Reva Medical’s MOTIV BTK Trial Meets Primary Efficacy Endpoint

April 29, 2026—Reva Medical, LLC announced primary endpoint results from the pivotal MOTIV BTK randomized clinical trial evaluating the safety and efficacy of the company’s Motiv sirolimus-eluting bioresorbable vascular scaffold in patients with infrapopliteal arterial disease.

The results were presented at the 2026 Charing Cross Symposium in London, United Kingdom by Ehrin Armstrong, MD, Principal Investigator of the MOTIV BTK trial.

According to the company, the prospective multicenter trial met both its primary safety and efficacy endpoints, demonstrating that the Motiv scaffold provides a statistically significant improvement in clinical outcomes compared to balloon angioplasty, the current standard of care.

The trial enrolled a complex population of patients with chronic limb-threatening ischemia, including a high proportion of Rutherford 5 patients and challenging lesion characteristics representative of real-world disease, noted Reva Medical.

As outlined in the company’s press release, the MOTIV BTK clinical trial showed the following:

• Primary efficacy endpoint achieved with 12-month patency outcomes of 70% for the Motiv device vs 48% for balloon angioplasty
• Early clinical benefit was observed at 6 months, with limb salvage and primary patency achieved in 81% of Motiv patients vs 62% for balloon angioplasty
• The primary safety endpoint was met, demonstrating noninferiority to balloon angioplasty

“Patients with chronic limb-threatening ischemia have limited treatment options and face a high risk of limb loss and mortality,” commented Dr. Armstrong in Reva Medical’s press release. “The MOTIV data demonstrate a meaningful and statistically significant improvement over balloon angioplasty, particularly in a complex patient population.”