FDA Grants Approval to Surmodics for SurVeil™ Drug-Coated Balloon
Tuesday, June 20, 2023
Surmodics, a leading provider of medical device and in vitro diagnostic technologies, has announced that it has received FDA approval for its SurVeil™ drug-coated balloon (DCB). The SurVeil DCB is now authorized for sale and use in the United States for percutaneous transluminal angioplasty of de novo or restenotic lesions in femoral and popliteal arteries with reference vessel diameters of 4 mm to 7 mm and lengths of up to 180 mm. This approval follows the SurVeil DCB's CE Mark Certification in the European Union in June 2020.
Gary Maharaj, the President and CEO of Surmodics, expressed that obtaining FDA approval for the SurVeil DCB is a significant milestone for the company. He acknowledged the efforts of the SurVeil DCB team, as well as external advisors, investigators, and partners, in making this achievement possible. Maharaj emphasized that the approval represents a crucial step in their mission to develop next-generation products that benefit millions of individuals affected by peripheral artery disease, along with the physicians treating them.
Under an agreement, Abbott holds exclusive worldwide commercialization rights for the SurVeil DCB, while Surmodics will be responsible for manufacturing and supplying the product. Surmodics will earn revenue from product sales to Abbott, as well as a share of profits from Abbott's third-party sales. Additionally, Surmodics will receive a $27 million milestone payment from Abbott. The company expects to recognize approximately $24.0 to $24.5 million of revenue related to this payment in the third quarter of its fiscal year 2023.
The SurVeil DCB is considered a next-generation device in the treatment of peripheral artery disease (PAD). It incorporates a proprietary drug-excipient formulation for a durable balloon coating and utilizes an innovative manufacturing process to improve coating uniformity. The SurVeil DCB's superiority has been demonstrated in the TRANSCEND trial, where it showed non-inferior safety and effectiveness compared to the market-leading DCB, despite utilizing a significantly lower drug dose.