May 9 2012
The company is pleased to announce that after receiving Ethical Committee (EC) and Ministry of Health (MOH) approval, for the first human use of the company's FastSeal® Bioabsorbable Vascular Access Closure System, Phase I of the First in Human (FIH) clinical testing has been completed, with 100% successful results, and no adverse effects, including post procedural discomfort. The average Time to Hemostasis (TTH) was less than one minute. The clinical cases included vessels that were normal, diseased, severely fibrosed and with calcified plaque.
The initial series of human clinical cases were performed on Percutaneous Coronary Intervention (PCI) patients, by Prof. Alessandro Bortone of the Policlinico di Bari, University of Bari School of Medicine (IT). Phase II testing will begin within the next two weeks.
The detailed FIH test results will be presented at multiple upcoming medical conferences.
The company is planning to begin International commercialization (pending regulatory approval) during the fourth quarter of this year.
Source:
Vascular Closure Systems, Inc.
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