PLYMOUTH, Minn., Nov. 1 /PRNewswire-FirstCall/ -- ev3 Inc. today announced that several ev3 clinical trials and products were featured at the respected Trans Catheter Therapeutics (TCT) conference held recently in Washington, D.C. The featured clinical trials included: The CREATE I Carotid Stent Trial utilizing ev3’s SPIDER(TM) Embolic Protection Device with the Protege(R) GPS(TM) Self-Expanding Stent; the CREATE II Carotid Stent Trial utilizing ev3’s next generation SpideRX(TM) Embolic Protection Device with the Guidant AccuLinkRX(TM) Stent; and the SPIDER Saphenous Vein Graft SVG Randomized Trial also utilizing ev3’s SPIDER(TM) and SpideRX(TM) Embolic Protection Devices. All three ev3 sponsored clinical trials presented at TCT were conducted in accordance with an Investigational Device Exemption (IDE) received from the U.S. Food and Drug Administration (FDA). The safety and efficacy endpoints in the clinical trials were met, and the results of the three trials have been, or will be, submitted to the FDA by ev3 in support of a requested approval. In addition to these clinical trials, a number of other marketed ev3 products, including the Invatec AMPHERION(TM) and Invatec SAILOR(TM) Balloon Dilatation Catheters and the Invatec DIVER C.E.(TM) and X-SIZER(TM) Thrombectomy Catheters, were highlighted at TCT during presentations and live cases.
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James Corbett, President and CEO of ev3 Inc., commented, “We are both excited and honored that ev3’s investment in, and commitment to, innovative and clinically effective products are being recognized at such a prestigious venue as the TCT conference. We look forward to receiving FDA approval of products such as the SpideRX(TM) and Protege(R) GPS(TM) so that we can make them available to endovascular specialists in the United States.”
The CREATE I and II clinical trials (Drs. Robert Safian and Gary Ansell, Co-Principal Investigators) were conducted to evaluate the safety and efficacy of the ev3 SPIDER(TM) and SpideRX(TM) Embolic Protection Devices and the Protege(R) GPS(TM) Self-Expanding Stent for the minimally invasive, endovascular treatment of high risk patients with carotid artery disease. The endovascular treatment of carotid artery disease involves placing a stent in the narrowed vessel after deploying a filter, or embolic protection device, in order to capture particles that may be dislodged during the procedure. The ev3 SPIDER(TM) Embolic Protection Device and the Protege(R) GPS(TM) Self- Expanding Stent met the safety and efficacy endpoints in the 419 patient CREATE I registry. Likewise, the SpideRX(TM) Embolic Protection Device utilized with the Guidant AccuLinkRX(TM) Stent met its safety and efficacy endpoints in the 160 patient CREATE II registry trial. This data will be submitted to the FDA in support of the product’s approval.
The SPIDER Saphenous Vein Graft (SVG) Randomized Trial (Dr. William O’Neill, Principal Investigator) was conducted to evaluate the safety and efficacy of the ev3 SPIDER(TM) Embolic Protection Device during the endovascular treatment of occluded saphenous vein grafts (SVG’s). During open heart surgery SVG’s (from the patient’s own leg) are utilized to “bypass” occluded coronary arteries. Prior to the advent of embolic protection devices, the endovascular treatment of occluded SVG’s was associated with complication rates as high as 20%. The SPIDER(TM) device met the safety and efficacy endpoints in the 732 patient randomized trial which required that the product be as effective as previously commercialized devices in preventing strokes or heart attacks in conjunction with the endovascular treatment of occluded SVG’s. This data will be submitted to the FDA in support of an approval as well. The SPIDER(TM) and SpideRX(TM) devices have a unique filter design made of nitinol, a metal alloy commonly used in endovascular products.
About ev3 Inc.
ev3 Inc. is a global medical device company focused on endovascular technologies for the minimally invasive treatment of vascular diseases and disorders.
ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries.
Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Such potential risks and uncertainties relate, but are not limited, to, in no particular order: product demand and market acceptance; the impact of competitive products and pricing; the success of clinical testing; and the receipt of regulatory approvals. More detailed information on these and additional factors which could affect ev3 Inc.'s operating and financial results are described in the company’s filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. ev3 Inc. urges all interested parties to read these reports to gain a better understanding of the many business and other risks that the company faces. Additionally, ev3 Inc. undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events.
** The SPIDER(TM) and SpideRX(TM) Embolic Protection devices are investigational devices limited by federal (U.S.) law to investigational use in the United States. The SPIDER and SpideRX(TM) Embolic Protection devices are not available for sale in the United States. This press release makes no representation about if or when the products discussed herein will be approved by the FDA.
SPIDER, SpideRX, Protege GPS and ev3 are trademarks of ev3 Inc.
AccuLinkRX(TM) is a trademark of GUIDANT Corporation
GUIDANT is a registered trademark of GUIDANT Corporation
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CONTACT: Patrick Spangler, CFO of ev3 Inc., +1-763-398-7000,pspangler@ev3.net
