The FX miniRAIL, which features two metal wires external to an angioplasty balloon, received CE Mark approval in December 2001 and is currently available in Europe, Asia Pacific, the Middle East and Africa. A pre-market approval (PMA) submission for the FX miniRAIL was filed with the U.S. Food and Drug Administration (FDA) in September 2002. The acquisition will be effective upon satisfaction of certain conditions, including U.S. regulatory approval of the device. Terms of the agreement were not disclosed. Once completed, Guidant expects the transaction to be non-dilutive.
"The FX miniRAIL's design will make it attractive for the treatment of in-stent restenosis and a variety of other clinical situations. The FX miniRAIL will also be attractive in conjunction with stenting and brachytherapy," said Dr. Martin B. Leon of Lenox Hill Hospital in New York City, who served as principal investigator for the IDE pivotal study for U.S. approval of the product.
"This acquisition supports Guidant's commitment to broadening Guidant's offering of innovative technologies to interventional cardiologists and their patients," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant Corporation. "We are enthusiastic about the potential of the FX miniRAIL, which complements Guidant's broad line of products for the treatment of coronary artery disease. We have been pleased with feedback on the value of this device from international clinicians and physicians involved in the device's clinical investigation."
"We believe that the features of our FX miniRAIL product line, combined with Guidant's established presence in interventional markets make this a compelling combination," said Guy Shinar, president and CEO of X Technologies. "The progress that we have made to date is a tribute to the outstanding efforts of our dedicated employees."
Guidant Corporation pioneers lifesaving technology, giving an opportunity for a better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information, visit www.guidant.com.
NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom.
This release includes forward-looking statements concerning the acquisition. The statements are based on assumptions about many important factors, including satisfaction of the conditions to closing described in the release (which depends upon, among other things, clinical and regulatory developments), future sales of the product and other factors identified on Exhibit 99.1 to the company's most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements.