Cerebral Embolic Protection For TAVR: Start-Ups Compete
This article was originally published in Start Up
With minimally invasive left-heart procedures like transcatheter aortic valve replacement becoming increasingly safe and commonplace, attention has turned to procedure-associated brain injury from showers of emboli. Several medtech start-ups are developing devices that could protect patients’ brains during not only TAVR, but also surgical aortic valve replacement, atrial fibrillation ablation and other left-heart procedures.
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Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. Over the last month, 31 new trials started, 25 trial were completed, one trial was "reinitiated," and six trials were terminated or suspended, according to meddevicetracker.
Results of the SENTINEL trial, announced at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium conference, show that the Sentinel transcatheter embolic protection device is safe and captures embolic debris in 99% of transcatheter aortic valve replacement patients. Sentinel may also lower the 30-day stroke rate and new brain-lesion volume compared to unprotected TAVR, but the reduction failed to be statistically significant in the trial.
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.