Surmodics has announced the receipt of 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 U.S. 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.
“I am excited that the Surveil DCB will be available to treat patients in the USA,” said Kenneth Rosenfield, MD, an interventional cardiologist at Massachusetts General Hospital in Boston, 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.”