Healthcare Industry News: vascular closure
News Release - November 9, 2006
Successful Results of the 'Randomized, Prospective, Multi-Center Trial' for the MedClose(TM) VCSSARASOTA, Fla., Nov. 9 (HSMN NewsFeed) -- CPC of America, Inc. (OTC Bulletin Board: CPCF ) reports that its subsidiary, Med Enclosure, LLC, continues to report successful results with no adverse affects in both diagnostic and interventional clinical patients of the "Randomized, Prospective, Multi-Center Trial of the MedClose(TM) VCS." Comments from clinical investigators, heart catheterization laboratory technicians and nurses, recovery nurses, observing physicians, cardiology department heads, hospital administrators and patients have been positive and encouraging. Early data and results suggests that MedClose(TM) VCS may eliminate the need to wait before pulling the sheath following interventional cases. If this trend continues as the study progresses, it suggests that MedClose(TM) VCS could represent an important enhancement to the gold standard of manual compression.
The "Randomized, Prospective, Multi-Center Trial of the MedClose(TM) VCS" is a "non significant/low risk" device determined by both a US Independent Review Board and a Canadian Independent Review Board with subsequent approval by the Canadian Health, Health Products and Food Branch, Therapeutic Products Division for Protocol #CL-7000 is intended to seal femoral arterial puncture sites and reduce time to hemostasis and ambulation in patients who have undergone interventional and diagnostic catheterization procedures. The "non significant/low risk" determination recognizes that the MedClose(TM) plug- mediated vascular closure Device ("VCD") as an alternative to manual compression does not present a "significant risk" per 21 CFR 821.3(l)(m), and the MedClose(TM) VCS and the FDA licensed biologic fibrin plug does not meet the definition of an "implant." The fibrin plug is resorbed within "10-14" days. The MedClose(TM) and the delivered fibrin plug are not intended for use in supporting or saving lives, or for the purpose of diagnosing, curing, mitigating, or treating disease, or preventing impairment of human health. The FDA licensed biologic fibrin plug does not present a potential for serious risk to health, safety, or welfare of a subject. The Company upon completion of its "Randomized, Prospective, Multi-Center Trial of the MedClose(TM) VCS" expects to submit applications for both the CE Mark and Pre Market ("PMA") by Q2/2007.
The MedClose(TM) VCS is a proprietary catheter based system that uses existing FDA/CE Mark approved licensed biologic fibrin sealant with appropriate approved existing labeling to rapidly seal arterial puncture sites following diagnostic angiography, interventional cardiology and radiological procedures. MedClose(TM) VCS as stated above has been available for human use in clinical trials as "non significant/low risk" device but is not presently available for commercialization. MedClose(TM) VCS is the proprietary property of Med Enclosure, LLC, a subsidiary of CPC of America, Inc (OTC Bulletin Board: CPCF ) of Sarasota, Florida. CPC of America, Inc. has been developing cardiology medical devices since 1996 with its subsidiaries CPCA2000, Inc. and Med Enclosure, LLC. In 2003 the Center for Devices and Radiological Health ("CDRH") approved the CPCA2000, Inc. device with broad labeling as a Class III medical device.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks and uncertainties, and actual circumstances, events or results may differ materially from those projected in such forward-looking statements. Factors that could cause or contribute to differences include, but are not limited to, the risk that the FDA may not approve the PMA application for MedClose(TM) or, if approved, that any such investigation may be unfavorable; that that CPC may be unable to obtain FDA approval for commercial sale of MedClose(TM); and the risk that CPC may be unable to obtain capital as and when needed. For a discussion of these and other factors, which may cause actual events or results to differ from those projected, please refer to CPC's most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. CPC of America, Inc cautions readers not to place undue reliance on any forward-looking statements. CPC does not undertake, and specifically disclaims any obligation, to update or revise such statements to reflect new circumstances or unanticipated events as they occur.
Source: CPC of America
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