Navigation Links
XTENT, Inc. Receives Conditional Approval for Investigational Device Exemption of Custom NX(R) Drug Eluting Stent System from United States Food and Drug Administration
Date:6/4/2009

MENLO PARK, Calif., June 4 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced that the Company received conditional approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) authorizing it to begin its pivotal clinical program, composed of two pivotal trials called CUSTOM IV and CUSTOM IV Angio to support the approval in the United States of its Custom NX(R) Drug Eluting Stent (DES) System. The conditional approval requires the Company to address some technical issues about which the FDA has questions prior to granting full approval.

"This conditional approval further demonstrates the progress made in the development of a truly revolutionary drug eluting stent system," said Greg Casciaro, President and Chief Executive Officer of XTENT, Inc. "I want to recognize each and every XTENT employee, and especially Dr. Philippe Marco, our Vice President of Quality Assurance, Clinical and Regulatory Affairs, for their dedication and efforts in introducing a new drug and coating formulation along with a new delivery platform through this regulatory process. We also must credit the active participation and support of our BA-9/PLA licensor, Biosensors."

"This is a significant milestone for a technology that was designed to treat today's complex patient population that presents with multi-vessel coronary artery disease and/or long lesions," said Martin B. Leon, M.D., Associate Director of the Center for Interventional Vascular Therapy, New York-Presbyterian Hospital/Columbia University Medical Center. "It will be a missed opportunity if this technology does not carry forward in development quickly as it not only potentially fills the unmet clinical needs we have today, but it may also address the increasing cost pressures faced by the global healthcare system by potentially reducing the total procedural cost for coronary stenting."

"This is a bitter sweet announcement because of the timing," added Casciaro. "Although the Company's Board of Directors has approved a plan of complete liquidation and dissolution, we will continue to consider any reasonable alternative strategic proposals presented to us prior to the upcoming shareholder meeting."

The Company previously announced on May 15, 2009 that its board of directors has unanimously approved a plan of complete liquidation and dissolution of the Company subject to stockholder approval. XTENT intends to hold a special meeting of stockholders on July 9, 2009 at its principal offices located at 125 Constitution Drive, Menlo Park, California to seek approval of the plan of complete liquidation and dissolution.

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(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.

For further information, please visit our website at http://www.xtentinc.com/.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties concerning XTENT's proposed liquidation and dissolution and its products. Actual results may differ materially from the results predicted. We believe that these potential risks and uncertainties include the possibility that the FDA does not grant XTENT full approval for its clinical trial and that no reasonable strategic alternatives to the dissolution and liquidation of XTENT become available. Statements in this release should be evaluated in light of these important factors. More information about these and other important factors that could affect our business and financial results is included in the "Risk Factors" section of our quarterly report on Form 10-Q and the preliminary proxy, both of which were filed with the SEC on May 15, 2009.


'/>"/>
SOURCE XTENT, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. XTENT, Inc. Announces Approval of Plan of Liquidation and Dissolution by Board of Directors and Filing of Proxy Materials With the SEC
2. Cepheid Receives Health Canada License for Xpert(R) HemosIL(R) FII & FV Test
3. Innovia Receives FDA Clearance For The InnoPort(TM)
4. Cordex Receives Special Protocol Assessment Approval from FDA for ATPace(TM)
5. Respected Surgeon Receives Emmy Nomination
6. Edward Diehl Receives Outstanding Achievement Award From the American College of Addiction Treatment Administrators (ACATA)
7. LA BioMed researcher receives clinical teaching award
8. SAFC Pharmas St. Louis HPAPI Conjugates Facility Receives SafeBridge Certification
9. ALIMTA(R) (pemetrexed for injection) Receives Positive Opinion From CHMP as Maintenance Therapy for Nonsquamous Non-Small Cell Lung Cancer
10. Bausch & Lomb Receives FDA Approval of Besivance(TM), New Topical Ophthalmic Antibacterial for the Treatment of Bacterial Conjunctivitis (Pink Eye)
11. Family Health International Receives $100,000 Grand Challenges Explorations Grant for Innovative Global Health Research Project Led by David Sokal, M.D.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Rhinebeck, NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of ... of companies that call for a minimum wage raise to $12 an hour by 2020 ... wage. This will restore the lost value of the minimum wage, assure the wage floor ...
(Date:6/24/2016)... ... 24, 2016 , ... EB Medicine presented its first-ever “Issue ... conference in Ponte Vedra Beach, FL. The awards honor the outstanding work of ... and Pediatric Emergency Medicine Practice. , “With this award, we recognize the ...
(Date:6/24/2016)... Vegas, Nevada (PRWEB) , ... June 24, 2016 ... ... Las Vegas client, The Grove Investment Group (TGIG), has initiated cultivation and processing ... Grove, in Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of ...
(Date:6/24/2016)... ... ... recruitment firm Slone Partners is pleased to announce the placement of Suzanne ... of North American Capital Sales at HTG Molecular . , In ... commercialization of the HTG EdgeSeq system and associated reagents in North America. , Headquartered ...
(Date:6/24/2016)... ... June 24, 2016 , ... Today, MTI-GlobalStem, a provider ... and other difficult to transfect cells, announces its launch of the PluriQ™ G9™ ... Editing System is a complete system for culturing and transfecting human pluripotent ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... "The World Market for Companion Diagnostic Tests" report to ... World Market for Companion Diagnostics The World ... diagnostic and personalized medicine diagnostics. Market analysis in the report ... Diagnostics Test Market (In Vitro Diagnostic Kits) by Region (N. ...
Breaking Medicine Technology: