Teleflex secures 510(k) clearance for Spectre guidewire and Torque dual access catheter

14 March 2017 (Last Updated March 14th, 2017 18:30)

Medical technologies provider Teleflex has secured 510(k) clearance from the Food and Drug Administration (FDA) for its Spectre guidewire and Torque dual access catheter.

Medical technologies provider Teleflex has secured 510(k) clearance from the Food and Drug Administration (FDA) for its Spectre guidewire and Torque dual access catheter.

Available in 190cm and 300cm lengths, the Spectre is a 0.014" guidewire with a distal hydrophilic coating and a proximal PTFE coating.

The guidewire is designed as a workhorse wire to enable application in majority of percutaneous coronary interventions (PCIs).

"The catheter is designed to access discrete regions of the coronary and / or peripheral vasculature, enable placement and exchange of guidewires and subselectively infuse / deliver diagnostic and therapeutic agents."

It can be used in percutaneous procedures to position interventional devices such as catheters within the coronary and / or peripheral vasculature.

Teleflex Vascular Solutions division Research & Development vice-president Chad Kugler said: “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 Torque is a twin-pass dual access catheter with rapid-exchange (RX) lumen and an over-the-wire (OTW) lumen.

The OTW lumen allows guidewire exchange, subsequent delivery of a second guidewire into a side branch, or fluid injection to a desired distal vessel segment, along side a 0.014" guidewire introduced into the main branch through the RX lumen.

The catheter is designed to access discrete regions of the coronary and / or peripheral vasculature, enable placement and exchange of guidewires and subselectively infuse / deliver diagnostic and therapeutic agents.

While the firm is planning to commercially launch the guidewire in the US, the catether is set for the US, as well as international launch.