R3 Vascular’s ELITE-BTK Pivotal Trial of Magnitude Scaffold Commences

April 22, 2025—R3 Vascular Inc. announced that the first patient was enrolled in the company’s ELITE-BTK pivotal trial evaluating its Magnitude next-generation drug-eluting bioresorbable scaffold for below-the-knee (BTK) peripheral artery disease (PAD).

The patient was treated by Brian DeRubertis, MD, Chief of the Division of Vascular & Endovascular Surgery at New York-Presbyterian and Weill Cornell Medicine in New York, New York.

“I am honored to have enrolled the first two patients in R3 Vascular’s ELITE-BTK pivotal trial, primarily because this type of technology has been needed by our patients for years,” commented Dr. DeRubertis in the company’s press release. “I have spent much of my career researching novel devices for vascular disease, including bioresorbable scaffolds, and while there have been some recent successes in the BTK PAD trial landscape, there remain significant unmet needs in this area. We expect the results of this important trial will reveal Magnitude’s unique potential to further advance treatment and improve patient outcomes for patients with vascular disease.”

In November 2024, R3 Vascular announced that the FDA granted investigational device exemption approval to initiate the ELITE-BTK pivotal trial. In January 2025, the company announced that it received WCG institutional review board approval for the ELITE-BTK pivotal trial.