SAN DIEGO, Sept. 27, 2022 /PRNewswire/ -- REVA Medical, LLC,
a leader in bioresorbable polymer technologies for vascular
applications, today announced that enrollment in the MOTIV pivotal
trial has been initiated at clinical centers in both the U.S. and
Europe. The study will evaluate
the use of the MOTIV® Sirolimus-Eluting Bioresorbable
Vascular Scaffold for treatment in patients suffering from chronic
limb-threatening ischemia (CLTI). CLTI is an advanced stage of
peripheral artery disease (PAD), often affecting the below-the-knee
(BTK) artery bed and associated with an impaired quality of life
due to a high risk of serious health concerns, including
amputation, adverse cardiovascular events and mortality.
The MOTIV study is a global, randomized controlled trial (RCT)
that was designed to evaluate the safety and efficacy of the MOTIV
scaffold for the treatment of infrapopliteal lesions in patients
with CLTI by randomized comparison with standard balloon
angioplasty. The study, led by co-principal investigators, Dr.
Ehrin Armstrong from Adventist
Health in St. Helena, California,
and PD Dr. med. Andrej Schmidt from
Universitätsklinikum Leipzig, will
follow up to 292 patients at approximately 35 clinical centers in
the U.S. and Europe.
"The absence of an approved device as a dedicated treatment
option for the estimated 20 million patients1 worldwide
suffering from CLTI is a significant unmet need," commented Dr.
Jason Ricci of Bellin Health
Cardiology Associates in Green Bay,
Wisconsin, and the physician who enrolled the first U.S.
patient. "I'm delighted to play a role in this important trial and
evaluate its potential to advance the science and therapies
available to this highly complex patient population."
MOTIV is a fully bioresorbable sirolimus-eluting scaffold that
is designed to dissolve over time, leaving the artery free from a
permanent implant and, thereby, allowing it to return to its
natural movement, or vasomotion. MOTIV is made from REVA's
proprietary polymer, Tyrocore®, which was developed
specifically for scaffold performance. The novel properties of
Tyrocore provide for enhanced scaffold strength in a thin-strut
design; are intended to improve ease of use, including single-step
inflation; and enable visibility of the entire device under
fluoroscopy, an attribute unique to MOTIV among bioresorbable
scaffolds.
"The initiation of our MOTIV clinical trial is an exciting and
important milestone for REVA, as well as the global medical
community," said Jeffrey Anderson,
President and CEO, REVA Medical,
LLC. "We are focused on addressing the need for more durable
treatment options for this debilitating disease and committed to
finding the best possible therapies to improve patient
outcomes."
The MOTIV scaffold has been approved for use in Europe since 2018 when the device became the
first bioresorbable scaffold to receive CE Mark for use below the
knee. PD Dr. med. Schmidt recently recorded a live case using MOTIV
scaffolds that was shown at the 2022 Transcatheter Cardiovascular
Therapeutics (TCT) conference. During the procedure, PD Dr. med.
Schimdt implanted three 60-millimeter MOTIV scaffolds in a patient
with CLTI below the knee, and the patient has demonstrated positive
post-operative results.
"The MOTIV scaffold has a demonstrated history of positive
clinical results, and I am honored to have performed the first
procedures with the device in this trial," stated Dr. med. Henrik
Schröder, who enrolled the first European patients in the trial at
Ihre Radiologien MVZ in Berlin. "The scaffold was easily
delivered, and the procedure was aided by visibility of the device
under fluoroscopy, which is beneficial to confirm proper
placement."
In August, REVA announced the closing of a $45 million Series B equity financing in support
of its clinical program for the MOTIV scaffold. That funding was
led by Boston Scientific and existing investors.
Additional information can be found at REVA's website:
www.revamedical.com
About REVA Medical
REVA Medical is a medical device company focused on the
development and commercialization of bioresorbable polymer
technologies for vascular applications. The Company's products
include MOTIV bioresorbable scaffolds for the treatment of
peripheral artery disease, Fantom and Fantom Encore bioresorbable
vascular scaffolds for the treatment of coronary artery disease,
and TyroSphere embolic beads. REVA is based in San Diego, California. More information can be
found at REVA's website: www.revamedical.com.
Fantom, Fantom Encore, and MOTIV have CE Mark only. Fantom,
Fantom Encore, and MOTIV are available in select countries in
Europe and the Middle East. Fantom, Fantom Encore, MOTIV, and
TyroSphere are not available in the U.S. or other countries that do
not accept CE Mark. Fantom, Fantom Encore, MOTIV, TyroSphere, and
Tyrocore are trademarks of REVA Medical, LLC.
Forward-Looking Statements
This announcement contains or may contain forward-looking
statements that are based on management's beliefs, assumptions, and
expectations and on information currently available to management.
All statements that are not statements of historical fact,
including those statements that address future operating plans or
performance and events or developments that may occur in the
future, are forward-looking statements, such as those statements
regarding the projections and timing surrounding commercial
operations and sales, clinical trials, pipeline product
development, and future financings. No undue reliance should be
placed on forward-looking statements. Although management believes
forward-looking statements are reasonable as and when made,
forward-looking statements are subject to a number of risks and
uncertainties that may cause actual results to vary materially from
those expressed in forward-looking statements. Any
forward-looking statements in this announcement speak only as of
the date when made. REVA does not assume any obligation to publicly
update or revise any forward-looking statements, whether as a
result of new information, future events, or otherwise.
1 ¹ Duff S, Mafilios MS, Bhounsule P, Hasegawa JT.
The burden of critical limb ischemia: a review of recent
literature.Vasc Health Risk Manag. 2019; 15:187–208. doi:
10.2147/VHRM.S209241
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