Closys Hemostatic Device (HD) A Second Generation Vascular Closure Device
The CloSys Hemostatic Device (CloSys HD) represents the best of the Second Generation vascular closure devices. First generation VCD’s characterized by the use of active foreign materials such as collagen, thrombin and sutures, complicated deployment procedures and high costs were never able to capture the hearts and minds of the cardiology community in spite of the fact that several studies have demonstrated increased catheterization laboratory productivity and increased patient satisfaction. Safety concerns coupled with high costs and steep learning curves prevented universal acceptance of rapid closure.
The Second Generation is Coming…
Today, designers of Second Generation VCD’s are taking giant steps toward delivering a more “ideal” closure product. Second Generation devices use have no intravascular components ( a major concern among non-VCD users), do not use active materials and are much easier to learn to use. With the exception of the CloSys HD, costs have not been significantly reduced however.
Closys Corporation has addressed each concern of users and non-users of VCD by designing an elegantly simple, safe and cost effective closure that provides times-to-hemostasis and times-to-ambulation that compare favorably to current second generation devices.
Closys Corporation is currently conducting a U.S pivotal trial in four institutions. The trial is expected to be completed in the first quarter of 2010. A successful European trial was completed in mid-2008.