R3 Vascular Inc. has secured FDA approval for its Investigational Device Exemption (IDE) application to commence the ELITE-BTK pivotal trial. This trial will evaluate the safety and efficacy of the MAGNITUDE drug-eluting, next-generation bioresorbable scaffold in patients with below-the-knee (BTK) peripheral arterial disease (PAD). The trial's initiation marks a significant step forward in addressing the challenges of treating BTK-PAD, a condition affecting millions worldwide.
The ELITE-BTK trial is a prospective, multi-center study planned to enroll 264 subjects across up to 60 clinical sites globally, with the first patients expected to be enrolled in Q1 2025. The primary endpoint will assess the device's performance in improving blood flow and reducing the need for repeat interventions. Secondary endpoints will include measures of limb salvage, wound healing, and patient-reported outcomes.
MAGNITUDE Scaffold: A Novel Approach to BTK-PAD
The MAGNITUDE scaffold is constructed from an ultra-high molecular weight polylactic acid polymer, coated with sirolimus. This design allows for a thinner, stronger, and more flexible scaffold that gradually resorbs into the tissue, leaving a naturally functioning vessel. The sirolimus coating aims to reduce inflammation and prevent restenosis, a common complication following vascular interventions.
Christopher M. Owens, President and Chief Executive Officer of R3 Vascular, stated, "We are pleased to have FDA approval for our ELITE-BTK pivotal trial, thus allowing enrollment to begin for our next generation MAGNITUDE scaffold. This will enable R3 Vascular to follow-up on our positive first-in-human RESOLV1 study data which demonstrated excellent and promising results with 96% patency by DUS at 6-months."
Addressing a Critical Unmet Need
PAD affects an estimated 8-12 million people in the U.S., with a significant portion suffering from BTK disease. The narrowing of peripheral arteries reduces blood flow to the legs and feet, leading to pain, ulcers, and in severe cases, amputation. Current treatment options, including angioplasty and stenting, have limitations in the BTK region due to the smaller vessel size and increased risk of restenosis.
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, commented, "This is a much-anticipated trial given the advancements and advantages of this next-generation technology which has the potential to transform the field of peripheral interventions. We look forward to evaluating the impact of MAGNITUDE on patient outcomes and its ability to meet this growing clinical need."
Market Opportunity
The global peripheral vascular device market was valued at $12.9 billion in 2023 and is projected to reach $17.4 billion by 2030, with the BTK segment expected to drive significant growth. The ELITE-BTK trial's success could position R3 Vascular as a key player in this expanding market.
