Surmodics Sundance has launched a new catheter device, Sundance Sirolimus-Coated Balloon (SCB) under the Agency's Breakthrough Devices Program.
The device has been designed to improve the 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 occlusive cardiovascular disease that can result in amputation and even death.
The Sundance SCB includes a proprietary drug-excipient formulation of sirolimus - potent anti-inflammatory and anti-proliferative compound and is designed to reduce restenosis or recurrent narrowing of the arteries.
The catheter device has the potential for improved outcomes in CLI patients over other available treatment options.
