Feature | April 24, 2015

Minneapolis Heart Institute Foundation Conducts First U.S. Implant of TMVR Device

Procedure part of global FDA early feasibility study under Investigational Device Exemption

Minneapolis Heart Institute Foundation, TMVR, Tendyne, FDA, first implant, U.S.

April 24, 2015 — Minneapolis Heart Institute Foundation (MHIF) physicians are conducting a research study using the first transcatheter mitral valve replacement (TMVR) in the United States at Minneapolis Heart Institute at Abbott Northwestern Hospital.

Wes Pedersen, M.D., 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 Robert Saeid Farivar, M.D., Ph.D., chief cardiothoracic surgeon and co-principal investigator in the study.

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 U.S. Food and Drug Administration (FDA) issued guidance on Investigational Device Exemptions (IDEs) 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. 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.”

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.

For more information: www.mplsheart.org

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init