R3 Vascular announced today that a doctor treated the first patient in the ELITE-BTK pivotal trial of its drug-eluting bioresorbable scaffold.
Dr. Brian DeRubertis of New York-Presbyterian and Weill Cornell Medicine treated the first patient. The trial evaluates the company’s next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee peripheral arterial disease (PAD).
Mountain View, California-based R3 designed Magnitude to deliver the “stent-like” support of a scaffold. However, they also deliver anti-inflammatory and anti-proliferative results of sirolimus while disappearing over time as the vessel heals.
Made from a unique, ultra-high molecular-weight polylactic acid polymer, Magnitude could address chronic limb-threatening ischemia (CLTI). Combined with the scaffold design and proprietary processing technology, it allows for superior biomechanical properties with strength and ductility.
DeRubertis said the results of ELITE-BTK should demonstrate Magnitude’s “unique potential” to advance patient outcomes.
“The treatment of the first patient in our ELITE-BTK pivotal trial by distinguished vascular surgeon and researcher Dr. Brian DeRubertis is a significant milestone as we commence our effort to fully demonstrate the efficacy and safety of our next generation Magnitude scaffold,” said Christopher M. Owens, president and CEO of R3 Vascular. “Moving forward we look to accelerate enrollment, paving the way for a PMA market application with the FDA.”
