Teleflex’s Twin-Pass Torque Dual-Access Catheter Cleared by FDA
Teleflex Incorporated announced that its Twin-Pass Torque dual-access catheter has received 510(k) clearance by the US Food and Drug Administration. The company also initiated the United States and international commercial launch of the device.
Twin-Pass Torque catheter is intended to access discrete regions of the coronary and/or peripheral vasculature, facilitate placement and exchange of guidewires, and subselectively infuse/deliver diagnostic and therapeutic agents.
Twin-Pass dual-access catheters contain a rapid-exchange (RX) lumen and an over-the-wire (OTW) lumen. With a 0.014-inch 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 designed for procedures that require the delivery of two interventional guidewires from a single catheter in clinical situations where catheter delivery and torsional control are paramount. The new version of the Twin-Pass will allow physicians to achieve precise side branch access.