R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold.
Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK pivotal trial for the next-generation bioresorbable scaffold.
R3 Vascular makes its novel bioresorbable scaffolds from a unique, ultra-high molecular weight polylactic acid polymer. This, combined with the scaffold design and proprietary processing technology, allow for thinner, stronger, and more flexible sirolimus-coated scaffolds, even at larger diameters and longer lengths, the company said in a news release.
The company specifically engineers its scaffolds to ensure gradual, predictable absorption into the tissue. They leave nothing behind and enable a more naturally functioning vessel.
Dr. Eric A. Secemsky of Beth Israel Deaconess Medical Center in Boston serves as lead investigator for ELITE-BTK. He said the next-generation technology “has the potential to transform the field of peripheral interventions.”
The IDE comes about six months after R3 Vascular closed an $87 million Series B round to support the trial as well.
“[FDA IDE] will enable R3 Vascular to follow-up on our positive first-in-human RESOLV1 study data which demonstrated excellent and promising results with 96% patency by DUS at 6-months,” said Christopher M. Owens, president and CEO of R3 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favorable conclusion will allow the company to complete and pursue a PMA market application for Magnitude with the FDA.”
