R3 Vascular Wins FDA IDE Approval to Begin Bioresorbable Scaffold Trial

The U.S. Food and Drug Administration (FDA) has granted investigational device exemption approval to R3 Vascular Inc. to begin studying its next-generation drug-eluting bioresorbable scaffold for below-the-knee peripheral artery disease (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,” R3 Vascular President/CEO Christopher M. Owens said. “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 (BTK) PAD. R3 Vascular’s bioresorbable scaffolds are made from an ultra-high molecular weight polylactic acid polymer. Combined with the company’s scaffold design and proprietary processing technology, the polymer 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 they gradually and predictably absorb into the tissue, leaving nothing behind and enabling a more naturally functioning vessel, according to the company.

“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,” stated Eric A. Secemsky, M.D., director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, and ELITE-BTK trial lead investigator. “We look forward to evaluating the impact of MAGNITUDE on patient outcomes and its ability to meet this growing clinical need.”

In May this year, R3 Vascular closed $87 million in Series B financing to support the ELITE-BTK IDE trial as well as additional research and development, global regulatory submissions, manufacturing scale-up, and initial commercialization.

PAD is a narrowing of the peripheral arteries that carry blood away from the heart to other parts of the body, according to the American Heart Association. 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 million to 12 million U.S. residents and one in 20 Americans older than 50. The global peripheral vascular device market was valued at $12.9 billion last year and is expected to reach $17.4 billion by 2030, with significant growth emanating from the BTK segment.

Mountain View, Calif.-based R3 Vascular is a privately-held medical device firm developing technology that is incorporated into next-generation fully bioresorbable drug-eluting sirolimus coated vascular scaffolds. The structures are designed to deliver a scaffold’s “stent-like” support along with the anti-inflammatory and anti-proliferative result of sirolimus, but “disappearing” over time as the vessel heals.