MENLO PARK, Calif., Apr. 3 /PRNewswire-FirstCall/ -- XTENT, Inc. today announced the enhanced configuration of the company’s Custom NX(TM) Drug Eluting Stent (DES) system was used successfully in its ongoing CUSTOM III clinical trial in Europe. The company also announced that its U.S. pivotal trial is on track to begin with this system in the second half of 2007 as planned.
The upgraded system features a smaller crossing profile and an improved user interface designed to further enhance stent placement accuracy and ease of use while decreasing procedure time, complexity and cost.
“I am very excited about this improved design. In my initial clinical experience with this enhanced design, the new Custom NX DES system is more intuitive and easier to use,” said the CUSTOM III Trial’s principal investigator Bernard De Bruyne, MD, PhD, Cardiovascular Center, OLV Hospital, Aalst, Belgium, who has completed multiple clinical cases with the new system. “It allows for easier delivery, particularly in tough-to-reach anatomic locations.”
The ongoing CUSTOM III clinical trial is designed to evaluate in situ stent customization for single focal lesions, long lesions or multiple lesions using XTENT Custom NX DES Systems. The study seeks to enroll 90 patients at up to 15 European centers. Enrollment is expected to be completed in the first half of 2007.
“I believe the newer system improves on the advantages of the prior system, such as accurate delivery of stents for treatment of today’s complex lesions, including long and multiple lesions, which are not easily addressable by today’s technology,” added De Bruyne. “The NX Delivery System with integral post-dilatation capabilities has the potential to allow for decreased case time and reduced equipment utilization which should lead to much-needed cost savings for cath labs in the future.”
About the Custom NX DES System
Custom NX is designed to enable a more personalized approach to arterial disease based on each patient’s individual lesion characteristics, improving ease of use and placement accuracy while decreasing procedure time.
The Custom NX system consists of a series of DES segments, allowing physicians to customize the stent length while inside the patient’s affected arteries. Physicians can shorten, reposition and reinflate the delivery balloon at the treatment site for post-dilatation if necessary. After the first stent deployment, the Custom NX can be reset and used to treat additional lesions. As a result, the Custom NX has the potential to treat single, long and multiple lesions with one device. In comparison, current fixed length systems often require multiple stents, balloons and catheter exchanges. More than half of stent patients have lesions in more than one vessel and approximately one in four procedures involve overlapping stents. Custom NX is the only DES system designed specifically to treat these patients.
XTENT Custom NX DES Systems have not been approved for sale by any regulatory authority.
About XTENT
XTENT, Inc. is a medical device company focused on developing and commercializing innovative customizable drug eluting stent (DES) systems for the treatment of coronary artery disease (CAD). CAD is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. XTENT(R) Custom NX(TM) DES Systems are designed to enable the treatment of single lesions, long lesions and multiple lesions of varying lengths and diameters, in one or more arteries with a single device.
Information on XTENT including an animation of the procedure can be found at www.xtentinc.com/news/downloads.php.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding XTENT’s business that are not historical facts may be “forward-looking statements” that involve risks and uncertainties. Specifically, these statements include, but are not limited to those concerning: the results of the CUSTOM III trial; XTENT’s intention to commercialize any of its products; XTENT’s ability to begin its pivotal U.S. trial in the second half of 2007; the ability of XTENT to enroll the anticipated number of patients in its CUSTOM III trial and to complete enrollment in that trial during the first half of 2007. Forward-looking statements are based on management’s current, preliminary expectations, and are subject to risks and uncertainties that could cause actual results to differ from the results predicted and which are included under the caption, “Factors Affecting Future Operating Results,” in the “Risk Factors” section of our most recent annual report on Form 10-K for the year ended December 31, 2006. This annual report was filed with the SEC on April 2, 2007, and is available on our investor relations website at www.xtentinc.com and on the SEC’s website at http://www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. XTENT undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
XTENT, Inc.
CONTACT: investors, Tim Kahlenberg, Chief Financial Officer,+1-650-475-9400, tkahlenberg@xtentinc.com; media, Danielle Bertrand, MediaRelations, +1-415-946-1056, dbertrand@weisscommpartners.com, both forXTENT, Inc.
Web site: http://www.xtentinc.com/
