Surmodics has announced that the FDA has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the agency’s Breakthrough Devices programme. The FDA has already designed the sirolimus devices MagicTouch (Concept Medical), Virtue sirolimus-eluting balloon (Orchestra BioMed), and Selution sustained limus release (MedAlliance) as Breakthrough Devices.
The Sundance SCB has been designed to enhance the endovascular revascularisation options for below-the-knee arterial lesions in patients with critical limb ischaemia and infrapopliteal arterial disease. A press release reports that Sundance balloon includes a proprietary drug-excipient formulation that uses the active ingredient sirolimus.
Gary Maharaj, Surmodics president and CEO, comments: “The Sundance SCB is intended to address the unmet clinical need in patients with critical limb ischaemia and infrapopliteal arterial disease by providing a revascularisation option with a proprietary sirolimus coating. This second platform adds to our stable of drug-coated balloon devices and furthers our effort to provide treatment solutions for the entire peripheral anatomy. The Sundance SCB has the potential for improved outcomes in critical limb ischaemia patients over other available treatment options, and its availability is in the best interest of patients.”