Surmodics (NSDQ:SRDX) shares fell last week after the FDA wrote a letter to doctors detailing a trend of heightened mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices.
In an SEC filing, the company said that it’s working with the FDA to clarify how the company should proceed with an ongoing clinical trial of its paclitaxel-coated SurVeil balloon.
Surmodics’ Transcend clinical trial is slated to enroll up to 446 people with symptomatic PAD.
“The company is currently assessing the impact of the FDA communication on the Transcend clinical trial, its expectations regarding the timing of completion of patient enrollment in the Transcend clinical trial and related regulatory approvals for the SurVeil DCB, and any corresponding effect on its fiscal 2019 financial guidance,” Surmodics wrote.
In its letter to healthcare providers, the FDA reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.
The agency said that doctors should seek alternative treatment options for patients while the agency assesses the long-term mortality signal linked to paclitaxel devices.
SRDX shares were trading at $45.65 apiece in mid-morning activity today, down -4%.