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.

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“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.