Surmodics has announced the receipt of US Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).
A company press release notes that the SurVeil DCB may now be marketed and sold in the USA to physicians for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (≤180mm in length) in femoral and popliteal arteries having reference vessel diameters of 4mm to 7mm. The SurVeil DCB received CE mark Certification in the European Union in June 2020.
“Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” said Gary Maharaj, president and CEO of Surmodics. “It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral arterial disease and the physicians that treat them. I would like to thank our internal SurVeil DCB team and our external advisors, investigators and partners for their multi-year efforts to make this achievement possible.”
Abbott has exclusive worldwide commercialisation rights for the SurVeil DCB. Surmodics will manufacture and supply the product and realise revenue from product sales to Abbott and a share of profits from Abbott’s third-party sales. Surmodics will also receive a US$27 million milestone payment from Abbott. The company expects to recognise approximately US$24 to US$24.5 million of revenue related to the milestone payment in the third quarter of its fiscal year 2023.
Maharaj continued: “Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialisation rights for the SurVeil DCB. We will discuss details on the developments and update our fiscal year 2023 financial guidance during our third quarter earnings call.”
“I am excited that the Surveil DCB will be available to treat patients in the USA,” said Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), co-principal investigator of the TRANSCEND clinical trial. “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.”