PALO ALTO, Calif.--(BUSINESS WIRE)--Vascular Closure Systems, Inc.:
30-Day Follow-Up Results of the First in Human (FIH) Clinical Test Series of the FastSeal® Bioabsorbable Vascular Access Closure System – 100% Success Rate, Including Patients with Challenging Anatomy and Vessel Condition.
The company is pleased to announce that the 30-Day follow-up results for the Phase I FIH clinicals have been perfect, as confirmed by doppler and ultrasound evaluation. The evaluation confirmed normal vessel healing, with complete absorption of the FastSeal® sealing element. During the follow-up, no adverse events were observed - no hematoma, pseudoaneurysm or fistulas were present in any of the patients. All patients were asymptomatic and the comfort of the device was excellent, with no groin pain during the deployment, immediately after, at 7, and 30-days after the procedure.
A video of our FastSeal® Bioabsorbable Vascular Access Closure system being used during a First in Human (FIH) clinical case is available at the following link: http://vclosure.com/fihfastsealpatientncwmv.php
The initial series of human clinical cases were performed by Prof. Alessandro Bortone of the Policlinico di Bari, University of Bari School of Medicine, Italy. Phase II of the FIH clinical tests are currently underway.
The detailed Phase I and Phase II FIH clinical test results will be presented at multiple upcoming medical conferences.
A second manufacturing facility (outside of the US) has been set up and is producing FastSeal® Bioabsorbable Vascular Access Closure systems. Initially, the units being produced are for clinical testing to support regulatory submissions. Once regulatory approval has been granted, the units being produced at this site will be for commercial use.
The company is planning to begin International commercialization (outside the US, pending regulatory approval) during the fourth quarter of this year.
The Company is currently exploring multiple strategic options to enhance shareholder value, including, but not limited to, private funding, a possible strategic alliance, a merger or sale of the company.
Our FastSeal® Bioabsorbable Vascular Access Closure System is intended for use following a diagnostic or therapeutic, interventional cardiology or interventional radiology procedure, and 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® 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® system has the ability to be removed after deployment (if desired), without causing trauma to the vessel or requiring a surgical intervention.
About Vascular Closure Systems, Inc.
Vascular Closure Systems, Inc. is a privately held medical device company, based in part on the early and established intellectual property of CardioVascular Technologies, Inc. (http://cvtechinc.com), and is focused on the development and commercialization of the next generation vascular access closure technology for the Interventional Cardiology market. The company is comprised of several seasoned medical device professionals and world class physicians, with a proven record of innovation, clinical acumen, access to the industry and successful commercialization of multiple medical device technologies.
Please note that the company's devices have not yet been approved by the US FDA and are not currently for sale or use in the US.
The company is represented by Casey McGlynn of Wilson Sonsini Goodrich & Rosati.
Additional information is available at: www.vclosure.com