Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Twin-Pass torque dual access catheter designed for the placement and exchange of guidewires into the coronary or peripheral vasculature.
The Wayne, Penn.-based company said it has launched the Twin-Pass dual access catheter both in the US and internationally.
“The Twin-Pass torque catheter builds on Vascular Solutions’ 12-year legacy with our original Twin-Pass Dual Access catheter, that has been gaining in popularity among interventionalists as the number of complex procedures continues to grow rapidly. This newly-launched version is designed for procedures that call for 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 the physician to achieve precise side-branch access, an important capability in many complex interventions,” vascular solutions division R&D VP Chad Kugler said in a press release.
The Twin-Pass dual access catheter contains both a rapid-exchange lumen and over-the-wire lumen, which can be used for guidewire exchange delivery of a second guidewire into a side branch or fluid injection into a distal vessel segment.
Last month, Teleflex said it won FDA 510(k) clearance for its TrapLine Catheter and saw shares tick up upon the release of 4th quarter and full fiscal year 2016 earnings that beat expectations on The Street.
The TrapLiner is intended for use in conjunction with guide catheters for accessing discrete regions of the coronary or peripheral vasculature to place or exchange interventional devices.