MINNEAPOLIS, May 8, 2024 /PRNewswire/ -- 4C Medical
Technologies, Inc. ("4C Medical"), a medical device company
dedicated to advancing minimally invasive therapies for structural
heart disease, has been granted Breakthrough Device designation by
the U.S. Food and Drug Administration (FDA) for the AltaValveā¢
System, a transcatheter mitral valve replacement (TMVR) device.
Among other benefits, Breakthrough Device designation expedites the
review process, shortening the time until technology reaches
patients if approved by the FDA.
Specifically, the FDA granted the AltaValve System Breakthrough
Device designations for two therapeutic indications:
- Treatment of moderate-to-severe or severe mitral regurgitation
(MR), and
- Treatment of moderate-to-severe or severe MR with
moderate/severe mitral annular calcification (MAC).
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 anatomy and comorbidities typically
present in this patient population, limited medical therapies are
available to clinicians and their patients.
"The AltaValve System offers a novel transcatheter therapeutic
option to fulfill an unmet clinical need in patients who are
unsuitable for surgery or transcatheter edge-to-edge repair. The
atrial-only fixation of the technology is designed to minimize the
complexities and variabilities associated with anchoring to the
mitral annulus," said Dr. Jeff
Chambers, Founder and Chief Medical Officer of 4C Medical.
"This differentiated approach preserves critical cardiac
structures, reducing the risk of left ventricular outflow tract
obstruction or damage to the left ventricle."
Thus far, the AltaValve has achieved favorable results in
patients who were treated in the 4C Medical's Early Feasibility
study (NCT03997305). "This data indicates that the AltaValve System
is a promising option showing high procedural success and complete
elimination of MR in most patients at 30 days," said Vlasis Ninios, M.D., interventional cardiologist
at Interbalkan Medical Center (Thessaloniki, Greece) and investigator in the
study. 4C Medical anticipates commencing a global Pivotal trial of
the AltaValve System later this year in 2024 for both indications
to support CE mark and FDA approval.
"The dual Breakthrough Designation of the AltaValve System is an
important milestone for the 4C Medical clinical program, and we are
excited to assess both indications in the upcoming the AltaValve
Pivotal trial," said Saravana Kumar,
CEO and President at 4C Medical. "This advancement enables us the
opportunity to bring this needed technology to our patients even
sooner."
The AltaValve System for TMVR is available for investigational
use only and it is not approved for use outside of clinical
studies.
About 4C Medical Technologies, Inc.
4C Medical is at
the forefront of medical device innovation, focusing on developing
transformative technologies for structural heart disease, initially
targeting mitral regurgitation (MR) therapy and subsequently
expanding to tricuspid regurgitation therapy. The AltaValve System
represents a paradigm shift in MR treatment with its atrial-only
fixation. By preserving the native mitral valve and left ventricle,
it minimizes the challenges associated with traditional
transcatheter mitral valve replacement technologies, which rely on
placement and fixation in the native mitral annulus and left
ventricle.
For more information about 4C Medical and the AltaValve System,
please visit www.4CMed.com.
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SOURCE 4C Medical Technologies, Inc.