December 10, 2012 — Vascular Closure Systems Inc. announced the successful conclusion of Phase I and Phase II of the first-in-human (FIH) clinical trial for its 6/7 French FastSeal Bioabsorbable Vascular Access Closure System, achieving a 100 percent 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, patient comfort with the system was reportedly 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 cases were performed by Alessandro Bortone and Emanuela de Cillis of the Policlinico di Bari, University of Bari School of Medicine, Italy.
Videos of FIH cases are available to view at 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 United States, pending regulatory approval) of the 6/7 French system during the second quarter of 2013.
For more information: www.vclosure.com