R3 Vascular has announced the treatment of the first patient in its pivotal ELITE-BTK trial, evaluating the next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee peripheral arterial disease (PAD).
Dr. Brian DeRubertis of New York-Presbyterian and Weill Cornell Medicine led the initial procedure. The Magnitude scaffold provides stent-like support while delivering anti-inflammatory and anti-proliferative effects via sirolimus and safely resorbs as the vessel heals.
Constructed from an ultra-high molecular-weight polylactic acid polymer, Magnitude offers enhanced biomechanical strength and ductility, aiming to improve treatment outcomes for patients with chronic limb-threatening ischemia (CLTI).
Christopher M. Owens, R3’s CEO, called this a key milestone and emphasized plans to accelerate trial enrollment to support a future FDA premarket approval (PMA) application.
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