Navigation Links
Significant Reduction in Pain With the Mynx Vascular Closure Device Versus Angio-Seal Device
Date:3/8/2011

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 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.

About AccessClosure

Founded in 2002, AccessClosure, Inc. is a privately held medical device company pioneering innovative access site management products designed to provide a reliable, patient-friendly vascular closure experience.  The Mynx device utilizes an extravascular water-soluble polyethylene glycol (PEG) sealant that is gently deployed at the surface of the femoral artery.   Following deployment, the sealant immediately expands sealing the common femoral artery and tissue tract.  The sealant dissolves within 30 days, leaving nothing behind but a healed artery.  The Mynx received its first FDA approval in May 2007, has been used in over 750,000 procedures, and is available in two sizes for 5F and 6F/7F procedural sheaths.  For more information, visit our website at www.accessclosure.com.

*This study was an independently run physician-initiated study.   AccessClosure, Inc. had no input into data collection, analysis or presentation. The study was funded in part by a scientific research grant from AccessClosure, Inc.


'/>"/>
SOURCE AccessClosure, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Georgia Health Sciences University Clinical Study Shows RyMed InVision-Plus® IV Connector Significantly Decreased Central Venous Catheter Occlusions in Oncology Patients
2. Leading Animal Stem Cell Developer MediVet-America Achieves Significant Business Growth Milestones in First Year
3. The New England Journal of Medicine Publishes Results of Fidaxomicin Phase 3 Trial Showing Significantly Lower Recurrence Rates and Improved Global Cure Rates Compared to Vancomycin in Patients with Clostridium difficile Infection (CDI)
4. Structured Diabetes Management can Significantly Improve Overall Glycemic Control and Reduce HbA1c Values in Non-insulin Treated Type 2 Diabetes
5. Integrated Analysis Demonstrates Alpha(1)-Augmentation Therapy Significantly Reduces Loss of Lung Tissue in Patients with AAT-deficiency-related Emphysema
6. US Dominance in Scientific Research Significantly Challenged by Increased Competition from Europe and Asia, According to Thomson Reuters Study
7. YM BIOSCIENCES REPORTS SIGNIFICANT RESPONSE RATES IN ANEMIA, SPLENOMEGALY, AND CONSTITUTIONAL SYMPTOMS FROM THE PHASE I/II TRIAL OF ITS JAK1/JAK2 INHIBITOR, CYT387, IN MYELOFIBROSIS
8. STALLERGENES : Significant Growth : Q3 2010 + 10% and +12% Over the First 9 Months / Shionogi Partnership: First EUR24 Million Instalment
9. Spherix Announces Statistically Significant Results in Phase 3 Study With D-tagatose in Type 2 Diabetes
10. Cord Blood America Says Outreach Program to OB/GYN Nurses, Insurance Case Workers, Paying Significant Dividends
11. Teriflunomide Significantly Reduced Annualized Relapse Rate and was Well Tolerated in MS Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 Epic Sciences ... detects cancers susceptible to PARP inhibitors by targeting ... cells (CTCs). The new test has already been ... in multiple cancer types. Over 230 ... damage response pathways, including PARP, ATM, ATR, DNA-PK ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering with experienced ... this eBook by providing practical tips, tools, and strategies for clinical researchers. , ...
(Date:6/23/2016)... TORONTO , June 23, 2016 /PRNewswire/ - ... Ontario biotechnology company, Propellon ... the development and commercialization of a portfolio of ... cancers. Epigenetic targets such as WDR5 represent an ... contribute significantly in precision medicine for cancer patients. ...
(Date:6/23/2016)... (PRWEB) , ... June 23, 2016 , ... ... Plate® YM (Yeast and Mold) microbial test has received AOAC Research Institute approval ... of microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory ...
Breaking Biology Technology:
(Date:6/2/2016)... NEW YORK , June 2, 2016   The ... (Weather), is announcing Watson Ads, an industry-first capability in which ... advertising, by being able to ask questions via voice or ... Marketers have long ... with the consumer, that can be personal, relevant and valuable; ...
(Date:6/1/2016)... , June 1, 2016 ... in Election Administration and Criminal Identification to Boost Global ... a recently released TechSci Research report, " Global Biometrics ... Region, Competition Forecast and Opportunities, 2011 - 2021", the ... billion by 2021, on account of growing security concerns ...
(Date:5/20/2016)... MINNEAPOLIS , May 20, 2016  VoiceIt ... technology partnership with VoicePass. By working ... user experience.  Because VoiceIt and VoicePass take slightly ... two engines increases both security and usability. ... expressed excitement about this new partnership. ...
Breaking Biology News(10 mins):