• Cardiac Science (Bothell, Washington) reported that the FDA has granted the company 510(k) regulatory clearance to market a new “crash cart“ defibrillator-monitor designed specifically for use by medical professionals to respond to cardiac emergencies in hospital settings. The new defibrillator will be sold exclusively by GE Healthcare (Waukesha, Wisconsin) to hospitals in the U.S. and Canada under the Cardiac Science Powerheart brand, and to customers outside North America under the GE Responder brand. Initial shipments are expected to take place during 2Q06. The new defibrillator-monitor is a lightweight, rugged and portable device with resuscitation and pacing therapies. Operators are guided by a combination of programmable text prompts, audible alarms and visible indicators. The defibrillator-monitor incorporates the company's STAR biphasic escalating shock energy technology, which automatically adjusts the magnitude of the defibrillation shock based upon each patient's body type and also employs Cardiac Science's RHYTHMx software, which provides heart rhythm analysis and shock advice to effectively address life- threatening arrhythmias.

• ev3 (Plymouth, Minnesota) reported FDA 510(k) clearance of the SpideRX Embolic Protection Device for use in carotid artery stenting applications. ev3 is prepared to release the product immediately for commercial sale. The device is designed to provide efficient delivery, capture and recovery while allowing interventionalists to use their interventional wire of choice. Improvements over the Spider Over-the-Wire system include a complete rapid exchange system, 6 Fr guide catheter compatibility and a dual-end delivery/recovery catheter with a pre-loaded capture wire.

• FoxHollow Technologies (Redwood City, California) reported that a multi-center evaluation of patients with critical limb ischemia found that 82% of patients who received plaque excision avoided an amputation or rece-ived a less-extensive amputation than originally planned. Results of the study were published in the February issue of the Journal of Endovascular Therapy. The patient population was comprised of those who suffer from the most severe form of peripheral artery disease (PAD). Six months after the plaque excision procedure, 96% of the lesions remained free from re-treatment in patients without amputation. Patients enrolled in the study were treated with the company's SilverHawk Plaque Excision System, a device used to remove plaque caused by PAD and restore blood flow to the legs, feet and toes.

No Comments