2019

Medtronic Statement Regarding Revised IN.PACT Post Market Study Data

DUBLIN - February 15, 2019 - Medtronic plc (NYSE:MDT) today issued the following statement regarding revised clinical study data: Recently, Medtronic became aware of a programming error in the...
Jan 30, 2019

Medtronic Valiant(TM) Captivia(TM) Demonstrates Durability, Safety, and Efficacy at Five Years in Transection Patients

New RESCUE Trial Data Presented in Blunt Thoracic Aortic Injury

DUBLIN and SAN DIEGO - January 30, 2019 - Medtronic plc (NYSE:MDT) today announced new data supporting the long-term durability, safety, and efficacy of the Valiant(TM) Captivia(TM) thoracic stent...
Jan 24, 2019

Medtronic to Acquire EPIX Therapeutics, Expanding Its Cardiac Ablation Portfolio

(GLOBE NEWSWIRE via COMTEX) --DiamondTemp Ablation System Represents Disruptive RF Innovation DUBLIN - January 24, 2019 - Medtronic plc (NYSE: MDT) today announced that it has entered into a...
Jan 22, 2019

Patient-Level Survival Analysis Demonstrates No Link Between Paclitaxel Dose and Mortality in Patients Treated with IN.PACT Admiral DCB

Data Presented Today at LINC Reiterate Commitment to Patient Safety and Data Transparency

DUBLIN and LEIPZIG, Germany - January 22, 2019 - Medtronic plc (NYSE:MDT) today announced new data shared on the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in patients with peripheral...
Jan 15, 2019

Medtronic Launches Mobile App That Communicates Directly with World's First Smartphone-Connected Pacemakers

MyCareLink Heart(TM) Mobile App Allows Pacemaker Patients to Easily Stay Connected with Their Clinics

DUBLIN - January 15, 2019 - Medtronic plc (NYSE:MDT) today announced the launch of its MyCareLink Heart(TM) mobile app to support the world's first and only portfolio of pacemakers that can...
Dec 3, 2018

Medtronic Announces First Patient Treated in TERMINATE AF Clinical Trial

Study Will Evaluate Simultaneous Use of Radiofrequency and Cryo Surgical Ablation Devices in Cardiac Surgery Patients with Atrial Fibrillation

DUBLIN - December 3, 2018 - Medtronic plc (NYSE:MDT) today announced the first patient treated in the TERMINATE AF trial, a multi-center study evaluating two surgical ablation devices - the...
Nov 16, 2018

New Findings Presented at the VEITHsymposium Reiterate Consistent, Durable Outcomes in Complex Aortic Disease with Heli-FX(TM) Endoanchor(TM) System

Three-Year Data from the ANCHOR Registry Reiterate Applicability in Patients with Hostile Aortic Neck Anatomies

DUBLIN and NEW YORK - November 16, 2018 - Medtronic plc (NYSE:MDT) today announced new data on the Heli-FX(TM) EndoAnchor(TM) system, which demonstrated durability, safety and efficacy in patients...
Nov 13, 2018

Medtronic Receives CE Mark Approval for the Valiant Navion(TM) Thoracic Stent Graft System

Lower-Profile Thoracic Endovascular Aortic Repair (TEVAR) Device Broadens Treatable Patient Population with Thoracic Aortic Disease

DUBLIN - November 13, 2018 - Medtronic plc (NYSE:MDT) today announced it has received CE Mark approval for the Valiant Navion(TM) thoracic stent graft system for the minimally invasive repair of...
Nov 8, 2018

Medtronic Begins Renal Denervation Study for High Blood Pressure Patients Prescribed Anti-Hypertensive Medication

FDA-Approved Study Furthers Medtronic Commitment to Generate Meaningful Clinical Evidence for Use of Renal Denervation to Treat Uncontrolled Hypertension

DUBLIN - November 8, 2018 - Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin a clinical trial to evaluate the Symplicity Spyral(TM) renal...
Nov 6, 2018

