Surmodics has announced the company has now resumed patient enrolment into its TRANSCEND clinical trial, and is nearly 75% of the way to its goal of 446 randomised patients.
Patient enrolment in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB), was temporarily paused following the March 15 publication of a US Food and Drug Administration (FDA) 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,” says Gary Maharaj, Surmodics president and CEO. “Following multiple conversations, we have 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 randomising patients.”
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The TRANSCEND randomised trial will evaluate the SurVeil DCB for treatment of peripheral arterial disease (PAD) in the upper leg compared to a commercially available DCB treatment. The results of the trial will also include long-term, patient-level data out to five years. The company continues to assess the impact of the March 15 FDA communication on its expectations regarding the timing of completion of patient enrolment in the TRANSCEND clinical trial and related regulatory approvals for the SurVeil DCB.
“Patient safety is the top priority in every study, so pausing trial enrolment while implementing the recommendations from the FDA was in the best interest of both our patients and this trial,” said William Gray, the national co-principal investigator of the TRANSCEND study. “We are pleased to see many sites enthusiastically resuming enrolments. 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.”
