R3 Vascular’s Magnitude Bioresorbable Scaffold Evaluated in RESOLV FIH Study

October 31, 2023—The RESOLV study is a first-in-human evaluation of the Magnitude thin-strut 98-μm drug-eluting bioresorbable scaffold (R3 Vascular) for its potential to provide high vessel patency in the treatment of below-the-knee arteries.

Patients included in RESOLV, who were stratified by Rutherford class (RC), presented with lesions up to 12 cm in the tibioperoneal trunk, posterior tibial artery, anterior tibial artery, and peroneal artery. Angiography and intravascular ultrasound (IVUS) were used to identify vessel characteristics and morphology.

The 6-month results for 30 treated patients in the ongoing study—as stratified by baseline RC of 3, 4, and 5—were presented by Marianne Brodmann, MD, during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

As summarized in the press release from the VIVA symposium, the RC 3 cohort (5/30, 17%) included a total of five lesions treated. The mean age of patients in this cohort was 76.8± 6.0 years, and the mean body mass index (BMI) was 23.9±3.5 kg/m². The mean proximal vessel diameter by IVUS was 4.1 mm.

In the RC 3 cohort, the mean in-segment diameter stenosis was 80.1% before treatment, which decreased to 16.6% after scaffold implantation and increased to 23.0% at 6 months.

There were three lesions treated in the RC 4 cohort (3/30, 10%). At baseline, mean age of patients was 74.3±6.3 years and mean BMI was 32.7±3.7 kg/m². The mean proximal vessel diameter by IVUS was 4.1 mm.

In the RC 4 cohort, the mean in-segment diameter stenosis was 77.7% before treatment, which decreased to 7.9% after scaffold implantation and increased to 25.4% at 6 months.

There were 23 lesions treated in the RC 5 cohort (22/30, 73%). At baseline, mean age of patients was 74.5±5.8 years and mean BMI was 28.2±5.8 kg/m². The mean proximal vessel diameter by IVUS was 4.3 mm.

In the RC 5 cohort, the mean in-segment diameter stenosis was 78.4% before treatment, which decreased to 14.8% after scaffold implantation and increased to 28.8% at 6 months.

Overall, across the severity of peripheral artery disease by Rutherford class, the investigators observed significant improvement after placement of the Magnitude bioresorbable scaffold, with sustained patency by angiography at 6 months, reported Dr. Brodmann in the VIVA press release.

In September 2021, R3 Vascular announced the initiation of the FIH trial of the Magnitude bioresorbable scaffold gin the treatment of BTK artery disease.