January 22, 2020
Teleflex Receives FDA Clearance for Wattson Temporary Pacing Guidewire
January 22, 2020—Teleflex announced that it has received 510(k) clearance from the FDA for the company’s Wattson temporary pacing guidewire. The bipolar temporary pacing guidewire is specifically designed for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV).
Teleflex plans to commence a limited market release of the device in the United States during the first quarter of 2020.
According to the company, the Wattson device provides guidewire support with bipolar pacing capabilities, all in one device; a multiple electrode configuration and bipolar design, engineered for optimal capture during rapid pacing; and a procedural alternative that is designed to help avoid a range of complications associated with traditional right ventricular rapid pacing.
Teleflex stated that the device features a 0.035-inch pigtail guidewire that supports valve delivery and allows simultaneous intraventricular bipolar pacing during TAVR or BAV procedures. It is designed to simplify and shorten TAVR procedures by eliminating the need for routine use of central venous access and transvenous temporary pacing catheters.