ev3 Inc. Issues Durability Guarantee For its EverFlex(TM) Self-Expanding Stents
PLYMOUTH, Minn., Oct. 23 /PRNewswire-FirstCall/ -- Displaying confidence in the durability of its EverFlex Self-Expanding Stents, ev3 Inc. has announced a worldwide fracture-free guarantee in support of its new EverFlex family of stents. In the event that an EverFlex stent should fracture within two years of implantation, ev3 will provide a free replacement product to the medical facility, subject to the terms and conditions of the program.
The guarantee was announced today at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
Jim Corbett, President and CEO of ev3 Inc., commented, "While advances in stent technology have greatly improved treatment options for patients, industry data has shown that the potential for stent fracture remains a real clinical challenge. With the EverFlex stent, we have directly responded to this challenge with a unique product design that we believe will withstand even the most challenging clinical situations. And we are standing behind that belief with our new fracture-free product guarantee."
The EverFlex family of products was engineered to provide unmatched durability in a highly flexible platform, representing a significant advance in nitinol self-expanding stent technology. In rigorous simulated fatigue testing conducted by both ev3 and an independent testing facility, ev3's EverFlex stent demonstrated a 5 to 10 times improved resistance to fracture compared to the five competitive stents tested. Since its worldwide commercial launch in March 2006, ev3 has sold thousands of EverFlex stents worldwide.
"Clinical experience has shown that stent design is a critical indicator of performance," said Robert Minor, Jr. M.D., Director of Endovascular Interventions, OSF Saint Anthony Medical Center, and Director of the Rockford Cardiology Research Foundation, Rockford, Ill. "I believe that the EverFlex stent represents a notable advancement in stent technology, delivering the best strut fracture resistance available. The benefit this provides to both patients and the healthcare system is significant."
The EverFlex product difference lies in its unique design, which features: * Spiral cell interconnections that greatly enhance flexibility. * New wave peak structure that more efficiently distributes stress and resists compression. * Longer lengths (up to 150 mm and all 6 French compatible), which minimizes the need for overlapping stents when treating long lesions.
Designated as "one of the most significant new product launches in the peripheral stent and stent graft industry," ev3's EverFlex stent earned the company the 2006 Frost & Sullivan Product Innovation Award.
ev3's EverFlex guarantee is open to customers worldwide. Enrollment in the program is automatic upon implantation. To report a fracture and request free replacement product, the medical facility must provide ev3 with proof of the fracture within 30 days of observation. All requests will be reviewed by an independent Clinical Events Committee commissioned by ev3. The product guarantee does not apply if the EverFlex is used with additional overlapping stents.
The EverFlex Self-Expanding Stent System is indicated in the United States for the palliative treatment of malignant neoplasms in the biliary tree. ev3 also obtained CE Mark for the EverFlex for general use in the peripheral vasculature, including the iliac, subclavian and superficial femoral artery. ev3 has initiated a vascular trial, DURABILITY, in the EU and expects to initiate a clinical trial in the U.S. in the second quarter of 2007. These trials are intended to collect further clinical data on the performance of the EverFlex technology and to expand approved indications.
About ev3 Inc.
ev3 is a global medical device company focused on catheter-based technologies for the endovascular treatment of vascular diseases and disorders. For more information, please visit http://www.ev3.net.
ev3, the ev3 logo and Protege are trademarks of ev3 Inc., registered in the U.S. and other countries. EverFlex is also a trademark of ev3 Inc. This press release contains other trademarks and trade names of ev3 Inc. and other third parties, which are the property of their respective owners.
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; delays in regulatory approvals and the introduction of new products; and the timing and success of clinical testing. More detailed information on these and additional factors which could affect ev3 Inc.'s operating and financial results is described in the company's filings with the Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q and annual report on Form 10-K. 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.ev3 Inc.
CONTACT: Patrick D. Spangler of ev3 Inc., CFO, +1-763-398-7000,email@example.com, or Marian Briggs or Nancy A. Johnson of Padilla SpeerBeardsley, +1-612-455-1700
Web site: http://www.ev3.net/