Surmodics’ Sundance SCB Catheter Earns FDA Breakthrough Device Designation


October 29, 2019—Surmodics, Inc. announced that the company’s Sundance sirolimus-coated balloon (SCB) catheter has been granted Breakthrough Device designation from the FDA.

According to the company, the Sundance SCB has been designed to enhance the endovascular revascularization options for below-the-knee arterial lesions in patients with critical limb ischemia and infrapopliteal arterial disease. The device includes Surmodics’ drug-excipient formulation that uses the active ingredient sirolimus and its potent anti-inflammatory and antiproliferative characteristics.

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 SCB is not available for sale anywhere in the world and currently is for investigational use only, advised the company.

The FDA’s Breakthrough Device program was launched in December 2018 to streamline the market clearance/approval process for products that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA has indicated that the goal of the program is to help patients and health care providers have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization.


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