Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the hearts upper right chamber causing eventual heart failure or death. The study begins on the heels of a recent Breakthrough Device Designation issued by the FDA for the Intrepid TTVR System. The Intrepid TTVR system is an investigational device worldwide.
Were beginning a new journey that we believe will open the door for the potential future treatment of patients with tricuspid valve regurgitation, who constitute a significant, patient population suffering from heart valve disease today, said Azeem Latib, M.D., section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York City and co-principal investigator in the study. There has been much progress regarding transcatheter replacement of diseased aortic valves, but whether we can replace the tricuspid valve without open heart surgery represents a new frontier in cardiology.
Representing a large, unmet clinical need, tricuspid regurgitation affects more than 2 million patients in the United States. It is a highly undertreated disease due to the morbidity and mortality associated with surgical intervention.
Medtronic recently received Breakthrough Device Designation by the FDA for the Intrepid TTVR system. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right heart functions and are higher risk due to co-morbidities, said Vinayak (Vinnie) Bapat, M.D., chief of cardiothoracic surgery at the Minneapolis Heart Institute and co-principal investigator in the study. We are optimistic that these early learnings will help fuel additional clinical research and device innovation around this treatable disease.
The Intrepid transcatheter valve is the same valve being evaluated for the treatment of symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study. The device is implanted using a transfemoral delivery catheter, which assists physicians in delivering and placing the valve through a catheter inserted in the femoral vein.
- Interventional Cardiology Fellowship - Massachusetts General Hospital ... - April 8th, 2018 [April 8th, 2018]
- Dr. Eric Lo - Daytona Beach FL, Interventional Cardiology - April 18th, 2018 [April 18th, 2018]
- Interventional Cardiology | Cardiology Associates of East ... - April 19th, 2018 [April 19th, 2018]
- ECU Interventional Cardiology Fellowship - May 26th, 2018 [May 26th, 2018]
- Interventional Cardiology | Knoxville Heart Group - June 6th, 2018 [June 6th, 2018]
- Interventional Cardiology Fellowship - Massachusetts ... - June 14th, 2018 [June 14th, 2018]
- Scottsdale Interventional Forum | Cardiology Conference ... - June 21st, 2018 [June 21st, 2018]
- Interventional Cardiology - Terumo Europe - August 12th, 2018 [August 12th, 2018]
- Interventional Cardiology Fellowship | Cardiovascular Fellowship - September 20th, 2018 [September 20th, 2018]
- Interventional > Cardiovascular Medicine | Internal Medicine ... - September 20th, 2018 [September 20th, 2018]
- Interventional Cardiology Journal | Peer reviewed Journal - September 24th, 2018 [September 24th, 2018]
- Interventional Cardiology | North Florida Regional Medical ... - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Department of Medicine ... - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Medical City Fort Worth - October 4th, 2018 [October 4th, 2018]
- Cardiology and Interventional Cardiology | Texas Tech ... - October 4th, 2018 [October 4th, 2018]
- Invasive & Interventional Cardiology Section | Cleveland Clinic - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology - Crozer-Keystone Health System - PA - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology - Florida Medical Clinic - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | Heart Hospital of New Mexico - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology | ColumbiaDoctors - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiologist Jobs | Glassdoor - October 4th, 2018 [October 4th, 2018]
- What are Invasive, Non-Invasive, and Interventional Cardiology? - October 4th, 2018 [October 4th, 2018]
- Interventional Cardiology Fellowship | Internal Medicine - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Community Health Network - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Ohio State Medical Center - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology | Stanford Health Care - October 25th, 2018 [October 25th, 2018]
- Interventional Cardiology - Montefiore Medical Center - November 10th, 2018 [November 10th, 2018]
- Interventional Cardiologists near Brooklyn, NY - Healthgrades - November 10th, 2018 [November 10th, 2018]
- Cardiac Catheterization | Interventional Cardiology in New ... - November 20th, 2018 [November 20th, 2018]
- What are Invasive, Non-Invasive, and Interventional ... - November 27th, 2018 [November 27th, 2018]
- Dr. Jaffar A Raza - Secaucus NJ, Interventional Cardiology - November 30th, 2018 [November 30th, 2018]
- Interventional cardiology - Wikipedia - December 13th, 2018 [December 13th, 2018]
- Interventional Cardiology | St. Francis - December 21st, 2018 [December 21st, 2018]
- Interventional Cardiologists near Secaucus, NJ - Healthgrades - December 21st, 2018 [December 21st, 2018]
- Interventional Cardiology Conferences & Meetings - December 25th, 2018 [December 25th, 2018]
- Interventional Cardiology - Baylor Heart and Vascular Hospital - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiology - nationwidechildrens.org - January 18th, 2019 [January 18th, 2019]
- General & Interventional Cardiology - WakeMed - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiology - University of Mississippi Medical ... - January 18th, 2019 [January 18th, 2019]
