ev3 Inc. Receives FDA Clearance For SpideRX(TM) Embolic Protection Device For Carotid Artery Stenting
PLYMOUTH, Minn., Feb. 17 /PRNewswire-FirstCall/ -- 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). This arm of the study was designed to evaluate the SpideRX rapid exchange Embolic Protection Device for use with the Guidant RX ACCULINK(TM) Carotid Stent System. The primary endpoint was defined as 30 day major adverse cerebrovascular and cardiovascular events (MACCE) including myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA or death. MACCE at 30 days for the SpideRX arm occurred in 5.6 percent of patients.
Dr. Gary Ansel, Riverside Hospital, Columbus, Ohio, national Co-Principal Investigator for the CREATE Trial stated, "The CREATE Trial data confirms the success and safety of the SpideRX Device for use in carotid stenting of patients at increased surgical risk."
Carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. When narrowing occurs, patients are at risk for stroke. Stroke is the nation's third leading cause of death, affecting nearly 700,000 Americans each year. Embolic protection devices are small filters placed beyond a blockage in the carotid arteries to collect debris released during stent placement to prevent a stroke or other neurological event.
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. Improvements over the Spider Over-the-Wire system include a complete rapid exchange system, 6 Fr. guide catheter compatibility and a unique dual-end delivery/recovery catheter with a pre-loaded capture wire.
Dr. Ansel also commented, "The SpideRX Device is unique in that it allows physicians to utilize their own wire system of choice, leading to consistent success in placing the embolic protection device during carotid interventions."
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.
ev3 Inc. is a global medical device company focused on endovascular technologies for the minimally invasive treatment of vascular diseases and disorders.
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, and success of clinical testing. 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 revision 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.
ev3 and the ev3 logo are trademarks of ev3 Inc., registered in the U.S. and other countries.
SPIDER, SpideRX, and ev3 are trademarks of ev3 Inc.
ACCULINK is a trademark of GUIDANT Corporation.
GUIDANT is a registered trademark of GUIDANT Corporation.ev3 Inc.
CONTACT: Patrick Spangler, CFO of ev3 Inc., +1-763-398-7000,firstname.lastname@example.org