The makers of the Viberect are working hard to constantly improve the product. Just so you know, the Dr. who invented the Viberec is not a get-rich-quick guy. I've met him and he's truly trying to help men that have been failed by the corporate medical world. The approval rate for the product is very high - but the key is all about expectations.
Anyway, they have made some improvements to the device to make it stronger and it is now even stronger than the "Ferti-care" which has been the only vibrator for nerve stimulation/regeneration for men with Spinal Cord Injuries - and the Ferticare costs 2-3 times more.
I will be sending more infor as I get more. I'm also going to write an article on it. I'll keep you posted.
We have been really interested in this device because there is growing evidence (some of it from you guys) that physical therapy for the penis is the direction that medicine needs to go. Drugs alone do not do the job. Pumps help, but exercise, stretching, blood flow and now, vibrational nerve stimulation (in hopes of nerve regeneration) seem to be the new frontier. (also, there are just no vibrators for men on the market - Period!)
I am working with two physicians on this and we are looking for funding to start a formal study on PT for the penis.
Paul
Update
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Worried Guy
- Posts: 28
- Joined: Sun Aug 02, 2009 4:40 pm
Re: Update
Paul,
Would the addition of some E-stim (like the internals from a simple TENS unit) be helpful? It seems like the Viberect has all the building blocks in place already.
J
Would the addition of some E-stim (like the internals from a simple TENS unit) be helpful? It seems like the Viberect has all the building blocks in place already.
J
Age 56, Gleason 3+4, BX 7/12 up to 70%, PSA 23 at DX May '09.
RP by DaVinci on July 21, '09 Both nerves gone. Incontinent.
Sling installed 1/2011 Works great. Now to fix ED.
RP by DaVinci on July 21, '09 Both nerves gone. Incontinent.
Sling installed 1/2011 Works great. Now to fix ED.
Re: Update
will those of us who purchased the original generation viberect be able to upgrade our units?
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Frank Talk Admin
- Site Admin
- Posts: 665
- Joined: Mon May 18, 2009 11:06 am
- Location: NYC
Re: Update
I would certainly call them and ask!
Let us know if you do
Paul
Let us know if you do
Paul
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Frank Talk Admin
- Site Admin
- Posts: 665
- Joined: Mon May 18, 2009 11:06 am
- Location: NYC
Re: Update
Here is the latest press release about the Viberect. Guys, when you get the new one, would you let me know your impressions? We want to know what you think. It helps us help other guys.
Thanks
Paul
Reflexonic Achieves FDA Clearance, CE Marking, and ISO 13485:2003 Certification for VIBERECT ED Device in Less Than a Year
June 26, 2012
Medical technology developer expands market for Viberect™ with support from Emergo Group
Chambersburg, PA (PRWEB) June 26, 2012
Reflexonic, LLC, the Chambersburg, Penn.-based medical device manufacturer that developed the Viberect non-pharmaceutical device for treatment of erectile dysfunction (ED), has achieved ISO 13485:2003 quality system certification and CE Marking in order to commercialize its product in the European Union.
The Viberect device targets men with mild to moderate ED symptoms, those undergoing post-prostatectomy erectile rehabilitation as well as those with spinal cord injuries causing ejaculatory dysfunction. Viberect™ functions via high-frequency and amplitude vibratory stimulation of penile nerves in order to activate sexual pathways leading to successful erection and ejaculation.
With support from Austin, Tex.-based medical device regulatory and quality assurance consultancy Emergo Group, Reflexonic has now implemented an ISO 13485-compliant quality management system required by European regulators, and has begun marketing Viberect in European territories. (The firm obtained US FDA 510(k) clearance to sell Viberect in the US six months ago, also with Emergo Group assistance.).
Since FDA clearance, there are several multicenter clinical trials underway for treatment of ED and spinal cord injury ejaculatory treatment using the Viberect showing high satisfaction and success, and pending publication. Canada, Australia, and Brazil licensing is pending. The Viberect is already licensed to sell in India, the Middle East, and most of Southeast Asia.
“Viberect is now the only therapeutic hand-held device for treatment of ED cleared for sale both in the US and EU,” says Dr. Kambiz Tajkarimi, Reflexonic Founder and President. “We were able to establish our ISO 13485 compliance and go through the CE Marking process with minimal complications by relying on Emergo Group's expertise.”
“Interest in noninvasive, physiological and non-pharmaceutical ED treatments such as Viberect will no doubt rise as more patients become aware of these treatments,” says Julie Powell, Vice President of Quality Assurance at Emergo Group. “Leveraging Emergo Group's support for ISO 13485 and CE Marking certification allowed Reflexonic to expand its presence from the US to Europe in less than a year.”
