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.