Vascular Closure Systems, Inc. Announces the Successful Completion of the First in Human (FIH) Clinical Trial of the 6 Fr. / 7 Fr. FastSeal® Bioabsorbable Vascular Access Closure System. 100% Success Rate With Exceptional Time to Hemostasis (TTH) and Time to Ambulation (TTA). The FIH Clinical Trial Results Demonstrate Superior Safety, Ease of Use, Performance, Patient Comfort and Cost Effectiveness.
***The Company is planning to begin International commercialization (outside the US, pending regulatory approval) of the 6 Fr. / 7 Fr. system during the second quarter of 2013.
SOURCE: Vascular Closure Systems, Inc., www.vclosure.com
Full press release follows.
PALO ALTO, Calif.--()--(Dec. 4, 2012)--Vascular Closure Systems, Inc.:
The Company is pleased to announce the successful conclusion of Phase I and Phase II of the First in Human (FIH) clinical trial for our 6 Fr. / 7 Fr. FastSeal® Bioabsorbable Vascular Access Closure System, achieving a 100% success rate throughout both phases of the clinical trial, with exceptional Time to Hemostasis (TTH) and Time to Ambulation (TTA). The clinical trial included patients with challenging anatomy and vessel condition. Additionally, the patient comfort with the system was excellent, with no groin pain during the deployment of the sealing element, immediately after, and throughout the vessel healing process. The post deployment follow-up evaluation (including echo doppler) confirmed normal vessel healing, without inflammation, and complete absorption of the FastSeal® sealing element.
The FIH clinical trial results are as follows:
Phase I (10 patients, all diagnostic cases)
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TTH
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TTA
| ||||||
| (min:sec) | (hrs:min) | ||||||
Time
| 1:13 | 6:40 Hrs. | |||||
Std. Dev.
| 0:40 | 2:44 | |||||
Phase II (20 patients total, 15 PCI cases)
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TTH
|
TTA
| ||||||
| (min:sec) | (hrs:min) | ||||||
Time
| 0:43 | 2:14 Hrs. | |||||
Std. Dev.
| 0:34 | 1:07 | |||||
The FIH clinical trial cases were performed by Prof. Alessandro Bortone, and Prof. Emanuela de Cillis of the Policlinico di Bari, University of Bari School of Medicine, Italy.
Videos of FIH cases are available to view at the following link: http://vclosure.com/fastsealvideos.php
The detailed Phase I and Phase II FIH clinical trial results will be presented at multiple upcoming medical conferences.
The Company is planning to begin International commercialization (outside the US, pending regulatory approval) of the 6 Fr. / 7 Fr. system during the second quarter of 2013.
Additional Versions of Our FastSeal® System
An 18 Fr. version of our FastSeal® Bioabsorbable Vascular Access Closure system has been designed, developed and successfully tested, for the nonsurgical deployment of large diameter / large bore transcatheter therapeutic devices, such as Transcatheter Aortic Valve Implants / Replacements (TAVI / TAVR) and Endovascular Aneurysm Repair (EVAR) devices. These additional versions of our technology will in the future enable us to offer solutions for these rapidly growing market segments. The Company has also designed and is developing a non-absorbable closure system for left ventricle transapical access procedures. A video showing our large bore vessel closure system sealing an 18 Fr. puncture, is available to view at the following link: http://vclosure.com/fastseal_bioabsorb18wmv.php
All versions of our FastSeal® Vascular Access Closure systems have been designed in close collaboration with our world-class medical advisors.
About the FastSeal® Product
Our FastSeal® Bioabsorbable Vascular Access Closure System is intended for use following a diagnostic or therapeutic, interventional cardiology or interventional radiology procedure. The 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® 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 (such as Cordis, St. Jude Medical, Terumo, etc.). 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 being deployed (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 and Interventional Radiology markets. 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.
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. The current funding round will close in the near future.
The Company is represented by Casey McGlynn of Wilson Sonsini Goodrich & Rosati.
Jim Heslin (Wilson Sonsini Goodrich & Rosati) has taken the lead on the maintenance and prosecution of the Company’s Intellectual Property (IP).
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.
Additional information is available at the Company’s website: www.vclosure.com
Contacts
Vascular Closure Systems, Inc.
Russ Houser, CEO, +1 925-371-1029
Investor Relations:
ir@vclosure.com
General Information:
info@vclosure.com
Russ Houser, CEO, +1 925-371-1029
Investor Relations:
ir@vclosure.com
General Information:
info@vclosure.com
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