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FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of Its Magnitude Drug-Eluting Next-Generation Bioresorbable Scaffold for BTK PAD
R3 Vascular Inc. News
MOUNTAIN VIEW, Calif. – R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.
“We are pleased to have FDA approval for our ELITE-BTK pivotal trial, thus allowing enrollment to begin for our next generation MAGNITUDE scaffold. This 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 Chief Executive Officer 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.”
MAGNITUDE is a next generation bioresorbable scaffold with the potential to address one of the greatest needs for patients suffering from Chronic Limb-Threatening Ischemia 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 the sirolimus coated scaffolds to be thinner, stronger, and more flexible even at larger diameters and longer lengths. R3 Vascular scaffolds are specifically engineered to ensure that they gradually and predictably absorb into the tissue, leaving nothing behind and enabling a more naturally functioning vessel.
Eric A. Secemsky, MD, MSc, Director of Vascular Intervention at Beth Israel Deaconess Medical Center in Boston, Massachusetts and lead investigator for the ELITE-BTK pivotal trial said, “This is a much-anticipated trial given the advancements and advantages of this next-generation technology which has the potential to transform the field of peripheral interventions. We look forward to evaluating the impact of MAGNITUDE on patient outcomes and its ability to meet this growing clinical need.”
In May of 2024 the company announced the closing of its $87 million Series B financing round to support the ELITE-BTK IDE pivotal trial as well as additional research and development, global regulatory submissions, scale up of manufacturing processes, and initial commercialization.
About R3 Vascular Inc.
R3 Vascular is a privately-held medical device company that develops a novel technology platform for the next generation of fully bioresorbable drug eluting sirolimus coated vascular scaffolds. These are designed to deliver the ‘stent-like’ support of a scaffold along with the anti-inflammatory and anti-proliferative result of sirolimus, but ‘disappearing’ over time as the vessel heals. R3 Vascular is headquartered in Mountain View, California. More information can be found at www.r3vascular.com.
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