FDA Approves R3 Vascular's Novel MAGNITUDE® Bioresorbable Scaffold for Below-the-Knee PAD

R3 Vascular has received approval from the U.S. Food and Drug Administration to start its ELITE-BTK pivotal trial. This trial will test the next generation of the company’s drug-eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.

The approval allows R3 Vascular to proceed with the trial, building on positive results from its earlier RESOLV1 study. This study showed promising outcomes with 96% patency by Doppler Ultrasound at six months.

The ELITE-BTK trial will involve 264 patients across up to 60 clinical sites globally and is expected to begin in the first quarter of 2025. If successful, the trial will support the company’s application for premarket approval (PMA) of MAGNITUDE by the FDA.

MAGNITUDE is designed to address a critical need in the treatment of Chronic Limb-Threatening Ischemia caused by below-the-knee PAD.

The scaffold is made from a unique, ultra-high molecular weight polylactic acid polymer, combined with R3 Vascular’s advanced scaffold design and proprietary technology.

This makes the scaffolds thinner, stronger, and more flexible, even at larger diameters and longer lengths. As the scaffold gradually absorbs into the tissue, it leaves nothing behind, promoting natural vessel function.

Source: https://www.globenewswire.com/fr/news-release/2024/11/04/2973818/0/en/FDA-Grants-R3-Vascular-IDE-Approval-for-ELITE-BTK-Pivotal-Trial-of-its-MAGNITUDE-Drug-Eluting-Next-Generation-Bioresorbable-Scaffold-for-Below-the-Knee-Peripheral-Arterial-Disease.html