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R3 Vascular announces first patient treated in ELITE-BTK pivotal trial
R3 Vascular recently announced that the first patient in its ELITE-BTK pivotal trial has been treated by Brian DeRubertis, chief of vascular surgery at New York-Presbyterian and Weill Cornell Medicine in New York City. The trial evaluates R3 Vascular’s next-generation…
FDA grants R3 Vascular IDE approval for ELITE-BTK pivotal trial of Magnitude drug-eluting bioresorbable scaffold
R3 Vascular today announced that the Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of the next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee (BTK) peripheral arterial disease (PAD). “We are…
PAD: R3 Vascular reports ‘successful initiation’ of first-in-human study of bioresorbable sirolimus-eluting scaffold
Medical device developer R3 Vascular has reported the “successful initiation” of a first-in-human clinical study evaluating the technical and clinical performance of its Magnitude bioresorbable sirolimus-eluting scaffold (BRS) in patients with critical limb ischemia (CLI) due to occlusive below-the-knee (BTK)…