R3 Vascular Receives IDE Approval for ELITE-BTK Pivotal Trial of Magnitude Scaffold

November 13, 2024—R3 Vascular Inc. recently announced that the FDA granted investigational device exemption (IDE) approval to initiate the company’s ELITE-BTK pivotal trial of Magnitude, its next-generation drug-eluting bioresorbable scaffold for treating below-the-knee (BTK) peripheral arterial disease (PAD) with the potential of addressing chronic limb-threatening ischemia.

Eric A. Secemsky, MD, who is Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts, serves as lead investigator for the ELITE-BTK pivotal trial.

“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,” commented Dr. Secemsky in R3 Vascular’s press release. “We look forward to evaluating the impact of Magnitude on patient outcomes and its ability to meet this growing clinical need.”

The company stated that its bioresorbable scaffolds are made from an ultra-high molecular weight polylactic acid polymer. The polymer combined with the company’s scaffold design and processing technology allow the sirolimus-coated scaffolds to be thin, strong, and flexible even at larger diameters and longer lengths.

In October 2023, results from RESOLV I study, the first-in-human evaluation of the Magnitude device, were presented by Marianne Brodmann, MD, at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation in Las Vegas, Nevada.

In May 2024, the company announced it closed a $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. The same press release announced that Christopher M. Owens was named President and Chief Executive Officer of R3 Vascular.

“We are pleased to have FDA approval for our ELITE-BTK pivotal trial, thus allowing enrollment to begin for our next-generation Magnitude scaffold,” commented Owens in the current press release. “This will enable R3 Vascular to follow-up on our positive first-in-human RESOLV I study data, which demonstrated excellent and promising results with 96% patency by duplex ultrasound at 6-months. 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 premarket approval market application for Magnitude with the FDA.”