February 19, 2006

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February 19, 2006

February 19 – February 26

Feb 21st: Ev3 Receives FDA Clearance for SpideRX(TM) Embolic Protection Device for Carotid Artery Stenting.

Ev3 Inc today announced the 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.

FDA clearance was supported by a 160-patient high-risk carotid stent registry as part of ev3's CREATE Carotid Registry (which also included a 419-patient arm studying the Protege(R),GPS(TM) Self-Expanding Stent and the SPIDER(TM) Over-the-Wire Device). The CREATE Trial data confirms the success and safety of the SpideRX Device for use in carotid stenting of patients at increased surgical risk.

The SpideRX Device features a unique nitinol filter to capture embolic debris. The device is designed to provide efficient delivery, capture and recovery while allowing interventionalists to use their interventional wire of choice.

Jim Corbett, CEO of ev3, stated, "Clearance and commercialization of the SpideRX Device for use in carotid artery stenting is an important milestone as it allows ev3 to offer an alternative competitive embolic protection technology to our U.S. endovascular physician customers. Additionally, the SpideRX Device represents an important technology to ev3 as it materially broadens our peripheral and neurovascular portfolio."

The SpideRX Device is commercially available in Europe and several countries in Latin America and Asia.

Feb 22nd: Clinical Study Confirms Safety and Efficacy of Novel Germicidal Device to Help Prevent Hospital-Acquired Infections

Catheter site infections are among the most common and serious hospital-acquired infections. Hospital-acquired (nosocomial) infections affect 1 in 20 patients and kill more people than car accidents and homicides combined. In the U.S. in 1995, nosocomial infections cost $4.5 billion and contributed to more than 88,000 deaths-one death every 6 minutes.

UVSolutions (www.uvs-ultraclean.com) announces that data from a recently completed clinical study confirms its patented catheter site disinfection system (also patented for wound care) is safe and efficacious on the most sensitive skin. The disinfection system includes a palm-sized, battery operated, germicidal ultraviolet device placed over the catheter site to instantly deliver a single flash of UVC light through a proprietary dressing.

"UVSolutions' proprietary Catheter Site Disinfection System is instant and painless. This novel disinfection system will help prevent the buildup of microorganisms around the catheter site that cause infections with a single dose of germicidal UV light per day. UVSolutions LLC is a privately held product development company in Boston, Massachusetts. The Company licenses its proprietary products to market leaders.

Feb 23rd: Microchip Could Be a Lifesaver

In the future, patients arriving in the emergency room who need immediate access to their medical records may be armed -- literally -- with a tiny, high-tech helper.
More than 1,000 Americans have already volunteered to get a microchip about the size of a grain of rice embedded in their arms.

If a patient comes in and has the chip in their arm, the hospital's system will recognize them and pull up their entire medical record. The VeriChip, developed by Applied Digital Solutions, of Delray Beach, Fla., could help many of these patients, he said. The tiny chip, which costs about $200, is injected under the skin of the arm in a minimally invasive procedure that takes less than 20 minutes.

Experts stress that the chip itself does not contain the patient's medical records, just a 16-digit code that a hospital scanner picks up on. That digital identifier is then used to track down the patient's medical files via computer.

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