SurModics has received CE Mark approval in Europe for its SurVeil drug-coated balloon (DCB).
The device is designed for the treatment of peripheral artery disease (PAD) with a proprietary drug-excipient formulation for a durable balloon coating.
PAD, which is said to affect 200 million people globally, is a serious and often under-diagnosed circulatory condition caused by a build-up of arterial plaque, typically in the legs. It increases the risk of coronary artery disease, heart attack and stroke and often leads to walking impairment or limb amputation.
Drug-coated balloons are a vital treatment option available for the condition.
Compared to control DCBs, SurVeil shows evenly distributed and durable drug effect and lower incidence of downstream drug particles in the pre-clinical studies.
Surmodics president and CEO Gary Maharaj said: “This CE Mark is a critical milestone and an exciting step forward for Surmodics as we continue to demonstrate industry leadership in the development of pioneering vascular medical devices.
“The design of the SurVeil DCB reflects our dedication to providing innovative solutions that bring real clinical value – benefitting both clinicians and the patients that they treat.”
In 2018, the company offered the exclusive worldwide commercialisation rights for the SurVeil DCB to Abbott .
Following the agreement, Surmodics received a $25m upfront payment and a $10m milestone payment for the completion of patient enrolment in the TRANSCEND clinical trial, which evaluates SurVeil DCB.
Surmodics will now receive an additional $10.8m milestone payment, following the CE Mark approval.
In accordance with its agreement with Abbott, the company will manufacture and supply clinical and commercial quantities of the product.