Teleflex Announces 510(k) Clearance Of Twin-Pass Torque Dual Access Catheter

(RTTNews) - Teleflex Inc. (TFX), a provider of medical technologies for critical care and surgery, announced 510(k) clearance by the Food and Drug Administration and both U.S. and international commercial launch of the Twin-Pass Torque Dual Access Catheter.

Twin-Pass Dual Access Catheters contain both a rapid-exchange (RX) lumen and an over-the-wire or OTW lumen. With a 0.014" guidewire deployed through the RX lumen into the main branch, the OTW lumen can be used for guidewire exchange, subsequent delivery of a second guidewire into a side branch, or fluid injection to a desired distal vessel segment.

The Twin-Pass Torque Catheter is intended to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement and exchange of guidewires, and to subselectively infuse/deliver diagnostic and therapeutic agents.

Separately, Teleflex 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.