R3 Vascular, based in Mountain View, California, has received an Investigational Device Exemption (IDE) from the FDA for its Magnitude drug-eluting bioresorbable scaffold. This approval allows the company to initiate the ELITE-BTK pivotal trial, evaluating the device for the treatment of below-the-knee (BTK) peripheral arterial disease (PAD).
Magnitude Scaffold Design and Materials
The Magnitude scaffold is engineered using a unique, ultra-high molecular weight polylactic acid polymer. According to R3 Vascular, this material, combined with the scaffold's design and proprietary processing technology, results in a thinner, stronger, and more flexible sirolimus-coated scaffold. The design facilitates gradual and predictable absorption into the tissue, leaving behind a naturally functioning vessel.
ELITE-BTK Trial Details
The ELITE-BTK trial is scheduled to commence in the first quarter of 2025 and will enroll 264 subjects across up to 60 clinical sites globally. Dr. Eric A. Secemsky of Beth Israel Deaconess Medical Center in Boston will serve as the lead investigator. According to Dr. Secemsky, this next-generation technology has the potential to transform the field of peripheral interventions.
Prior Clinical Data
R3 Vascular's president and CEO, Christopher M. Owens, noted that the IDE will allow the company to build upon positive data from the first-in-human RESOLV1 study. The RESOLV1 study demonstrated excellent results, with a 96% patency rate at 6 months as measured by Duplex Ultrasound (DUS). Favorable outcomes from the ELITE-BTK trial will support a premarket approval (PMA) application to the FDA for the Magnitude scaffold.
Market Context
The IDE approval follows R3 Vascular's $87 million Series B funding round, which was secured to support the ELITE-BTK trial. The successful development and approval of the Magnitude scaffold could address a significant unmet need in the treatment of BTK-PAD, offering a novel bioresorbable option for patients.
