Teleflex Incorporated (TFX - Free Report) 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.
Per a report published on Data Bridge Market Research, the global interventional cardiology and peripheral vascular devices market is expected to witness a CAGR of 8.08% between 2019 and 2026. Factors like increasing elderly population and rising incidence of chronic illnesses are expected to drive the market.
Given the market potential, the approval is well-timed.
Of late, Teleflex has witnessed a slew of developments in its product portfolios, including regulatory clearance.
The company received the FDA’s clearance for an expanded indication for the use of the UroLift System to treat enlarged prostates (between 80cc and 100cc) in January 2020.
Teleflex announced plans of showcasing the Interventional product portfolio, including the MANTA Vascular Closure Device and Langston Dual Lumen Catheters, at the PCR London Valves in London, U.K., in November 2019.
Shares of Teleflex have gained 41.3% in the past year compared with the industry’s 14.4% rally.
Zacks Rank & Key Picks
Currently, Teleflex carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Perrigo Company plc (PRGO - Free Report) , Hill-Rom Holdings, Inc. (HRC - Free Report) and Myomo, Inc. (MYO - Free Report) .
Perrigo Company, currently carrying a Zacks Rank #2 (Buy), has a projected long-term earnings growth rate of 2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Hill-Rom’s long-term earnings growth rate is estimated at 11.7%. The company currently carries a Zacks Rank #2.
Myomo’s long-term earnings growth rate is estimated at 25%. It currently carries a Zacks Rank #2.
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