I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: MooseMom on February 09, 2012, 10:09:22 AM
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CE Mark Clearance for Vital Access's Implantable Hemodialysis Access Device
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SALT LAKE CITY, Feb. 8, 2012 /PRNewswire/ -- Vital Access Corporation today announced that its Venous Window™ Needle Guide has been granted CE Mark clearance for use in Europe to provide vascular access for hemodialysis treatment, the most common treatment method for patients with advanced kidney failure.
As a result of CE Mark clearance, Vital Access™ has begun initial efforts to ramp-up sales and marketing in Europe for its Venous Window Needle Guide. "This is a major milestone that our team has been focused on since the inception of the company. This approval allows us to begin selling in over 30 countries in Europe and to expand access around the world," stated Doug Smith, President and CEO of Vital Access. He added, "Most important, we are excited to provide solutions to kidney failure patients to help in their struggle to maintain and improve their dialysis access sites."
The Venous Window Needle Guide is a subcutaneously implantable medical device that is surgically attached to the top of an Arteriovenous (AV) Fistula to provide a palpable target beneath the skin. When used, the Venous Window Needle Guide acts as a funnel directing a dialysis needle to the patient's AV Fistula. The Venous Window Needle Guide's opening at the AV Fistula surface allows the needle to directly access the vessel utilizing the Buttonhole Technique which has been demonstrated to minimize vessel damage.
Vital Access was granted CE Mark clearance for its Venous Window Needle Guide following successful implantation and repeated cannulation during its First in Human clinical trial conducted at sites in New Zealand. Leading the clinical trial as Principal Investigator was Dr. Andrew Hill, MBChB, FRACS.
United States Clinical Trial
Vital Access is currently conducting a pivotal IDE trial in the United States called the SAVE Trial (Vital Access Venous Window Needle Guide for Salvage of AV FistulaE). For more trial information on the Vital Access IDE trial, please refer to www.clinicaltrials.gov.
About Vital Access
Vital Access Corporation, founded by Dr. Duane Blatter MD, is a privately held medical device company located in Salt Lake City, Utah that specializes in technologies to improve vascular access. For more information, please call 801-433-9390.
© 2012 Vital Access Corporation. All Rights Reserved. Vital Access and Venous Window are trademarks of Vital Access Corporation.
Vital Access Contact
Doug Smith, 801-433-9390
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It looks like they are still recruiting for the study here in the US if anyone is interested in volunteering.
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Indeed it does look promising. I can hardly wait to hear more about it.
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I am hearing about this for the first time on this thread (i.e. no connection to me). Here is a link to more info about the clinical trial:
(Trials appear to be in Fresno, CA and Tulsa, OK.
http://www.clinicaltrials.gov/ct2/show/NCT01471041?term=vital+access&rank=1 (http://www.clinicaltrials.gov/ct2/show/NCT01471041?term=vital+access&rank=1)
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I am hearing about this for the first time on this thread (i.e. no connection to me). Here is a link to more info about the clinical trial:
(Trials appear to be in Fresno, CA and Tulsa, OK.
http://www.clinicaltrials.gov/ct2/show/NCT01471041?term=vital+access&rank=1 (http://www.clinicaltrials.gov/ct2/show/NCT01471041?term=vital+access&rank=1)
I am confused, perhaps even concerned. The principal investigator seems to be some man with a bachelors of the arts. What doctor is overseeing these studies?
Have clinical trial regulations been relaxed to this point? I wouldn't participate in a trial that was being run by someone with only a BA. Call me a snob, but it is your access we're talking about.
(Does make me wonder which art he studied to earn that degree....)
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Actually Mark has a very impressive resume. Seems he has been in the medical device field for over 30 years on the technical side (engineering patent etc). http://www.linkedin.com/pub/mark-crawford/5/55b/aa7
He looks like he's worked his way to the top. Besides he's the Study Director kind of like the Project Manager. And no, there have been no lapse in running clinical trials if anything its gotten harder. The FDA will need to approve his plan and validate the data, no getting around that.
Bill
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I take your point, Bill, but he is down under 'investigators' and is the only name listed there. Who is the PI and shouldn't that person be an MD? Not so much for analysis of data and general coordination but to serve as the medical professional who will intervene to handle any access issues.
It would make me nervous but then I am not even totally sure what this device does, so maybe there are no medical risks. I'd find that hard to believe though.There are always risks. Glad regs remain strong!
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Hi,
I noticed this thread a while ago and wanted to inform you that the SAVE (Salvage of Aneurysmal Fistulae) Study has concluded and has been published in the peer-reviewed Journal of Vascular Surgery. Here is a link to a press release from Vital Access Corporation announcing the publication: http://www.prnewswire.com/news-releases/vital-access-corp-announces-publication-of-vwing-pivotal-trial-results-262377131.html
Of note in this discussion was a concern about Mark Crawford's role in the SAVE Study. To clarify, Mark Crawford is the VP of Clinical Affairs at Vital Access and helped to organize the study. He was not a Principal Investigator. The principal investigators of the study included surgeons and nephrologists at 11 different study sites across the United States. Dr. William Jennings, the principal investigator for the Tulsa, Oklahoma study site, was the primary author of the Journal of Vascular Surgery SAVE Study summary. The full text of the publication is available at the following link: http://www.jvascsurg.org/article/S0741-5214(14)00764-2/fulltext
For answers to any other questions related to the VWING Vascular Needle Guide, please visit the Vital Access website (www.vital-access.com) or speak with your physician.