Teleflex (NYSE:TFX) announced today that it won FDA 510(k) clearance for its Wattson temporary pacing guidewire for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV).
The Wattson guidewire is designed to simplify and shorten procedures by eliminating the need for the routine use of central venous access and transvenous temporary pacing catheters. Wayne, Pa.-based Teleflex touts the system as the first commercially available bipolar temporary pacing guidewire specifically for use in TAVR and BAV.
Teleflex’s product is designed to maintain bipolar pacing capabilities and includes a multiple-electrode configuration while functioning as a procedural alternative, helping to avoid the complications associated with traditional right ventricular rapid pacing, according to a news release.
The company said it plans to initiate a limited market release in the U.S. during the first quarter of fiscal 2020 before making it fully commercially available in the country.
“FDA 510(k) clearance is another important milestone for the Wattson temporary pacing guidewire and for our interventional business,” Teleflex interventional business unit president & GM Matt Anderson said in the news release. “This innovative device allows us to provide a cutting-edge tool designed to help clinicians improve patient outcomes by addressing a previously unmet clinical need during TAVR and BAV procedures.”