York County Medicine Winter 2020 - 10

YO R K C O M E D S O C . O R G

FEATURE:

UPMC First in Central Pennsylvania
to Participate in New Study
of Less Invasive Approach
to Treating Patients with
Severe Mitral Regurgitation
Early Feasibility Study of the Transcatheter Mitral Valve Repair (TMVR)
Transseptal System Now Underway at UPMC Pinnacle
HARRISBURG, Pa. (Sept. 1, 2020) - UPMC today announced
it is the first health system in central Pennsylvania and second in
the U.S. to treat a patient as part of a study evaluating the safety
and performance of a new system for those patients ineligible for
conventional mitral valve surgery. The Early Feasibility Study of
the TMVR Transseptal System is designed to evaluate transseptal/
transfemoral access of the Intrepid™ TMVR system in patients
with severe, symptomatic mitral valve regurgitation.
The first patient treated at UPMC Pinnacle Harrisburg was
implanted by the team of Hemal Gada, M.D., medical director
of structural heart and interventional cardiologist; Mubashir
Mumtaz, M.D., F.A.C.S., F.A.C.C., chief of cardiothoracic surgery
and surgical director of structural heart; and Amit Vora, M.D.,
M.P.H., associate director of the structural heart program.
" UPMC Heart and Vascular Institute remains at the forefront
of participating in the early phases of clinical trials for promising
less-invasive therapies to address the need for better heart failure
treatment, " said Dr. Gada. " Clinical trials like this one give our
patients access to new treatments and keep our heart and vascular
team attuned to the latest research and therapeutics. We are
hopeful that the TMVR Transseptal system will provide a new,
less invasive way to treat this patient population, of which a large
proportion are considered too high risk for surgery. "

Mitral regurgitation occurs when blood flows backward
through the mitral valve and into the atrium each time the left
ventricle contracts. If left untreated, mitral regurgitation can lead
to heart failure or death. Due to the complexity of the mitral valve
anatomic structure and multiple comorbidities typically present in
such patients, limited medical therapies are available to clinicians
and their patients.
The Intrepid™ TMVR system integrates self-expanding, dualstent technology with a replacement tissue heart valve to facilitate
a catheter-based implantation. The Intrepid™ valve is compressed
inside a hollow delivery catheter which is guided through the
femoral vessel and across the septum of the heart to reach the
mitral valve. The new replacement valve is expanded directly into
the malfunctioning mitral valve. The outer stent frame is designed
to attach and conform to the native valve without the need for
additional sutures, tethers, or anchors to secure the prosthesis. The
inner stent houses the valve, which is made from bovine tissue and
is intended to maintain blood flow.
The Early Feasibility Study of the TMVR Transseptal System
will enroll and treat up to 15 patients within the United States
with severe, symptomatic mitral regurgitation. The primary
objective is to evaluate the safety of the implant and delivery
system, with secondary objectives measuring quality of life and
valve performance.
The Intrepid™ TMVR system is available for investigational
use only and it is not approved for use outside of clinical studies.

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York County Medicine | W I N T E R 2020/2021


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York County Medicine Winter 2020

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