R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.
“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,” said Christopher M. Owens, President and Chief Executive Officer of R3 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favorable conclusion will allow the company to complete and pursue a PMA market application for MAGNITUDE with the FDA.”
MAGNITUDE is a next-generation bioresorbable scaffold with the potential to address one of the greatest needs of patients suffering from Chronic Limb-Threatening Ischemia due to below-the-knee PAD. R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allows the sirolimus-coated scaffolds to be thinner, stronger, and more flexible even at larger diameters and longer lengths. R3 Vascular scaffolds are specifically engineered to ensure that they gradually and predictably absorb into the tissue, leaving nothing behind and enabling a more naturally functioning vessel.
Eric A. Secemsky, M.D., MSc, Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and lead investigator for the ELITE-BTK pivotal trial said, “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.”
In May of 2024, the company announced the closing of its $87 million Series B financing round to support the ELITE-BTK IDE pivotal trial as well as additional research and development, global regulatory submissions, scale-up of manufacturing processes, and initial commercialization.
According to the American Heart Association PAD is a narrowing of the peripheral arteries that carry blood away from the heart to other parts of the body. The most common type is lower-extremity PAD, where blood flow is reduced to the legs and feet. The National Institutes of Health estimates PAD affects 8-12 million people in the U.S. and one in 20 Americans over the age of 50. The global peripheral vascular device market was valued at $12.9 billion in 2023 and is expected to reach $17.4 billion by 2030 with significant growth coming from the below-the-knee segment.
