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.
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“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.