MOUNTAIN VIEW, Calif., March 9, 2011 /PRNewswire/ -- AccessClosure, Inc., the U.S. market segment leader in extravascular closure devices, announced today results from the first published study* (Journal of NeuroInterventional Surgery) comparing the pain associated with deployment of different vascular closure devices (VCD) as the primary endpoint. The single-blinded, randomized, single-center, controlled trial compared the discomfort associated with the Mynx 5F Vascular Closure Device versus the Angio-Seal Evolution Device. Both pain at closure and the pain increase from baseline to closure were significantly higher in patients undergoing closure with the Angio-Seal Evolution device (p=0.009 and 0.002, respectively). There was no difference in the rate of closure success or closure complications between the devices.
"This is an important study for physicians and patients,'' said Gregory D. Casciaro, President and CEO of AccessClosure. "The study scientifically examined whether the Mynx device reduced the pain associated with arteriotomy closure seen with the Angio-Seal Evolution device and provides an evidence-based understanding that will help guide choice about VCD options."
The Institutional Review Board-approved study provided for enrollment of 128 patients based on power analyses with the intention of performing preliminary statistical analysis following enrollment of 64 patients (32 patients in each arm). Patients, nurses administering a commonly utilized, well-validated visual analog scale (VAS) to assess patient pain, and study coordinators were blinded to the VCD treatment. The primary end point was defined as the change in pain from baseline (pre-closure) to post-closure, assessed by the VAS. The patient's reporting of the most painful part of the procedure from a multiple choice selection (1. Lidocaine injection and access, 2. contrast injection and 3. closure) was a secondary endpoint along with
|SOURCE AccessClosure, Inc.|
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