April 16, 2019
Enrollment Resumes in the TRANSCEND Trial of Surmodics' SurVeil Paclitaxel-Coated Balloon
April 17, 2019—Surmodics, Inc. announced that it has resumed patient enrollment for the TRANSCEND clinical trial and has completed approximately 75% of its goal of enrolling 446 randomized patients. TRANSCEND is the pivotal clinical trial for the company's SurVeil drug-coated balloon (DCB).
According to the company, enrollment in the TRANSCEND trial was temporarily paused after the publication of the FDA letter to physicians on March 15 that 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.
The TRANSCEND randomized trial will evaluate the SurVeil DCB for treatment of peripheral artery 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 5 years.
In response to that letter, Surmodics advised it has taken several actions to adhere to FDA's recommendations, including updates to investigator communications, patient Informed Consent Forms (ICFs), data safety review procedures, and patient follow-up procedures. A number of TRANSCEND trial sites have already secured institutional review board or ethics committee approval of the updated patient ICFs and are actively enrolling and randomizing patients, noted the company.
Surmodics outlined the FDA recommendations and the company's corresponding action as follows:
- FDA: Follow device recommendations from March 15 letter. Surmodics: Communicated these recommendations to trial investigators.
- FDA: Update patient ICFs. Surmodics: Initiated process to update ICFs at sites worldwide.
- FDA: Include ongoing independent data safety monitoring board (DSMB) review. Surmodics: Ongoing clinical events committee and DSMB reviews were initiated at trial onset.
- FDA: Take measures to increase follow-up with patients. Surmodics: Establishing an aggressive patient follow-up program for both new patient randomizations and those already treated.
William Gray, MD, is the National Coprincipal Investigator of the TRANSCEND study. In the company's announcement, Dr. Gray commented, “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 trial. We’re pleased to see many sites enthusiastically resuming enrollments."
Dr. Gray continued, "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.”
According to Surmodics, the company continues to assess the impact of the March 15 FDA communication on its expectations regarding the timing of completion of patient enrollment in the TRANSCEND clinical trial and related regulatory approvals for the SurVeil DCB.
For all news related to the ongoing controversy regarding paclitaxel use in PAD, please visit Endovascular Today's comprehensive continuing coverage page.