#USA #San Diego #REVA Medical #MOTIV BTK #Critical Limb Ischemia

REVA Medical Showcases Groundbreaking MOTIV BTK Trial Results

On April 21, 2026, REVA Medical, LLC announced the outcomes of the MOTIV BTK pivotal randomized clinical trial at the prestigious Charing Cross International Symposium in London, UK. The trial focused on the evaluation of the MOTIV® bioresorbable vascular scaffold that releases sirolimus, specifically targeting patients suffering from critical limb-threatening ischemia (CLTI).

The primary efficacy endpoint of the MOTIV BTK trial was successfully met, demonstrating early and sustained clinical benefits in a complex patient population. The results revealed that the MOTIV scaffold achieved a 12-month patency rate of 70%, significantly outperforming the balloon angioplasty, which only reached 48%, representing a remarkable absolute improvement of 22%.

Moreover, at six months post-procedure, the trial showcased an early clinical advantage, with limb salvage and primary patency achieved in 81% of MOTIV patients compared to just 62% for those undergoing balloon angioplasty. In addition, the trial demonstrated non-inferiority concerning safety metrics when compared to the standard balloon angioplasty procedure.

The MOTIV BTK trial involved a diverse group of patients with complex CLTI, a condition recognized as the most severe form of peripheral artery disease, affecting millions worldwide. Patients in this state frequently endure severe pain, chronic non-healing ulcers, and a high risk of amputation and mortality.

Dr. Ehrin Armstrong, the principal investigator from HCA HealthOne Swedish Medical Center in Denver, Colorado, commented on the significance of these findings. He highlighted that patients with CLTI typically have limited treatment options and face elevated risks of limb loss and death. The data from the MOTIV trial indicates a substantial and statistically significant improvement over balloon angioplasty, particularly within this high-risk population.

Balloon angioplasty presently serves as a primary treatment in the United States, yet long-term vessel patency remains a significant challenge. The innovative MOTIV bioresorbable scaffold is designed to open blocked arteries and support the vessel during the healing process before being gradually resorbed, leaving no permanent implant behind.

Furthermore, the MOTIV scaffold incorporates complete radiopacity, thus allowing physicians to visualize it throughout the implantation procedure and optimize placement, particularly within the complex anatomy below the knee.

Jeffrey Anderson, President and CEO of REVA Medical, expressed enthusiasm regarding these trial results. He asserted that the significant benefits observed, alongside the early and durable clinical improvement, affirm the potential of bioresorbable scaffold technology in addressing a critical unmet need for high-risk patient populations.

The MOTIV BTK trial represents a prospective, multicenter, randomized, and controlled study assessing the safety and efficacy of the MOTIV scaffold against balloon angioplasty in patients suffering from infrapopliteal arterial disease.

Disclaimer: This product is in experimental phase and is limited by U.S. federal law to investigational use only.

About REVA Medical

REVA Medical is a medical device company focused on the development and commercialization of bioresorbable polymer technologies for vascular applications. Its proprietary Tyrocore® polymer platform features a combination of strength, radiopacity, and controlled degradation, enabling innovative solutions like the MOTIV® bioresorbable scaffold for peripheral artery ailments.