SAN DIEGO, September 28, 2022 /PRNewswire/ — REVA Medical, LLC, a leader in bioresorbable polymer technologies for vascular applications, today announced that enrollment has begun in the pivotal MOTIV trial at clinical sites in the United States and Europe. The study will evaluate the use of the MOTIV® sirolimus-eluting bioresorbable vascular scaffold for the treatment of patients suffering from chronic limb-threatening ischemia (CLTI). CLTI is an advanced stage of peripheral arterial disease (PAD), often affecting the arterial bed below the knee (BTK), and is associated with impaired quality of life due to a high risk of serious health problems, including amputation, adverse cardiovascular events and mortality.
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The MOTIV study is a worldwide 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 LCTI in a randomized comparison with standard balloon angioplasty. The study, led by co-principal investigators Dr. Ehrin Armstrong of Adventist Health in St. Helena, Californiay doctor en Medicina Andrej Schmidt de la Universitätsklinikum Leipzigwill follow 292 patients at approximately 35 clinical centers in the United States and Europe.
“The absence of an approved device as a dedicated treatment option for the approximately 20 million patients1 worldwide with CLTI is a significant unmet need,” said Dr. Jason Ricci of Bellin Health Cardiology Associates in Green Bay, Wisconsinand the physician who enrolled the first US patient. “I am delighted to play a role in this important trial and assess its potential to advance the science and therapies available for this very complex patient population.”
MOTIV is a completely bioresorbable sirolimus-eluting scaffold that is designed to dissolve over time, leaving the artery free of a permanent implant and thus 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 increased scaffold strength in a thin strut design; are intended to improve ease of use, including one-step inflation; and allow visibility of the entire device under fluoroscopy, an attribute unique to MOTIV among bioresorbable scaffolds.
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“The start of our MOTIV clinical trial is an exciting and important milestone for REVA, as well as the global medical community,” he commented. Jeffrey Anderson, President and CEO of REVA Medical, LLC. “We are focused on addressing the need for longer-lasting 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 bioabsorbable scaffold to receive CE marking for use below the knee. Dr. Schmidt, MD, recently recorded a live case using MOTIV scaffolds that was shown at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) conference. During the procedure, Dr. Schmidt, MD, implanted three 60-millimeter MOTIV scaffolds in a patient with CLTI below the knee, and the patient has demonstrated positive postoperative results.
“The MOTIV scaffold has a proven track record of positive clinical outcomes, and I am honored to have performed the first procedures with the device in this trial,” said Henrik Schröder, MD, who enrolled the first European patients in the trial in 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 in confirming 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 provided by Boston Scientific and existing investors.
Additional information can be found on the REVA website: www.revamedical.com
About REVA Medical
REVA Medical is a medical device company focused on the development and commercialization of bioabsorbable polymer technologies for vascular applications. The company’s products include MOTIV bioresorbable scaffolds for the treatment of peripheral arterial disease, Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease, and TyroSphere embolic beads. REVA is headquartered in San Diego, California. More information can be found on the REVA website: www.revamedical.com.
Fantom, Fantom Encore and MOTIV only have the CE mark. Fantom, Fantom Encore and MOTIV are available in select countries in Europe and middle East. Fantom, Fantom Encore, MOTIV, and TyroSphere are not available in the United States or other countries that do not accept the CE mark. Fantom, Fantom Encore, MOTIV, TyroSphere, and Tyrocore are trademarks of REVA Medical, LLC.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and 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, as are those statements about projections and timing surrounding business operations. and sales, clinical trials, ongoing product development, and future funding. Undue reliance should not be placed on forward-looking statements. Although management believes that forward-looking statements are reasonable when made, forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ materially from those expressed in forward-looking statements. Any forward-looking statement in this announcement speaks only as of the date it is made. REVA undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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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