Teleflex has received 510(k) clearance from the FDA for its Wattson temporary pacing guidewire. A press release reports that this is the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty. It adds that this “innovative device” offers clinicians a 0.035” pigtailed guidewire that supports valve delivery and allows simultaneous intraventricular bipolar pacing during TAVI or valvuloplasty procedures.
The guidewire is designed to simplify and shorten TAVI procedures by eliminating the need for routine use of central venous access and transvenous temporary pacing catheters. According to the press release, it offers:
- Guidewire support with bipolar pacing capabilities all in one device
- A multiple electrode configuration and bipolar design, engineered to inspire confidence in capture during rapid pacing
- A procedural alternative designed to help avoid a range of complications associated with traditional right ventricular rapid pacing.
Matt Anderson, president and general manager of the Interventional business unit of Teleflex, says: “FDA 510(k) clearance is another important milestone for the Wattson temporary pacing guidewire and for our Interventional business. 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 TAVI and valvuloplasty procedures.”
Teleflex currently plans to commence a limited market release of the device in the USA during the first quarter of this year.