SurVeil drug-coated balloon is designed for the treatment of peripheral artery disease. Credit: Patho / Wiki Commons.

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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

“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.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
HemoSonics has won the 2025 Marketing Award for its impactful promotion of theQuantra Hemostasis System and leadership in blood management education. See how targeted campaigns, thought leadership content, and hands on clinician training are accelerating Quantra’s market traction and shaping the future of hemostasis testing.

Discover the Impact