R3 Vascular Initiates First-In-Human Study of Magnitude Bioresorbable Sirolimus-Eluting Scaffold

September 2, 2021—R3 Vascular Inc. announced the initiation of its first-in-human clinical study evaluating the technical and clinical performance of the company’s Magnitude bioresorbable sirolimus-eluting scaffold (BRS) to treat patients with critical limb ischemia caused by occlusive below the knee (BTK) peripheral artery disease.

R3 Vascular is a privately held, early-stage medical device company headquartered in Mountain View, California, with additional operations in Munich, Germany.

According to the company, the R3 Vascular platform’s scaffold design and bioresorbable polymer technology provide biomechanical performance comparable to metallic stents. The Magnitude BRS is designed to balance mechanical strength and flexibility. The device’s bioresorbable polymer provides the structural support needed in this complex vascular territory. The Magnitude BRS has 98-µm strut thickness across all its usable range of diameters.

“In this early clinical experience, we successfully tested the deliverability and mechanical performance of the Magnitude BRS,” commented Marianne Brodmann, MD, in the company’s press release. Dr. Brodmann, who is Professor and Head, Clinical Division of Medical University of Graz in Graz, Austria, continued, “Postprocedural angiographic and duplex ultrasound data confirm the mechanical properties and ‘stent-like’ results of the Magnitude BRS device in presence of a high-disease burden. We are looking forward to expanding the patient population cohort and following the clinical results over time.”

Juan F. Granada, MD, who is a strategic advisor to R3 Vascular, added, “In BTK intervention, the prevention of vessel recoil following balloon dilatation is key to prevent negative remodeling and maintain vessel patency over time. BRS offer the best of both worlds by providing vessel support while it is needed and allowing the opportunity for future reinterventions, which is important in this type of patients. The successful validation of this technology may finally offer an effective and durable way to treat patients with this complex medical condition.”