Press Release

Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation
"We're 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
Representing a large, unmet clinical need, tricuspid regurgitation affects more than 2 million patients in
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
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.
About Medtronic
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
Contacts: |
|
Joey Lomicky |
|
Public Relations |
Investor Relations |
+1-763-381-1204 |
+1-763-505-4626 |
View original content to download multimedia:http://www.prnewswire.com/news-releases/medtronic-receives-breakthrough-device-designation-from-fda-begins-early-feasibility-study-for-investigational-intrepid-transcatheter-valve-system-for-the-treatment-of-tricuspid-valve-regurgitation-301124531.html
SOURCE