FDA clears new guidewire used for valve delivery and ventricular pacing during TAVR, BAV procedures

The Wattson temporary pacing guidewire from Teleflex

The Wattson temporary pacing guidewire. A) SAPIEN 3 deployment in the aortic position with the Wattson wire. B) Tricuspid valve-in-valve with SAPIEN 3 with the Wattson wire. C) Pigtail with exposed electrodes (arrows). D) Pacing set-up with adaptor connected to external pacing device. Images courtesy of Hensey et al. and EuroIntervention.

The device, now on display at TVT 2023 in Phoenix, is scheduled to begin hitting the market in the months ahead. 

FDA warning letter: iRhythm committed multiple violations, failed to report patient deaths in time

Zio AT mobile cardiac telemetry device

“It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA,” according to the warning letter. These issues, the agency added, “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.”