MOTIV BTK randomized trial met primary efficacy endpoint, with early and sustained clinical benefit in a complex patient population
SAN DIEGO, April 21, 2026 /PRNewswire/ -- REVA Medical, LLC today announced primary endpoint results from the MOTIV BTK randomized pivotal clinical trial evaluating the MOTIV sirolimus-eluting bioresorbable vascular scaffold in patients with critical limb-threatening ischemia (CLTI). The results were presented today at the Charing Cross International Symposium in London, UK.
The MOTIV BTK trial met both its primary safety and efficacy endpoints, demonstrating that the MOTIV scaffold provides a statistically significant improvement in clinical outcomes compared to the current standard of care, balloon angioplasty.
Results of the one-year MOTIV BTK clinical trial showed:
- Primary efficacy endpoint achieved, with 12 month patency outcomes of 70% for MOTIV vs. 48% for balloon angioplasty, representing a 22% absolute improvement
- Early clinical benefit observed at 6 months, with limb salvage and primary patency achieved in 81% of MOTIV patients vs. 62% for balloon angioplasty
- Primary safety endpoint met, demonstrating non-inferiority to balloon angioplasty
The trial enrolled a complex CLTI population, including a high proportion of Rutherford 5 patients and challenging lesion characteristics representative of real-world disease.
"Patients with critical limb-threatening ischemia have limited treatment options and face a high risk of limb loss and mortality," said Ehrin Armstrong, MD, MSc, Interventional Cardiology and Vascular Intervention HCA HealthOne Swedish Medical Center, Denver, Colorado and Principal Investigator of the MOTIV BTK trial. "The MOTIV data demonstrate a meaningful and statistically significant improvement over balloon angioplasty, particularly in a complex patient population."
CLTI is the most severe form of peripheral artery disease, affecting millions of patients worldwide and often leading to severe pain, non-healing wounds, and amputation. Balloon angioplasty remains a primary treatment option in the U.S., but long-term vessel patency remains a significant challenge. The MOTIV bioresorbable scaffold is designed to open blocked arteries, support the vessel during healing, and then gradually be reabsorbed by the body, restoring the vessel without leaving a permanent implant.
In addition, the MOTIV scaffold is designed with full radiopacity, enabling physicians to directly visualize the scaffold during implantation and optimize placement in complex below-the-knee anatomy.
"The MOTIV trial results represent a significant advancement for patients in the treatment of below-the-knee disease," said Jeffrey Anderson, President and Chief Executive Officer of REVA Medical. "The magnitude of benefit observed, along with early and sustained clinical improvement, reinforces the potential of bioresorbable scaffold technology to address a critical unmet need in this high-risk patient population."
The MOTIV BTK trial is a prospective, multicenter, randomized controlled study evaluating the safety and efficacy of the MOTIV scaffold compared to balloon angioplasty in patients with infrapopliteal arterial disease.
CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only.
About REVA Medical
REVA Medical is a medical device company focused on developing and commercializing bioresorbable polymer technologies for vascular applications. The company's proprietary Tyrocore polymer platform combines strength, radiopacity, and controlled degradation, enabling innovative solutions such as the MOTIV bioresorbable scaffold for peripheral artery disease.
Douglas Henson
REVA Medical, LLC
+1 858-966-3024
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