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.
Founded in 2002, AccessClosure, Inc. is a privately held medical device company pioneering innovative access site management products designed to provide a reliable, patient-friendl
|SOURCE AccessClosure, Inc.|
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