#USA #San Diego #Clinical Trial #REVA Medical #MOTIV BTK

Positive Results from the MOTIV BTK Clinical Trial

REVA Medical, LLC has recently announced impressive outcomes from its pivotal randomized clinical trial known as MOTIV BTK. This trial assessed the effectiveness of the MOTIV® bioresorbable vascular scaffold, which releases sirolimus, in treating patients suffering from critical limb ischemia (CLI). The results, which were unveiled during the Charing Cross International Symposium in London, indicate a significant leap forward in treatment options for a complex patient population that traditionally faces limited choices.

The MOTIV BTK trial met its primary efficacy endpoint, showing a statistically significant improvement in clinical outcomes when compared to the current standard treatment—balloon angioplasty. Specifically, the 12-month primary patency rate was 70% with the MOTIV scaffold compared to just 48% for balloon angioplasty, an absolute improvement of 22%. Additionally, at the six-month mark, there was an early clinical benefit, with primary patency rates of 81% in patients treated with MOTIV versus 62% for those undergoing angioplasty.

The cohort in the MOTIV BTK study included a diverse set of patients with complex chronic lower limb ischemia (CLTI), featuring a high proportion of Rutherford stage 5 patients, which reflects real-world clinical practices and challenges.

Dr. Ehrin Armstrong, a leading interventional cardiologist at HCA HealthOne Swedish Medical Center in Denver, Colorado, remarked on the study's findings, stating, "Patients with critical limb ischemia face a daunting array of treatment limitations, marked by a high risk of both amputation and mortality. The MOTIV study data demonstrates a statistically significant upgrade compared to balloon angioplasty, especially in this complex patient population."

Chronic lower limb ischemia (CLTI) represents the most severe form of peripheral artery disease, affecting millions worldwide. It's associated with severe pain, non-healing wounds, and a significant risk of amputations. While balloon angioplasty remains a core treatment method in the U.S., long-term vascular patency continues to pose challenges for healthcare providers. The MOTIV scaffold aims to address these issues by temporarily opening obstructed arteries and supporting them during the healing process before being gradually absorbed by the body, eliminating permanent implants.

Significantly, the MOTIV scaffold is designed for complete radiopacity, allowing physicians to directly visualize the scaffold during deployment, which helps optimize placement in challenging below-the-knee anatomies.

Jeffrey Anderson, CEO of REVA Medical, expressed optimism regarding the evolution represented by the MOTIV trial results. He stated, "These findings signify a major advancement for patients with below-the-knee pathology. The degree of benefit observed, combined with the early and sustained clinical improvements, reinforces the potential of bioresorbable scaffold technology to meet an unmet critical need in this high-risk patient group."

The MOTIV BTK trial is a prospective, multicenter, randomized controlled study evaluating the safety and efficacy of the MOTIV stent against balloon angioplasty in patients with infrapopliteal artery disease. It is critical to note that this device is still under investigation and is permitted for research use only as per federal law in the United States.

About REVA Medical

REVA Medical is a medical device firm dedicated to developing and commercializing bioresorbable polymer technologies for vascular applications. Their proprietary Tyrocore® polymer platform integrates strength, radiopacity, and controlled degradation, paving the way for innovative solutions like the MOTIV® bioresorbable scaffold for peripheral arterial disease.