Medtronic Presents IN.PACT SFA Trial Five-Year Data and Total IN.PACT All-Subjects Analysis in VIVA Late Breaking Clinical Trials

(GLOBE NEWSWIRE via COMTEX) --New Data Continue to Reinforce IN.PACT Admiral DCB as a Durable, Frontline Option to Address Treatment Challenges in PAD

DUBLIN and LAS VEGAS - November 6, 2018 - Medtronic plc (NYSE:MDT) data presented today reinforce the durability, safety, and effectiveness of the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB)...
Oct 23, 2018

Medtronic Receives FDA Approval for Valiant Navion(TM) Thoracic Stent Graft System

GLOBE NEWSWIRE via COMTEX) --Next-Generation Thoracic Endovascular Repair (TEVAR) Device Expands Applicability to Broader Range of Patients DUBLIN - October 23, 2018 - Medtronic plc (NYSE:MDT)...
Sep 24, 2018

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

(GLOBE NEWSWIRE via COMTEX) --TCT18: New Five-Year Data with CoreValve TAVR System Suggests Durability Over Time, While Complete Results from the SURTAVI Trial Show Benefits of TAVR in...
Sep 21, 2018

Late-Breaking Clinical Study Results Demonstrate Exceptional Safety and Efficacy Outcomes for Resolute Onyx(TM) DES

TCT18: BIONYX Study Shows Strong Performance with Durable Polymer Resolute Onyx DES in Head-to-Head Comparison with Biodegradable Polymer DES

DUBLIN and SAN DIEGO - September 22, 2018 - Investigators today unveiled new clinical data from the physician-initiated BIONYX study, representing the first all-comers analysis in nearly 2,500...
Sep 21, 2018

Medtronic Presents IN.PACT Global Study Three-Year Data and Total IN.PACT(TM) Imaging and Propensity Analyses

Clinical Evidence Shared at TCT and CIRSE Reaffirm IN.PACT(TM) Admiral(TM) Drug-Coated Balloon as a Primary Therapy to Treat Complex, Real-World Patient Populations

SAN DIEGO and LISBON, Portugal - September 22, 2018 - Medtronic plc (NYSE:MDT) data announced today continue to reinforce the safety, durability, and consistency of the IN.PACT(TM) Admiral(TM)...
Sep 18, 2018

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

(GLOBE NEWSWIRE via COMTEX) --Medtronic Receives FDA Approval for Revised TAVR Labeling and Begins Investigational Study of Low Risk Patients with Bicuspid Valves DUBLIN - September 18, 2018 -...
Sep 10, 2018

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 -...
Aug 28, 2018

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

(GLOBE NEWSWIRE via COMTEX) --Clinical Trial Data Presented at European Society of Cardiology in Munich DUBLIN and MUNICH - August 28, 2018 - Medtronic plc (NYSE:MDT) today announced new findings...
Aug 15, 2018

Medtronic Announces Commercial Launch of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon in Japan

GLOBE NEWSWIRE via COMTEX) --DUBLIN - August 15, 2018 - Medtronic plc (NYSE:MDT) today announced full commercial launch of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) in Japan. The news...
Jul 31, 2018

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

GLOBE NEWSWIRE via COMTEX) --Medtronic SynchroMed(TM) II Pump, Proprietary Catheter Deliver United Therapeutics' Remodulin® (treprostinil) Injection DUBLIN - July 31, 2018 - Medtronic plc...
Jul 25, 2018

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

Company to Emphasize the Importance of Evidenced-Based Quality Outcomes and Appropriate Patient Access

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)...
Jul 19, 2018

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

(GLOBE NEWSWIRE via COMTEX) --DUBLIN - July 19, 2018 - Medtronic plc (NYSE: MDT) today announced first enrollments in a new clinical trial evaluating the ECG (electrocardiography) Belt Research...
Jul 12, 2018

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...
Jul 11, 2018

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

(GLOBE NEWSWIRE via COMTEX) --HeartWare(TM) HVAD(TM) System Only LVAD Approved for Implant via Thoracotomy or Median Sternotomy

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...

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