Surmodics, Inc. Announces 12-Month Data from its TRANSCEND Clinical Trial Has Been Presented at the Leipzig Interventional Course 2021 Virtual Event
January 25, 2021 at 06:55 pm IST
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Surmodics, Inc. announced that 12-month data from its TRANSCEND clinical trial has been presented at the Leipzig Interventional Course (LINC) 2021 virtual event. The TRANSCEND Trial is a global, multi-center, randomized, controlled clinical trial (RCT) with 1:1 randomization to the SurVeil™ DCB (Surmodics, Inc.) or IN.PACT® Admiral® DCB (Medtronic), in patients with symptomatic femoropopliteal artery disease. The primary efficacy endpoint was primary patency at 12 months, defined as a composite of freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis. The primary safety endpoint was a composite of freedom from device or procedure related death through 30 days and freedom from above-ankle amputation and clinically driven target vessel revascularization (CD-TVR) within 12 months. Primary results, presented by TRANSCEND co-principal investigator Dr. Kenneth Rosenfield, M.D., demonstrate that the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB with regards to both safety and efficacy, while delivering a substantially lower drug dose.
Surmodics, Inc. is a provider of performance coating technologies for intravascular medical devices and chemical and biological components for in vitro diagnostic (IVD) immunoassay tests and microarrays. The Company's segments include Medical Device and IVD. The Medical Device segment manufactures and licenses performance coatings, including surface modification coating technologies to improve access, deliverability and predictable deployment of medical devices and drug-delivery coating technologies to provide site-specific drug-delivery from the surface of a medical device, with end markets that include neurovascular, peripheral, coronary and structural heart. It manufactures vascular intervention medical devices, including drug-coated balloons, and radial access balloon catheters and guide sheaths. The IVD segment manufactures chemical and biological components used in in vitro diagnostic immunoassay and molecular tests within the diagnostic and biomedical research markets.