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Teleflex (TFX) Announces 510(k) Clearance and U.S. Launch of Spectre™ Guidewire

Wednesday, March 15, 2017

Teleflex Incorporated, a leading global provider of medical technologies for critical care and surgery, has announced 510(k) clearance by the Food and Drug Administration and U.S. commercial launch of the Spectre Guidewire.

The Spectre Guidewire is engineered with a smooth stainless steel-to-nitinol dual-core transition that balances strength and agility. It’s a 0.014" guidewire available in 190 cm and 300 cm lengths with a distal hydrophilic coating and a proximal PTFE coating.

Approximately 70% of guidewires used in percutaneous coronary interventions (PCIs) are considered workhorse wires and are used to deliver catheters, balloons, stents, and other diagnostic and therapeutic devices. As a workhorse wire, the Spectre Guidewire was designed to be applicable to the majority of PCIs.

“We are excited to enter the large market for mainstream guidewires with the introduction of Spectre, which offers high-end performance characteristics at competitive prices in response to the demands of our physician customers for more guidewire options,” said Chad Kugler, Vice President of Research & Development of the Vascular Solutions division of Teleflex. “Vascular Solutions designed Spectre with a proximal stainless steel core that combines pushability with support for optimal delivery and a distal nitinol core that is highly flexible and kink-resistant for increased durability. We believe this design offers an excellent combination of trackability and torque control.”

The Spectre Guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.