US-based medical and diagnostic technologies provider Surmodics has received the US Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).
The SurVeil DCB is a next-generation device that deploys advanced technology to treat peripheral artery disease (PAD).
It uses a unique drug-excipient formulation for a durable balloon coating and is manufactured using a novel process to improve the uniformity of its coating.
With the FDA approval, the SurVeil DCB is allowed to be marketed and sold in the US, for percutaneous transluminal angioplasty, following proper vessel preparation.
It can be used for angioplasty of de-novo or restenotic lesions, measuring 180mm, in femoral and popliteal arteries with reference vessel diameters of 4mm to 7mm, said the company.
Surmodics president and CEO Gary Maharaj said: “Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history.
“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.”
“Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialisation rights for the SurVeil DCB.”
Abbott holds 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.
Also, the company is eligible to receive a $27m milestone payment from Abbott.
Results from the 24-month TRANSCEND clinical trial showed the safety and efficacy outcomes of SurVeil DCB, with sustained durability.
In the study, SurVeil DCB was non-inferior to IN.PACT Admiral DCB, at a lower drug dose.
Furthermore, SurVeil DCB is designed to enable more uniform drug distribution, effective drug transfer, and reduce downstream particulates and downstream emboli, said the medical device company.
