Surmodics SurVeil DCB’s PMA Application Requires Additional Information for FDA Review

January 19, 2023—Surmodics, Inc. announced it has received a letter from the FDA related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB), which is a next-generation device for the treatment of peripheral artery disease (PAD). The device includes the company’s drug-excipient formulation using an innovative process to improve coating uniformity.

According to the company, the FDA letter indicated the application is not currently approvable, while it provided specific guidance for a path forward.

The FDA stated that certain information within two general categories—biocompatibility and labeling—must be added by an amendment to the company’s PMA application to place it in approvable form. The additional information would require further testing and analysis. The FDA letter did not question the human clinical data submitted nor request any further human clinical data, noted the company.

Gary Maharaj, Chief Executive Officer of Surmodics, commented in the company’s press release, “We are disappointed by the FDA’s response to our PMA application and continue to have confidence in our SurVeil DCB including its compelling performance in the TRANSCEND clinical study. We are evaluating the issues raised in the FDA’s letter and plan to meet with agency representatives regarding its contents.

“Based on our discussion with the agency, our team and external advisors will determine the appropriate path forward. Concurrently, we will be evaluating options to reduce our use of cash given this development. We expect to address these topics further in connection with our upcoming first quarter fiscal 2023 earnings call.”

The TRANSCEND study is a global, multicenter, pivotal investigational device exemption clinical trial that enrolled 446 patients with femoropopliteal disease and Rutherford class 2 to 4. Investigators randomized the patients to either the low-dose (2.0 µg/mm²) paclitaxel SurVeil DCB (n = 222) or the high-dose (3.5 µg/mm²) paclitaxel In.Pact Admiral (Medtronic; n = 224).

Intermediate-term (24-month) follow-up results from the TRANSCEND study were presented by Kenneth Rosenfield, MD, at the VIVA Foundation’s VIVA22 conference held October 31 to November 3 in Las Vegas, Nevada.

Dr. Rosenfield reported that the data continue to demonstrate similar outcomes for the SurVeil DCB compared with the high-dose DCB for the treatment of patients with symptomatic PAD caused by stenosis of the femoral and/or popliteal arteries. The data also demonstrated noninferiority of the SurVeil DCB compared to the In.Pact Admiral DCB. Dr. Rosenfield’s presentation is available on the company’s website.

In the United States, the SurVeil DCB is an investigational device that is limited by Federal law to investigational use, advised the company.

Surmodics announced European CE Mark approval for the device in June 2020.