Surmodics says patient enrollment resumed into TRANSCEND clinical trial
Surmodics announced that it has resumed patient enrollment into its TRANSCEND clinical trial and is nearly 75% of the way to its goal of 446 randomized patients. Patient enrollment in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon, was temporarily paused following the March 15 publication of a Food & Drug Administration letter to physicians. The letter included an update on the Agency's preliminary analysis of a potentially concerning signal of increased long-term mortality with paclitaxel-coated devices and recommended that physicians consider alternative treatment methods until additional analysis has been performed. "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, 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," said Gary Maharaj, Surmodics President and CEO.