News

Medical Device Network on MSN1d
FDA approves Abbott’s TMVR system to treat mitral valve disease
The system is available for patients whose mitral valves are not working properly due to severe mitral annular calcification.
Health and Me on MSN1d
New Mitral Valve Replacement Device Wins FDA Approval
The Tendyne system is designated for those who are at high risk for traditional open-heart surgery. It helps with those with ...
Healio1d
FDA approves transcatheter mitral valve replacement system for high surgical risk patients
Abbott announced the FDA approved its transcatheter mitral valve replacement system for patients with severe mitral annular ...
TCTMD1d
Tendyne Approved in US for High-risk Patients With Mitral Valve Disease
The approval is tightly defined: the system will be for patients ineligible for surgery and with anatomy unfavorable for TEER ...
MassDevice2d
FDA approves Abbott mitral valve replacement device that doesn’t require open-heart surgery
Abbott (NYSE: ABT) announced today that it received FDA approval for its Tendyne transcatheter mitral valve replacement (TMVR ...
Pharmabiz14h
US FDA approves Abbott’s Tendyne, first-of-its-kind device to replace the mitral valve without open-heart surgery
US FDA approves Abbott’s Tendyne, first-of-its-kind device to replace the mitral valve without open-heart surgery: Abbott Park, Illinois Thursday, May 29, 2025, 16:00 Hrs [IST] ...
Crain's Chicago Business2d
Abbott wins approval for open-heart surgery-free valve replacement
The FDA gave the OK for the North Chicago-based medical device maker's Tendyne transcatheter mitral valve replacement.
MedPage Today on MSN2d
Tendyne TMVR Gets FDA Nod; Breastfeeding and ASCVD; Sudden Bodybuilder Deaths
Abbott's Tendyne transcatheter mitral valve replacement (TMVR) system was approved by the FDA and indicated for those with ...
Abbott wins FDA approval for mitral valve replacement device, teeing up Edwards competition
Abbott said the Tendyne system addresses a significant unmet need in cardiac care, providing an option for patients ineligible for open heart surgery and whose valves cannot be successfully repaired ...
Fierce Biotech2d
Abbott snags US approval for Tendyne mitral valve replacement implant
The FDA approved Abbott's Tendyne minimally invasive heart replacement for mitral valve disease that could disqualify ...
Morningstar2d
Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery
"Mitral annular calcification stiffens the structure of the mitral valve and can lead to mitral regurgitation or stenosis that disrupt the heart's ability to pump blood effectively. These ...