Daily Newsletter

21 June 2023

Daily Newsletter

21 June 2023

FDA approves Surmodics’ SurVeil drug-coated balloon

Abbott holds exclusive commercialisation rights globally for the device.

RanjithKumar Dharma June 21 2023

The US Food and Drug Administration (FDA) has granted approval for SurModics’ SurVeil drug-coated balloon (DCB).

Designed for the treatment of peripheral artery disease, the device features a drug-excipient formulation for a durable balloon coating.

The device is intended for use by physicians in percutaneous transluminal angioplasty procedures after appropriate vessel preparation.

It is suitable for treating de novo or restenotic lesions up to 180mm in length in femoral and popliteal arteries, which have reference vessel diameters ranging from 4mm to 7mm.

According to the company, the 24-month data from the TRANSCEND study showed the sustained durability of the device’s efficacy and safety outcomes.

TRANSCEND clinical trial co-principal investigator Kenneth Rosenfield said: “The Surveil DCB is the next-generation DCB as established by results from the TRANSCEND trial, which is the only head-to-head pivotal study that has been conducted versus the market-leading DCB.

“The Surveil DCB successfully demonstrated non-inferior safety and effectiveness at two years post-treatment with a substantially lower drug dose.”

In June 2020, the company also secured CE Mark certification for the device in the European Union.

Abbott holds exclusive global commercialisation rights for the SurVeil DCB.

Surmodics will be responsible for the manufacturing and supply of the product. It will realise revenue through sales to Abbott, as well as receive a portion of the profits from third-party sales of Abbott.

Furthermore, Abbott will make a milestone payment of $27m to Surmodics.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors


Sign up to the newsletter: In Brief

Your corporate email address *
First name *
Last name *
Company name *
Job title *
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.