Medical device and in vitro diagnostic technologies provider Surmodics has secured CE mark approval for its SurVeil drug-coated balloon (DCB) to market in the European Union region.

The SurVeil DCB is a next-generation device, which applies advanced technology for the treatment of peripheral artery disease (PAD)

SurVeil DCB features a drug-excipient formulation for a durable balloon coating

The device is comprised of a drug-excipient formulation for a durable balloon coating. It is produced using an advanced process to enhance coating uniformity.

In February 2018, Surmodics signed an agreement with Abbott, which offered Abbott with exclusive worldwide commercialisation rights for the SurVeil DCB.

As per terms of the deal, Surmodics secured a $25m upfront payment and $10m milestone payment for the completion of patient recruitment in the TRANSCEND clinical trial.

Surmodics will secure an additional $10.8m milestone payment, as a result of CE mark attainment.

The company will admit around $6.5m as revenue in its fiscal third quarter and may earn up to an additional $45m for future product development milestones.

As part of the agreement, Surmodics will take responsibility for the manufacturing and supplying of clinical and commercial quantities of the product. The company will realise revenue based on initial product sales to Abbott, in addition to sharing profits resulting from third-party sales.

According to the company, the SurVeil DCB is not yet commercially available in the US and is for investigational use only in the country.

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. Congratulations go out to the entire Surmodics team on this well-deserved achievement.”

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