GlobeNewswire01.22.20
Teleflex Incorporated global provider of medical technologies for critical care and surgery, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the Wattson Temporary Pacing Guidewire—the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV).
This innovative device offers clinicians a 0.035” pigtailed guidewire that supports valve delivery and allows simultaneous intraventricular bipolar pacing during TAVR or BAV procedures. Wattson Temporary Pacing Guidewire is designed to simplify and shorten TAVR procedures by eliminating the need for routine use of central venous access and transvenous temporary pacing catheters.
The Wattson Temporary Pacing Guidewire offers:
“FDA 510(k) clearance is another important milestone for the Wattson Temporary Pacing Guidewire and for our Interventional business,” said Matt Anderson, President and General Manager of the Interventional business unit of Teleflex. “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.”
Teleflex currently plans to commence a limited market release of the device in the U.S. during the first quarter of 2020.
This innovative device offers clinicians a 0.035” pigtailed guidewire that supports valve delivery and allows simultaneous intraventricular bipolar pacing during TAVR or BAV procedures. Wattson Temporary Pacing Guidewire is designed to simplify and shorten TAVR procedures by eliminating the need for routine use of central venous access and transvenous temporary pacing catheters.
The Wattson Temporary Pacing Guidewire 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
“FDA 510(k) clearance is another important milestone for the Wattson Temporary Pacing Guidewire and for our Interventional business,” said Matt Anderson, President and General Manager of the Interventional business unit of Teleflex. “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.”
Teleflex currently plans to commence a limited market release of the device in the U.S. during the first quarter of 2020.