Live case showcases successful below-the-knee revascularization with two MOTIV® scaffolds; late-breaking analysis shows higher efficacy endpoint rates with MOTIV versus balloon angioplasty in both Rutherford 4 and Rutherford 5 CLTI populations

SAN DIEGO, Oct. 6, 2026 /PRNewswire/ — REVA Medical, LLC today announced the successful completion of a live case demonstration featuring the MOTIV® sirolimus-eluting bioresorbable vascular scaffold and the presentation of late-breaking clinical results from the MOTIV BTK pivotal trial at the Vascular InterVentional Advances (VIVA) 2026 conference in Las Vegas, Nevada.

Live Case Demonstration

Professor Andrej Schmidt, MD, of University Hospital Leipzig, performed a live, below-the-knee revascularization procedure transmitted to attendees at VIVA26 in Las Vegas. The patient, a 72-year-old woman with peripheral vascular chronic limb-threatening ischemia (CLTI), was classified as Rutherford Category 5 and presented with a nonhealing ulcer.

Prof. Schmidt successfully treated the patient using two MOTIV sirolimus-eluting bioresorbable scaffolds: a 4.0 mm × 48 mm MOTIV scaffold and a 3.5 mm × 24 mm MOTIV scaffold. The procedure achieved successful revascularization of the below-the-knee peripheral artery with an excellent angiographic result.

Late-Breaking Clinical Trial Presentation

Ehrin Armstrong, MD, of HCA HealthOne Swedish Medical Center in Denver, Colorado, presented a subgroup analysis from the MOTIV pivotal trial during VIVA26’s Late-Breaking Clinical Trials session. The presentation, titled “Clinical Outcomes of the MOTIV Sirolimus-Eluting Resorbable Scaffold in Rutherford Category 4 Versus Rutherford Category 5 Chronic Limb-Threatening Ischemia: Subgroup Analysis From the MOTIV Pivotal Trial,” evaluated outcomes in patients with two severities of CLTI.

The prospective, multicenter, single-blind randomized controlled trial enrolled 292 patients with Rutherford Category 4 or 5 CLTI and compared the MOTIV scaffold with standard balloon angioplasty (PTA). The study population was highly complex: 69% of enrolled patients were Rutherford 5.

In the subgroup analysis, the composite endpoint of limb salvage and primary patency favored MOTIV over PTA at both 6 and 12 months in each Rutherford category:

• At 6 months, the endpoint was achieved in 87.2% of Rutherford 4 patients treated with MOTIV, compared with 76.3% with PTA, and in 77.0% of Rutherford 5 patients treated with MOTIV, compared with 55.8% with PTA.
• At 12 months, the endpoint was achieved in 76.7% of Rutherford 4 patients treated with MOTIV, compared with 54.5% with PTA, and in 65.7% of Rutherford 5 patients treated with MOTIV, compared with 46.2% with PTA.
• MOTIV 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 5 cohort.

“Today’s live case demonstration and the late-breaking MOTIV results brought the potential of our bioresorbable scaffold technology into sharp focus at VIVA26,” said Jeffrey Anderson, President and Chief Executive Officer of REVA Medical. “The successful procedure and the consistent clinical outcomes observed across both Rutherford 4 and Rutherford 5 patient populations reinforce our commitment to addressing the needs of patients with complex below-the-knee disease.”

CLTI is the most severe form of peripheral artery disease and may lead to severe pain, non-healing wounds, and amputation. The MOTIV bioresorbable scaffold is designed to open blocked arteries, support the vessel during healing, and then gradually be reabsorbed by the body without leaving a permanent implant.

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. Visit us on social media: LinkedIn

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SOURCE REVA Medical, LLC