Transfemoral access added into landmark APOLLO Pivotal Trial
following IDE approval from FDA
DUBLIN and ORLANDO, Fla., Nov. 6,
2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global
leader in healthcare technology, today presented early data for its
self-expanding Intrepid™ transcatheter mitral valve
replacement (TMVR) system in patients with severe, symptomatic
mitral valve regurgitation (MR) utilizing the transfemoral access
route. Presented as Late-Breaking Clinical Science at the 33rd
Transcatheter Cardiovascular Therapeutics (TCT) conference, the
annual scientific symposium of the Cardiovascular Research
Foundation, data from the first 15 patients enrolled in an
Early Feasibility Study of the Intrepid Transfemoral System showed
100% survival and no stroke, a median procedure time of 46 minutes,
and none/trace MR in all implanted patients at 30 days. The data
were published simultaneously in the Journal of the American
College of Cardiology (JACC): Cardiovascular Intervention.
"These data indicate that the new Intrepid Transfemoral Delivery
System is a promising option for the delivery of the Intrepid valve
with all patients in the study showing almost complete elimination
of MR at 30 days," said Firas Zahr,
M.D., interventional cardiologist and co-director of the Complex
Heart Valve Program at Oregon Health and Science University and
investigator in the study. "The addition of transfemoral access
into the Apollo Trial will provide study investigators with an
access route that could present less risk to patients during the
procedure."
Mitral regurgitation (MR) occurs when blood flows backward
through the mitral valve and into the atrium each time the left
ventricle contracts. If left untreated, MR 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 valve has been used to treat more than 350 patients
as part of global clinical trials. Currently, the Medtronic APOLLO
Trial is evaluating the Intrepid TMVR system in patients with
severe MR with one cohort evaluating patients with primary or
secondary MR who are unsuitable for conventional mitral valve
surgery or transcatheter edge-to-edge repair (TEER). A second
cohort is evaluating patients with severe symptomatic MR who are
deemed ineligible for conventional mitral valve surgery with mitral
annular calcification (MAC). To date, patients enrolled in the
study have received the Intrepid TMVR system using the transapical
access route where the valve is compressed inside a hollow catheter
and inserted between the ribs into the heart. With IDE approval,
APOLLO study investigators will now have the additional option to
insert the valve via an incision in the groin into the femoral
vein, which has historically been the preferred approach for most
transcatheter procedures.
The Intrepid TMVR system, which received Breakthrough Device
Designation from FDA (for patients unsuitable for transcatheter
edge-to-edge repair or mitral valve surgery), integrates
self-expanding, dual-stent technology with a replacement tissue
heart valve to facilitate a catheter-based implantation. Using a
delivery catheter to insert the valve into the heart, 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 development of the Intrepid Transfemoral Delivery System is
an important milestone for the Intrepid TMVR program and we are
excited to introduce it into the Apollo Trial," said Nina Goodheart, senior vice president and
president of the Structural Heart & Aortic business, which is
part of the Cardiovascular Portfolio at Medtronic. "We believe this
advancement will expand our clinical trial offerings to more
patients."
The Intrepid TMVR system is available for investigational use
only and it is not approved for use outside of clinical
studies.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global
healthcare technology company that boldly attacks the most
challenging health problems facing humanity by searching out and
finding solutions. Our Mission — to alleviate pain, restore health,
and extend life — unites a global team of 90,000+ passionate people
across 150 countries. Our technologies and therapies treat 70
health conditions and include cardiac devices, surgical robotics,
insulin pumps, surgical tools, patient monitoring systems, and
more. Powered by our diverse knowledge, insatiable curiosity, and
desire to help all those who need it, we deliver innovative
technologies that transform the lives of two people every second,
every hour, every day. Expect more from us as we empower
insight-driven care, experiences that put people first, and better
outcomes for all. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE:MDT), visit
www.Medtronic.com and follow @Medtronic on Twitter and
LinkedIn.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated
results.
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SOURCE Medtronic plc