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.
“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 major and minor adverse events associated with VCD and closure.
As pre-specified, enrollment was terminated following analysis of the first 64 patients enrolled because of the statistically significant difference in comfort detected. The reduction in pain favoring the Mynx device compared to the Angio-Seal Evolution device was highly significant for both primary and secondary endpoints, which measured the pain at closure and the change in pain from baseline (pre-closure) to closure. Over twice as many patients undergoing closure by Angio-Seal closure as those undergoing Mynx closure reported the most painful part of the procedure to be VCD deployment (88% vs. 34%, p<0.001). The large difference in pain experienced between Mynx and Angio-Seal patients was hypothesized to be secondary to the presence or absence of compression elements within the devices. No major or minor adverse events were reported in patients undergoing either Mynx or Angio-Seal closure procedures, although the study was not powered to detect a difference in adverse complications.
"Patient comfort is an important aspect in selecting a vascular closure device and every step taken to improve the patient's experience is a step in the right direction," said Dr. J. Mocco, (Department of Neurosurgery, University of Florida College of Medicine, Gainesville, FL), co-author of the study.
The Mynx device is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. The Mynx device has not been approved for the reduction of pain in VCD procedures.
SOURCE : AccessClosure, Inc.