Sundance sirolimus-coated balloon catheter granted FDA breakthrough device designation


Surmodics has announced that the US Food and Drug Administration (FDA) has designated its Sundance sirolimus-coated balloon catheter as a breakthrough device under the agency’s breakthrough devices programme.

The programme, launched in December 2018, is designed 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.

According to a press release, the Sundance sirolimus-coated balloon has been designed to enhance the endovascular revascularisation options for below-the-knee (BTK) arterial lesions in patients suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.

The Sundance balloon includes a proprietary drug-excipient formulation that utilises the active ingredient sirolimus, a potent anti-inflammatory and anti-proliferative compound which 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 balloon is not available for sale anywhere in the world, and currently is for investigational use only.

No compelling therapeutic options exist for patients suffering from infrapopliteal disease. Interventions for patients with CLI are especially challenging due to the advanced stage of their disease. For the patient, an improvement in treatment outcomes may lead to improved quality of life, faster wound healing, reduced need for major bypass surgical intervention, and a decreased risk of amputation.

“The Sundance sirolimus-coated balloon is intended to address the unmet clinical need in patients with CLI 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,” said Gary Maharaj, Surmodics president and chief executive officer. “The Sundance [balloon] has the potential for improved outcomes in CLI patients over other available treatment options, and its availability is in the best interest of patients.”


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