Reva Medical Begins Enrollment in the MOTIV IDE Clinical Trial

September 27, 2022—Reva Medical, LLC, announced that enrollment in the MOTIV pivotal trial has been initiated at clinical centers in the United States and Europe. The study, which is being conducted under an FDA investigational device exemption (IDE), will evaluate the use of the company’s Motiv sirolimus-eluting bioresorbable vascular scaffold for treatment in patients with chronic limb-threatening ischemia (CLTI).

According to the company, the MOTIV study is a global, randomized controlled trial designed to evaluate the safety and efficacy of the Motiv scaffold compared to standard balloon angioplasty for the treatment of infrapopliteal lesions in patients with CLTI. The study will enroll up to 292 patients at approximately 35 clinical centers in the United States and Europe.

MOTIV is being led by Coprincipal Investigators Ehrin Armstrong, MD, from Adventist Health in St. Helena, California, and Professor Andrej Schmidt, MD, from Universitätsklinikum Leipzig in Leipzig, Germany.

The company noted that Prof. Schmidt recently recorded a live case using Motiv scaffolds that was shown at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts. During the procedure, Prof. Schmidt implanted three 60-mm Motiv scaffolds in a patient with CLTI below the knee; the patient has demonstrated positive postoperative results.

Jason Ricci, MD, of Bellin Health Cardiology Associates in Green Bay, Wisconsin, enrolled the first United States patient in the study.

Dr. Ricci commented in Reva Medical’s press release, “The absence of an approved device as a dedicated treatment option for the estimated 20 million patients worldwide suffering from CLTI is a significant unmet need. 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.”

Henrik Schröder, MD, who enrolled the first European patients in the trial at Ihre Radiologen MVZ in Berlin, Germany, added, “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. The scaffold was easily delivered, and the procedure was aided by visibility of the device under fluoroscopy, which is beneficial to confirm proper placement.”

The company noted that the Motiv scaffold has been available for use in Europe since 2018 when it received CE Mark approval for use below the knee.

Motiv is not available in the United States and other countries that do not accept CE Mark.

Reva Medical stated that the fully bioresorbable Motiv scaffold 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 composed of Reva’s Tyrocore polymer, which provides enhanced scaffold strength in a thin-strut design; improves ease of use, including single-step inflation; and enables visibility of the entire device under fluoroscopy.

In August, Reva Medical 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, advised the company.