"We expected to receive questions from the MEB which we believe is typical of most initial submissions," commented Casciaro. "We are working expeditiously to respond to their questions. The opportunity for Custom NX in select non-U.S. markets, including Europe and Asia-Pacific, remains significant and attractive, and we are exploring strategic options related to the distribution of Custom NX in these markets."
Casciaro added, "In the U.S., we are engaged in ongoing discussions with the Food and Drug Administration (FDA) in order to obtain approval of our application for an investigational device exemption (IDE) to commence pivotal trials. We have established an agreed upon timeline of deliverables and, while we believe we are on track to receive approval of our IDE application before the end of 2008, we now expect to commence our pivotal trials in 2009."
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(R) 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. Note: XTENT(R) Custom NX(R) DES Systems have not been approved for sale by any regulatory authority.
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: XTENT's expec
|SOURCE XTENT, Inc.|
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