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Surmodics Completes Enrollment in TRANSCEND Clinical Trial
Aug. 28, 2019 08:25AM PST
Medical Device InvestingSurmodics (NASDAQ:SRDX) has announced it has finished enrollment of its TRANSCEND clinical trial for its SurVeil drug-coated balloon. As quoted in the press release: “TRANSCEND is a rigorous level one, randomized controlled trial that comes at a very important time for the vascular and interventional community,” said Kenneth Rosenfield, MD, a principal investigator of the …
Surmodics (NASDAQ:SRDX) has announced it has finished enrollment of its TRANSCEND clinical trial for its SurVeil drug-coated balloon.
As quoted in the press release:
“TRANSCEND is a rigorous level one, randomized controlled trial that comes at a very important time for the vascular and interventional community,” said Kenneth Rosenfield, MD, a principal investigator of the TRANSCEND study. “By providing a head-to-head comparison with today’s market leading DCB, this trial will provide data regarding the relative performance of the SurVeil DCB, which represents a new generation of DCB. Beyond the device itself, the new trial design will ultimately provide insight into clinically important questions regarding long-term results. There is great promise that this third-generation DCB will further improve upon current outcomes for this technology and provide additional benefit for clinicians and the patients that they treat.”
The TRANSCEND trial enrolled 446 patients at 65 global sites. The randomized study will evaluate the safety and efficacy of the SurVeil DCB compared with a commercially available DCB in treating peripheral artery disease (PAD) in the upper leg. The results of the trial will also include long-term, patient-level data out to five years.
“I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” said Professor Marianne Brodmann, a TRANSCEND Principal Investigator and the trial’s leading enroller with 44 randomizations. “Our focus now shifts to follow-up and monitoring of these patients and the collection of high-quality data.”
