R3 Vascular Inc. has received FDA approval for an Investigational Device Exemption (IDE) to commence its ELITE-BTK pivotal trial, evaluating the MAGNITUDE drug-eluting bioresorbable scaffold for treating below-the-knee (BTK) peripheral arterial disease (PAD). The trial is set to begin in Q1 2025.
The ELITE-BTK trial is a prospective, multi-center study that will enroll 264 subjects across up to 60 global clinical sites. The study aims to evaluate the safety and efficacy of the MAGNITUDE scaffold in patients with Chronic Limb-Threatening Ischemia (CLTI) due to BTK-PAD. Successful completion of the trial will support a pre-market approval (PMA) application to the FDA for MAGNITUDE.
MAGNITUDE Scaffold: A Novel Approach to BTK-PAD
MAGNITUDE is a next-generation bioresorbable scaffold designed to address the critical needs of patients suffering from CLTI due to BTK-PAD. Constructed from an ultra-high molecular weight polylactic acid polymer, the sirolimus-coated scaffold is engineered to be thinner, stronger, and more flexible, even at larger diameters and longer lengths. The unique design ensures gradual and predictable absorption into the tissue, leaving behind a naturally functioning vessel.
Clinical Perspective and Trial Design
According to Eric A. Secemsky, M.D., MSc, Director of Vascular Intervention at Beth Israel Deaconess Medical Center and lead investigator for the ELITE-BTK pivotal trial, this trial is highly anticipated due to the advancements and advantages of this next-generation technology, which has the potential to transform the field of peripheral interventions. He looks forward to evaluating the impact of MAGNITUDE on patient outcomes and its ability to meet this growing clinical need.
Addressing a Significant Unmet Need
PAD affects an estimated 8-12 million people in the U.S., with lower-extremity PAD being the most common form. The global peripheral vascular device market was valued at $12.9 billion in 2023 and is projected to reach $17.4 billion by 2030, driven by significant growth in the BTK segment. R3 Vascular's MAGNITUDE scaffold represents a potential advancement in addressing this growing clinical need.
R3 Vascular's Strategy
R3 Vascular closed an $87 million Series B financing round in May 2024 to support the ELITE-BTK IDE pivotal trial, further research and development, global regulatory submissions, manufacturing scale-up, and initial commercialization efforts.
