Surmodics has secured breakthrough device status from the US Food and Drug Administration (FDA) for its Sundance sirolimus-coated balloon (SCB) catheter.

The company has designed Sundance SCB to provide more endovascular revascularisation options for below-the-knee (BTK) arterial lesions in patients suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.

CLI is a debilitating and life-threatening condition that may impact over 3.5 million people by 2020, said the company.

Sundance SCB includes proprietary drug-excipient formulation that uses the active ingredient sirolimus

Sundance SCB features an advanced drug-excipient formulation, which uses the active ingredient sirolimus.

Sirolimus is a potent anti-inflammatory and anti-proliferative compound, which was successfully used in coronary drug-eluting stents.

The delivery of sirolimus to the vessel wall during mechanical dilatation is said to provide an ancillary action of inhibiting the proliferation of cells to reduce restenosis.

Sundance SCB, which is not yet commercialised anywhere in the world, is currently available for investigational use only.

Surmodics president and CEO Gary Maharaj said: “The Sundance SCB is intended to address the unmet clinical need in patients with CLI and infrapopliteal arterial disease by providing a revascularization 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 CLI patients over other available treatment options, and its availability is in the best interest of patients.”

Surmodics provides surface modification technologies for intravascular medical devices, as well as chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays.

In May 2018, Surmodics agreed to acquire thrombectomy technology assets from Embolitech to strengthen peripheral vascular whole-product solutions portfolio.

Embolitech’s technology platform is claimed to have been designed to remove difficult, organized and hard blood clots.