Teleflex's Bipolar Temporary Pacing Guidewire Gets FDA Nod
Zacks Investment Research | Jan 27, 2020 11:18PM ET
Teleflex Incorporated (NYSE:TFX) received the FDA’s 510(k) clearance for its bipolar temporary pacing guidewire — Wattson Temporary Pacing Guidewire. Per Teleflex, the device will be the first commercially available bipolar temporary pacing guidewire, specially designed for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV).
Notably, the company is planning a limited market release of the device in the United States during the first quarter of 2020.
With the latest regulatory approval, Teleflex aims to strengthen foothold in the interventional cardiology and peripheral vascular devices market globally. Notably, the interventional cardiology and peripheral vascular business is a component of the company’s Americas segment.
Significance of the Approval
The temporary pacing guidewire is a significant procedural improvement over the traditional right ventricular rapid pacing. The device also supports valve delivery and allows simultaneous intraventricular bipolar pacing during TAVR or BAV procedures. It, thus, simplifies the TAVR procedure and reduces the procedural time.
Per the company, the device, with its cutting-edge technology, will significantly help surgeons to improve patient outcomes by addressing clinical needs, which were previously not met during TAVR and BAV surgeries.
Industry Prospects
Per a report published on Zacks Investment Research
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