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

Significant Breakthrough in Critical Limb Ischemia Treatment

REVA Medical, LLC has released positive findings from the primary endpoints of the randomized clinical MOTIV BTK Trial, which focused on the effectiveness of the MOTIV scaffold, a bioresorbable device coated with sirolimus for patients suffering from critical limb ischemia (CLI). These findings were shared during the Charing Cross International Symposium in London on April 21, 2026.

The MOTIV BTK study successfully met both primary safety and efficacy endpoints, demonstrating that the MOTIV scaffold significantly improves clinical outcomes when compared to current standard treatments, such as balloon angioplasty. Key findings from the one-year clinical study revealed:

• - A primary efficacy endpoint was achieved with 12-month patency outcomes showing 70% for MOTIV compared to 48% for balloon angioplasty, resulting in a 22% absolute improvement.
• - Early clinical benefits were evident at six months, with limb preservation and primary patency rates of 81% in the MOTIV cohort versus 62% in the balloon angioplasty group.
• - The primary safety endpoint was met, confirming non-inferiority to balloon angioplasty.

This study included a complex population of CLI patients, reflecting a high proportion of Rutherford 5 patients and challenging lesion characteristics, making it highly representative of real-world conditions. Dr. Ehrin Armstrong, a key investigator of the MOTIV BTK study at HCA HealthOne Swedish Medical Center in Denver, Colorado, highlighted the challenges faced by CLI patients who have limited treatment options and are at a high risk for limb loss and mortality. He stated, "The MOTIV data indicate a significant and statistically important improvement over balloon angioplasty, particularly in a complex patient population."

CLI is the most severe form of peripheral artery disease and affects millions of patients worldwide, often leading to severe pain, non-healing wounds, and amputations. While balloon angioplasty remains the primary treatment option in the U.S., the long-term vessel patency poses a significant challenge for healthcare providers. The bioresorbable MOTIV scaffold is designed to reopen blocked arteries, support the vessel during healing, and gradually dissolve, restoring the vessel without leaving a permanent implant in place.

Moreover, the MOTIV scaffold features full X-ray visibility, enabling physicians to visualize the scaffold during implantation, thus optimizing placement in complex below-the-knee anatomies.

Jeffrey Anderson, President and CEO of REVA Medical, emphasized the significance of the MOTIV study results, noting, "This is a major advancement for patients dealing with below-the-knee diseases. The observed benefit levels and the early, persistent clinical improvements underscore the potential of bioresorbable scaffold technology to address a critical unmet medical need in this high-risk patient group."

The MOTIV BTK study is a prospective, multicenter, randomized controlled trial assessing the safety and efficacy of the MOTIV scaffold compared to balloon angioplasty in patients with infrapopliteal artery disease. It is noteworthy that this investigational device is restricted by federal law (USA) for research purposes only.

About REVA Medical

REVA Medical is a prominent medical device company dedicated to developing and marketing bioresorbable polymer technologies tailored for vascular applications. The company's proprietary Tyrocore® polymer platform combines strength, X-ray visibility, and controlled degradation, enabling innovative solutions like the MOTIV® scaffold for peripheral artery disease applications.