Vascular Closure Systems, Inc, First in Human (FIH) Use of the FastSeal(R) Bioabsorbable Vascular Access Closure System -- 100% Success Rate, Including Patients with Challenging Anatomy and Vessel Condition.
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(R) 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.
About FastSeal(R)
Our Bioabsorbable Vascular Access Closure System is packaged and used as a single piece unit, with no assembly required prior to use, and no separate deployment device is needed to be inserted into the puncture site. Simply insert the FastSeal(R) system into the hub of the procedural introducer sheath, and advance the attached plunger. The system design enables hemostasis within less than a minute after the non-collagen sealing element has been deployed. Our system doesn't require the use of a specific type or brand of vascular introducer sheath, and is compatible with any commercialized vascular introducer sheath with a useable length of between 10 to 12 cm. Once the sealing element has been deployed, no external compression is required. The inner vessel section of the sealing element is absorbed within 10 to 14 days. The remainder of the sealing element is completely absorbed within 21 days. The FastSeal(R) system has the ability to be removed after deployment (if desired), without causing trauma to the vessel or requiring a surgical intervention.
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