- Interventional Cardiologists in Austin, TX | Austin Heart - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Sutter Health - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology - St. Mary's Hospital and Health ... - February 22nd, 2019 [February 22nd, 2019]
- London & Milan - Cardiology Fellowships - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Saint Luke's Health System - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | American Medical Association - February 22nd, 2019 [February 22nd, 2019]
- Interventional Cardiology | Piedmont Heart Institute ... - March 12th, 2019 [March 12th, 2019]
- Interventional Cardiology | UCSF Cardiology - March 18th, 2019 [March 18th, 2019]
- If You Are Referred to an Interventional Cardiologist - April 1st, 2019 [April 1st, 2019]
- Cardiology and Interventional Medicine | Veterinary ... - April 5th, 2019 [April 5th, 2019]
- Interventional Cardiology | AdventHealth Cardiovascular ... - May 11th, 2019 [May 11th, 2019]
- APSIC - Asian Pacific Society of Interventional Cardiology - May 13th, 2019 [May 13th, 2019]
- Interventional Cardiology | UNC REX Healthcare | Raleigh ... - May 20th, 2019 [May 20th, 2019]
- Interventional Cardiology - montefiore.org - May 20th, 2019 [May 20th, 2019]
- Women and heart health: Heart attack signs and symptoms to know about - The Indian Express - September 26th, 2019 [September 26th, 2019]
- Tiara for Treatment of Mitral Regurgitation and Neovasc Reducer for Treatment of Refractory Angina to be Featured at TCT 2019 Conference - Canada... - September 26th, 2019 [September 26th, 2019]
- TherOx to Present on SuperSaturated Oxygen (SSO2) at TCT2019 Next Week - BioSpace - September 26th, 2019 [September 26th, 2019]
- Too tired? it can indicate heart failure - The New Indian Express - September 26th, 2019 [September 26th, 2019]
- Blue Sail Medical and Biosensors International enter the Structural Heart market with the acquisition of Switzerland based NVT AG. content= - PR... - September 26th, 2019 [September 26th, 2019]
- Global Diagnostic Interventional Cardiology Instruments Market forecast by 2025 : Numerous tactics accepted by industry participants in a bid to... - September 26th, 2019 [September 26th, 2019]
- UMA's Complete Conference Management Hosts "Full Spectrum of Heart Failure Therapy: Optimizing Outcomes" - Yahoo Finance - September 26th, 2019 [September 26th, 2019]
- Meet the best cardiologists at King's Interactive Heart Health Morning - Gulf News - September 26th, 2019 [September 26th, 2019]
- Lights, camera, action in Varnville - Bluffton Today - September 26th, 2019 [September 26th, 2019]
- Health Pro: Cardiologist takes pleasure in getting patients back on their feet - Florida Today - September 26th, 2019 [September 26th, 2019]
- From Ceiling Suspension to Eye-Tracking: Innovation Continues for Cath Lab Radiation Protection - TCTMD - September 26th, 2019 [September 26th, 2019]
- Robocath Successfully Carries Out Its First Robotic Coronary Angioplasties in Humans - TCTMD - September 26th, 2019 [September 26th, 2019]
- SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in ABIOMED, Inc. of Class Action Lawsuit and Upcoming... - September 28th, 2019 [September 28th, 2019]
- Study links childhood obesity with screen time - The Hindu - September 28th, 2019 [September 28th, 2019]
- Tiara for Treatment of Mitral Regurgitation and Neovasc Reducer for Treatment of Refractory Angina to be Featured at TCT 2019 Conference - BioSpace - September 28th, 2019 [September 28th, 2019]
- Five Atlantic Health System Team Members Lauded by NJ American Heart Association for Life-Saving Measures - TAPinto.net - September 28th, 2019 [September 28th, 2019]
- World Heart Day 2019: Cardiovascular Disease Is The World's Biggest Killer And Claims More Than 17.5 Million Lives - Outlook India - September 28th, 2019 [September 28th, 2019]
- Consulting Cardiologists Brings Exceptional Care to Heart of WH - Patch.com - September 28th, 2019 [September 28th, 2019]
- Diagnostic Interventional Cardiology Devices Market 2019| Global Forecast to 2026 with Key Players- B. Braun Medical, Boston Scientific, Cook Medical,... - September 28th, 2019 [September 28th, 2019]
- Surmodics Inc. (SRDX) and Its Competitors Comparing side by side. - MS Wkly - October 17th, 2019 [October 17th, 2019]
- Global Price, Sales and Revenue Analysis of Diagnostic Interventional Cardiology Devices Market by Regions, Manufacturers, Types and Applications -... - October 17th, 2019 [October 17th, 2019]
- Global Interventional Cardiology Devices Market Study by Price, Type and Application, Statistical Forecast and Competitive Landscape Research upto... - October 17th, 2019 [October 17th, 2019]
- Global Interventional Cardiology Market Report, Trends, CAGR Standing, Analysis and Forecasts (2019-2025) | Key Companies BIOTRONIK SE & Co.... - October 17th, 2019 [October 17th, 2019]
- Interventional Cardiology Market 2019 to Flourish with an Impressive CAGR of XX% in the year 2024, Predicts Market Research Future According to... - October 17th, 2019 [October 17th, 2019]
- FDA Approves Coronary ViperWire Advance With Flex Tip - Diagnostic and Interventional Cardiology - October 23rd, 2019 [October 23rd, 2019]
- Teleflex Announces Third Quarter 2019 Earnings Conference Call Information Live Webcast is scheduled at 8:00 am (ET) on Thursday, October 31, 2019 -... - October 23rd, 2019 [October 23rd, 2019]
- Global Interventional Cardiology Devices Market Analysis and CAGR during the Forecasting years of 2019-2025. - Air News Paper - October 23rd, 2019 [October 23rd, 2019]