Stuart Goldman, Senior Consultant at Emergo Group, adds, “Taking on an ISO 13485 implementation plus CE Mark certification on your own can be prohibitively expensive and complicated for all but the largest medical device companies. By partnering with Emergo Group, Reflexonic now has access to the two largest medical device markets in the world.”
About Reflexonic, LLC
Reflexonic is an urologist-owned and operated US medical device company dedicated to creating simple, intelligent, and physiological hand-held devices that millions of men can use to restore and preserve their sexual and urinary health. Further information can be found at http://www.reflexonic.com
About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting. Further details at http://www.emergogroup.com
For additional information, please contact:
Reflexonic, LLC
Dr. Kambiz Tajkarimi, Founder and President
202-321-8162
Read more: http://www.benzinga.com/pressreleases/1 ... z1yuGrovff
Thanks
Paul
Reflexonic Achieves FDA Clearance, CE Marking, and ISO 13485:2003 Certification for VIBERECT ED Device in Less Than a Year
June 26, 2012
Medical technology developer expands market for Viberect™ with support from Emergo Group
Chambersburg, PA (PRWEB) June 26, 2012
Reflexonic, LLC, the Chambersburg, Penn.-based medical device manufacturer that developed the Viberect non-pharmaceutical device for treatment of erectile dysfunction (ED), has achieved ISO 13485:2003 quality system certification and CE Marking in order to commercialize its product in the European Union.
The Viberect device targets men with mild to moderate ED symptoms, those undergoing post-prostatectomy erectile rehabilitation as well as those with spinal cord injuries causing ejaculatory dysfunction. Viberect™ functions via high-frequency and amplitude vibratory stimulation of penile nerves in order to activate sexual pathways leading to successful erection and ejaculation.
With support from Austin, Tex.-based medical device regulatory and quality assurance consultancy Emergo Group, Reflexonic has now implemented an ISO 13485-compliant quality management system required by European regulators, and has begun marketing Viberect in European territories. (The firm obtained US FDA 510(k) clearance to sell Viberect in the US six months ago, also with Emergo Group assistance.).
Since FDA clearance, there are several multicenter clinical trials underway for treatment of ED and spinal cord injury ejaculatory treatment using the Viberect showing high satisfaction and success, and pending publication. Canada, Australia, and Brazil licensing is pending. The Viberect is already licensed to sell in India, the Middle East, and most of Southeast Asia.
“Viberect is now the only therapeutic hand-held device for treatment of ED cleared for sale both in the US and EU,” says Dr. Kambiz Tajkarimi, Reflexonic Founder and President. “We were able to establish our ISO 13485 compliance and go through the CE Marking process with minimal complications by relying on Emergo Group's expertise.”
“Interest in noninvasive, physiological and non-pharmaceutical ED treatments such as Viberect will no doubt rise as more patients become aware of these treatments,” says Julie Powell, Vice President of Quality Assurance at Emergo Group. “Leveraging Emergo Group's support for ISO 13485 and CE Marking certification allowed Reflexonic to expand its presence from the US to Europe in less than a year.”
Stuart Goldman, Senior Consultant at Emergo Group, adds, “Taking on an ISO 13485 implementation plus CE Mark certification on your own can be prohibitively expensive and complicated for all but the largest medical device companies. By partnering with Emergo Group, Reflexonic now has access to the two largest medical device markets in the world.”
About Reflexonic, LLC
Reflexonic is an urologist-owned and operated US medical device company dedicated to creating simple, intelligent, and physiological hand-held devices that millions of men can use to restore and preserve their sexual and urinary health. Further information can be found at http://www.reflexonic.com
About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting. Further details at http://www.emergogroup.com
For additional information, please contact:
Reflexonic, LLC
Dr. Kambiz Tajkarimi, Founder and President
202-321-8162
Read more: http://www.benzinga.com/pressreleases/1 ... z1yuGrovff
Re: Update
The first model was a peice of crap, the second one just plain works! Try it you will like it! 
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hoosierphilly
- Posts: 132
- Joined: Mon Mar 14, 2011 11:08 am
Re: Update
Review my posts of the ED1000 under new treatment in the general discussion....
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sleeptheclockaround
- Posts: 13
- Joined: Thu Jan 19, 2012 4:07 pm
Re: Update
My Dr suggested this.... Waiting for it to arrive in the mail
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