Sam Brusco, Associate Editor06.20.23
Surmodics has received U.S. Food and Drug Administration (FDA) approval for its SurVeil drug-coated balloon (DCB).
SurVeil DCB is used for percutaneous transluminal angioplasty (after proper vessel preparation) of de novo or restenotic lesions (≤180 mm in length)in femoral or popliteal arteries with reference diameters if 4-7 mm. SurVeil DCB earned CE mark certification in June 2020.
“Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” Gary Maharaj, president and CEO of Surmodics told the press. “It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery 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 Labs has global commercialization rights for the SurVeil DCB—Surmodics will manufacture and supply the product, realize revenue from sales to Abbott, and a share of profits from Abbott’s third-party sales. Surmodics will also earn a $27 million milestone pyment from Abbott.
Maharaj continued, “Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB. We’ll 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 US,” said Kenneth Rosenfield, M.D., co-principal investigator of the TRANSCEND clinical trial for SurVeil DCB. “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 vs 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.”
SurVeil DCB is used for percutaneous transluminal angioplasty (after proper vessel preparation) of de novo or restenotic lesions (≤180 mm in length)in femoral or popliteal arteries with reference diameters if 4-7 mm. SurVeil DCB earned CE mark certification in June 2020.
“Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history,” Gary Maharaj, president and CEO of Surmodics told the press. “It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery 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 Labs has global commercialization rights for the SurVeil DCB—Surmodics will manufacture and supply the product, realize revenue from sales to Abbott, and a share of profits from Abbott’s third-party sales. Surmodics will also earn a $27 million milestone pyment from Abbott.
Maharaj continued, “Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB. We’ll 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 US,” said Kenneth Rosenfield, M.D., co-principal investigator of the TRANSCEND clinical trial for SurVeil DCB. “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 vs 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.”