image: This is the transcatheter mitral valve replacement device under an FDA early feasibility study conducted by Minneapolis Heart Institute Foundation®. view more
Credit: Gerry Yumul @workingatheart, Minneapolis Heart Institute Foundation
MINNEAPOLIS, MINNESOTA - April 13, 2015 - Minneapolis Heart Institute Foundation® (MHIF) physicians are conducting a research study using the first transcatheter mitral valve replacement in the U.S. at Minneapolis Heart Institute® at Abbott Northwestern Hospital. Dr. Wes Pedersen, Principal Investigator in the study said, "The Tendyne Bioprosthetic Mitral Valve is designed to give implanting physicians total control because it is fully repositionable and retrievable which allows physicians to see the outcome before the procedure is closed." If proven efficacious, this may be an option for patients with diseased, damaged or malfunctioning mitral valves who are not deemed candidates for conventional surgery. "The transcatheter procedure involves implanting the replacement valve inside a beating heart without the need for open heart surgery or cardiopulmonary bypass. Through a small incision in the chest, a catheter enters the bottom of the heart and travels into the left ventricle to position the replacement valve within the natural mitral valve" said Dr. Robert Saeid Farivar, PhD, Chief Cardiothoracic Surgeon and Co-principal Investigator in the study. Jeff Franco, CEO of Tendyne Holdings, Inc. said, "We are excited that the study is taking place at Minneapolis Heart Institute at Abbott Northwestern Hospital. It is a significant milestone for Tendyne, MHIF and the physician community. Our confidence in the MHIF team is high. They are innovative world-class clinical study investigators and highly skilled in patient care. We are collaborating to clinically investigate the Tendyne TMVR device in patients that are not suitable candidates for mitral valve surgery."
Securing the research study in the U.S. this quickly, following Australian and United Kingdom studies, helps keep the United States at the forefront of emerging transcatheter valve therapy research. In September 2013 the FDA issued guidance on Investigational Device Exemptions (IDE's) for early feasibility medical device clinical studies to encourage this type of pivotal research here in the U.S. Per the FDA guidance, IDE's offer a unique opportunity to obtain clinical experience with a new or modified device or new clinical use while utilizing appropriate subject protection measures and good clinical study practices. Dr. Pedersen said, "Collaborating and learning together across research, technology and regulatory improves our ability to identify potential innovative treatments and better patient outcomes here in the U.S. This first study implant has occurred, the participant is ready for discharge and we couldn't be more thrilled."
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About the Minneapolis Heart Institute Foundation
The Minneapolis Heart Institute Foundation is dedicated to improving people's lives through the highest quality cardiovascular research and education.
- Scientific Innovation and Research -- Publishing more than 120 peer-reviewed studies each year, MHIF is a recognized research leader in the broadest range of cardiovascular medicine. Each year, cardiologists and hospitals around the world adopt MHIF protocols to save lives and improve patient care.
- Education and Outreach -- Research shows that modifying specific health behaviors can significantly reduce the risk of developing cardiovascular disease. As part of its mission, the Minneapolis Heart Institute Foundation has been involved in cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.
The Minneapolis Heart Institute Foundation is supported by Minneapolis Heart Institute at Abbott Northwestern Hospital.
About the Tendyne TMVR Device
The Tendyne TMVR is a fully retrievable and repositionable, apically tethered tri-leaflet porcine pericardial valve sewn onto a Nitinol frame that was specifically designed to address the complex mitral anatomy of functional, degenerative and mixed etiology mitral regurgitation.
About Tendyne Holdings, Inc.
Tendyne Holdings, Inc., headquartered in Roseville, MN, is a private medical device company developing a unique Transcatheter Mitral Valve Replacement. (TMVR). Implanted in a beating heart in a hybrid operating room, the Tendyne design has proprietary and patented features that can treat a variety of mitral pathologies. With a less invasive approach than open cardiac surgery. The Tendnye Bioprosthetic Mitral Valve System is an investigational device, not available for sale. All rights reserved. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.
Contact
Melissa Hanson
Minneapolis Heart Institute Foundation
P - 612-863-3628; mhanson@mhif.org
http://www.mplsheart.org