ev3 Inc., a privately held endovascular medical device company, has received CE Mark approval for the SpideRX™ Embolic Protection Device for use in peripheral, coronary and carotid vessels. The SpideRX is a next-generation product offering even greater ease-of-use than the SPIDER Embolic Protection Device, which received CE Mark approval in September 2002. The company plans to introduce the SpideRX throughout Europe in late July. Embolic protection devices are small filters placed within a blood vessel to capture and remove plaque particles dislodged during interventional procedures, such as angioplasty or stenting, to prevent stroke or heart attack.
"While the previously introduced SPIDER™ Device is a very competitive and well received product, the introduction of the SpideRX allows us to provide our customers with rapid exchange capability, a feature they have been asking for, without compromising ease of use or guidewire of choice," said Pascal Girin, general manager, ev3 Europe. Girin noted that many interventional physicians previewed the SpideRX Device during live cases at the Paris Course on Revascularization.
The SpideRX device, like its predecessor product, has a unique nitinol filter. (Nitinol is an alloy commonly used in interventional products.) The new 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, 6Fr guide catheter compatibility and a unique dual-end delivery/recovery catheter with a pre-loaded capture wire.
"The new SpideRX is truly a more simple and easy to use embolic protection system," stated Dr. Eugene McFadden, Thorax Center, Rotterdam, the Netherlands, after performing one of the first cases with the new device. "The ability to use a preferred guidewire to cross the lesion is a unique feature of this device and offering a preloaded device with rapid exchange delivery will make this a more competitive embolic protection product."
ev3 plans to introduce the SpideRX Device into ongoing clinical trials in the United States for saphenous vein grafts (SPIDER Trial) as well as use it with the
ev3 Protégé® GPS™ Nitinol Self Expanding Stent for carotid application.
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