Teleflex's Twin-Pass Torque Dual-Access Catheter Cleared by FDA
March 15, 2017—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.
According to Teleflex, the 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.
The company's 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, stated Teleflex.