EDEN PRAIRIE, Minn.– Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that Professor Ramon Varcoe will present 6-month data from the SWING Trial, a first-in-human study of the safety and performance of the Sundance™ Sirolimus Drug-Coated Balloon. The session will be held on Tuesday, October 11, at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
Professor Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi), co-lead investigator of the SWING Trial, is a vascular surgeon at Sydney’s Prince of Wales and Prince of Wales Hospital where he is Director of Operating Theatres, and Director of Surgery and Anesthetics for the South East Sydney Health District. He will review safety and efficacy data collected through 6-months of follow-up for 35 patients with occlusive disease of the infra-popliteal arteries who were treated at study sites in Australia, New Zealand, or locations in Europe. Study subjects will be followed for 36 months after the index procedure. Professor Andrew Holden, MBChB, FRANZCR, EBIR, ONZM, Director of Northern Region Interventional Radiology Service at Auckland City Hospital in Auckland, New Zealand, is also a co-lead investigator for the SWING Trial.
The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, enhancing sirolimus delivery and sustaining therapeutic levels in the artery. Sirolimus, a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. The delivery of sirolimus to the vessel wall during mechanical dilatation provides an ancillary action of inhibiting the proliferation of cells, with the intended purpose of reducing restenosis. The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.
“The Sundance Sirolimus Drug-Coated Balloon represents a significant advancement in the treatment of patients with Critical lower limb ischemia and infrapopliteal arterial disease, providing a revascularization option that may lead to an improved quality of life, the reduced need for major bypass surgical intervention, and a decrease in the risk of amputation,” said Varcoe. “I am excited to present the 6-month SWING data to an audience of my peers at AMP Europe.”
