Teleflex has received US Food and Drug Administration (FDA) clearance for the Wattson temporary pacing guidewire.
The approval expands the company’s structural heart portfolio with the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty (BAV).
The device is being showcased at TVT 2023 (The Structural Heart Summit, 7–10 June, Phoenix , USA) where Teleflex is exhibiting.
In a press release, Teleflex stated that the device features a simple design to create procedural efficiencies, as well as offering dual functionality, by supporting both valve delivery and ventricular bipolar pacing during TAVI or BAV procedures.
“This technology enables us to provide physicians with a new tool specifically engineered to address unmet clinical needs frequently encountered during TAVI or BAV procedures,” said Jake Newman, president of the Americas at Teleflex. “The Wattson temporary pacing guidewire reflects our focus on purposeful innovation and commitment to providing more options to further simplify minimalist TAVI and other structural procedures.”
The device will enter a limited market release phase, with full market release anticipated later this year.