Last month, the Eden Prairie, Minn.-based company paused enrollment 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.
“Immediately following publication of the March 15 FDA communication, we reached out to the agency seeking guidance on the recommendations and the impact on TRANSCEND. Following multiple conversations, we’ve taken several actions in response to the agency’s recommendations, including updates to investigator communications, patient Informed Consent Forms (ICF), and data safety review and patient follow-up procedures. A number of our trial sites have already secured IRB or Ethics Committee approval of the updated ICF and are actively enrolling and randomizing patients,” prez & CEO Gary Maharaj said in a press release.
Surmodics said that the trial is nearly 75% of the way to completion, with a goal of enrolling 446 subjects. The company said that it is working with the FDA and following its recommendations, including updated ICFs, the inclusion of an ongoing clinical events committee and a data safety monitoring board and an aggressive patient follow-up program for both new patients an those already treated.
The company’s TRANSCEND trial aims to evaluate the SurVeil DCB for treating patients with peripheral artery disease in the upper leg, comparing it to treatment with a commercially available DCB treatment. The trial is slated to extend out to five years.
“Patient safety is the top priority in every study, so pausing trial enrollment while implementing the recommendations from the FDA was in the best interest of both our patients and this trialWe’re pleased to see many sites enthusiastically resuming enrollments. The TRANSCEND trial comes at a critical time in the endovascular field and will provide important safety and efficacy data for the next generation SurVeil DCB as it compares to the Medtronic IN.Pact DCB and will ultimately be useful for physicians and the patients that they treat,” national co-principal investigator Dr. William Gray said in a prepared statement.
Shares in Surmodics have risen approximately 0.8% so far today, at $41.09 as of 3:08 p.m. EDT.