Ev3 Announces SpideRX Enrollment in Second Phase of Trial
Ev3, a privately held endovascular medical device company, has received approval to include the SpideRX Embolic Protection Device in the second arm of the company's carotid clinical trial.
Ev3 has completed enrollment in the first phase of this trial using the SPIDER Embolic Device and the Protege GPS Self-Expanding Stent. The second phase of the trial will evaluate the SpideRX Device when used with the approved and commercially available Guidant Rx Acculink Carotid Stent System. The trial is called CREATE (carotid revascularization with ev3 arterial technology evolution).
The SpideRX device is designed to provide more efficient delivery, capture and recovery, while still allowing interventionalists to use their interventional wire of choice. Improvements over the current device include a complete rapid exchange system, 6 Fr. guide catheter compatibility and a unique dual-end delivery/recovery catheter with a preloaded capture wire.
The SPIDER and SpideRX Embolic Protection devices are investigational devices limited by federal law to investigational use in the U.S.