CPC of America, Inc. (BULLETIN BOARD: CPCF), Sarasota, Fla.,
reports that its subsidiary, Med Enclosure, LLC, has submitted an
Investigational Device Exemption ("IDE") application to the
U.S. Food and Drug Administration for the MedClose(TM) Vascular Closure
System (MedClose(TM) VCS) in preparation for launching a pivotal U.S.
clinical trial. The MedClose(TM) VCS is a proprietary catheter-based
system that uses fibrin sealant to rapidly seal arterial puncture sites
following angiography and angioplasty. MedClose(TM) VCS is not presently
available for human use.
The clinical study of MedClose(TM) VCS, known as the F-A-S-T trial,
will be a randomized study involving diagnostic and interventional
patients versus manual compression, and will take place at five U.S.
sites. The F-A-S-T trial is expected to begin in the Q4 of 2005. Results
obtained from the F-A-S-T trial will be used to support a premarket
approval (PMA) application for the MedClose(TM) VCS.
MedClose(TM) VCS is the proprietary property of Med Enclosure, LLC,
a subsidiary of CPC of America, Inc (BULLETIN BOARD: CPCF.OB) of
Sarasota, Florida. Biomed Research, Inc. is a privately held corporation
that provides contract product research, development, manufacturing and
regulatory advisory services.
For more information, call 941/727-4370 or visit
http://www.cpca2000.com.
COPYRIGHT 2005 Worldwide
Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2005, Gale Group. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.