Subgroup Analysis Presented From Reva’s MOTIV BTK Pivotal Trial

October 8, 2026—Reva Medical, LLC announced the presentation of results from a subgroup analysis of the MOTIV BTK pivotal trial for the company’s investigational Motiv sirolimus-eluting bioresorbable vascular scaffold in the treatment of below-the-knee (BTK) peripheral artery disease.

Ehrin Armstrong, MD, presented the data during a late-breaking clinical trial session at VIVA 2026, the Vascular Interventional Advances conference.

According to the company, the subgroup analysis evaluated outcomes in patients with two severities of chronic limb-threatening ischemia (CLTI). The prospective, multicenter, single-blind randomized controlled trial enrolled 292 patients with Rutherford class 4 or CLTI; 69% of patients were Rutherford class 5.

The investigators compared the Motiv scaffold with standard balloon angioplasty (PTA).

As summarized in Reva Medical’s press release, the subgroup analysis showed that the composite endpoint of limb salvage and primary patency at both 6 and 12 months in each Rutherford category favored Motiv versus PTA as follows:

• At 6 months in Rutherford class 4 patients, 87.2% versus 76.3%
• At 6 months in Rutherford class 5 patients, 77.0% versus 55.8%
• At 12 months in Rutherford class 4 patients, 76.7% versus 54.5%
• At 12 months in Rutherford class 5 patients, 65.7% versus 46.2%

The Motiv device also demonstrated higher acute technical and procedural success rates than PTA in both groups, with the relative advantage most pronounced in the more complex Rutherford class 5 cohort, stated the company.

Also at VIVA 2026, the company stated that a live case demonstration featured the Motiv scaffold. The procedure was conducted by Professor Andrej Schmidt, MD, of University Hospital Leipzig in Leipzig, Germany, and transmitted to attendees at the conference in Las Vegas, Nevada.

The patient was a 72-year-old woman who had peripheral vascular CLTI classified as Rutherford class 5 and presented with a nonhealing ulcer. Prof. Schmidt performed a BTK revascularization procedure using two Motiv sirolimus-eluting bioresorbable scaffolds: a 4.0- X 48-mm Motiv scaffold and a 3.5- X 24-mm Motiv scaffold. The procedure achieved successful revascularization of the BTK peripheral artery with an excellent angiographic result, stated Reva Medical.

In April 2026, Reva Medical announced that the primary endpoint results from the pivotal MOTIV BTK randomized clinical trial were presented at the 2026 Charing Cross Symposium by Principal Investigator Ehrin Armstrong, MD. The trial met its primary safety and efficacy endpoints in the treatment of complex infrapopliteal arterial disease.