R3 Vascular recently announced that the first patient in its ELITE-BTK pivotal trial has been treated by Brian DeRubertis (New York-Presbyterian and Weill Cornell Medicine, New York, USA). The trial evaluates R3 Vascular’s next-generation drug-eluting bioresorbable scaffold, Magnitude, for below-the-knee (BTK) peripheral arterial disease (PAD).
“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 chief executive officer of R3 Vascular. “Moving forward we look to accelerate enrolment, paving the way for a PMA [premarket approval] market application with the FDA [US Food and Drug Administration].”
DeRubertis commented on the importance of the ELITE-BTK pivotal trial, saying: “I am honoured 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. 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.”
“The start of this trial marks the continuation of our journey in providing a groundbreaking technology for patients who have suffered from this debilitating disease for many years without effective therapeutic options,” said Kamal Ramzipoor, founder and chief technology officer of R3 Vascular. “Magnitude is a next-generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from chronic limb-threatening ischaemia due to below-the-knee PAD. R3 Vascular’s novel bioresorbable scaffolds are made from a unique, ultra-high molecular weight polylactic acid polymer. This polymer, combined with the company’s scaffold design and proprietary processing technology allow for superior biomechanical properties with strength and ductility. We believe these properties will drive extremely positive outcomes, especially long-term for real-world patients. We look forward to advancing our product through its clinical development with the ultimate goal of having a market-leading position.”
