Teleflex's Spectre Guidewire Cleared by FDA

 

March 15, 2017—Teleflex Incorporated announced US Food and Drug Administration 510(k) clearance and the United States commercial launch of the Spectre guidewire. 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.

According to Teleflex, the 0.014-inch Spectre guidewire is available in 190- and 300-cm lengths. The device has a distal hydrophilic coating and a proximal polytetrafluoroethylene coating. The guidewire's smooth stainless steel–to-nitinol dual-core transition balances strength and agility. The Spectre was designed to be a workhorse guidewire, applicable to the majority of percutaneous coronary interventions.

The device's proximal stainless steel core combines pushability with support for optimal delivery. Additionally, the distal nitinol core is flexible and kink resistant for increased durability. The combination provides trackability and torque control, stated the company.

 

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