SARASOTA, Fla., Jan. 11 /PRNewswire-FirstCall/ -- CPC of America, Inc. reports that its subsidiary, Med Enclosure, LLC, continues to report successful investigational results for both diagnostic and interventional patients in the "Randomized, Prospective, Multi-Center Trial of the MedClose(TM) Vascular Closure System". Early results suggest differences in the time-to-hemostasis between diagnostic and interventional cases, with average times of 4.6 minutes and 15.3 minutes, respectively, which is consistent with expectations. When MedClose VCS was used to augment compression, introducer sheaths were pulled immediately after the procedure, even when activated clotting time (ACT) > 400 seconds, i.e. within minutes of discontinuing Bivalirudin. Investigators and support staff continue to comment positively regarding the ease of use by a single operator, suggesting hemostasis times in the presence of high levels of anticoagulation, and patient comfort associated with immediate sheath removal for which patients have made positive comments. The trend toward rapid sheath removal, especially following interventional procedures, suggests that MedClose VCS may represent a major enhancement to the existing gold standard of manual compression, and post-procedural care.
The MedClose(TM) VCS is a medical device, catheter-based, plug-mediated system that is designed to seal femoral arterial puncture sites and reduce time to hemostasis and ambulation in patients who have undergone diagnostic and/or interventional catheterization procedures. It utilizes a proprietary catheter system that is designed to enhance manual compression by delivering a CE Mark/FDA licensed biologic, which forms a fibrin plug that is fully resorbed within 10 to 14 days. Due to its rapid resorption, the delivered plug is not considered to be a permanent "implant". The MedClose VCS is not intended to support or sustain human life, nor is it intended to diagnose, cure, mitigate, treat or prevent impairment of human health. Consistent with the labeling and 10+ years of clinical experience for the CE Mark/FDA licensed biologic, the clinical investigational results for MedClose VCS supports that it does not present a potential for serious risk to health, safety, or welfare of a subject.
MedClose(TM) VCS is the proprietary property of Med Enclosure, LLC, a subsidiary of CPC of America, Inc 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") cleared the CPCA2000 Counterpulsation System 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 CPC may be unable to obtain FDA approval or acceptance in other countries 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.
CPC of America, Inc.