DRX 9000 Spinal Decompression

I received several emails from patients that google the table DRX 9000 and some have asked me about the isues the company has, I posted a recent letter from Axiom whom makes the table.
I do not work for them but I do believe that it is the best table on the market, this is the table I use in my Manhattan practice www.drshoshany.com
If you are considering getting spinal decompression I recommend you get treated on the DRX 9000. New York Spinal Decompression.
Herniated Disc Center visit www.nycdisc.com



March 24th, 2007
TO OUR VALUED CUSTOMERS:
During the past several months many negative stories regarding Axiom and the DRX9000TM havebeen disseminated throughout the medical profession. In a very real sense we have aided incirculating these stories by our failure to respond to and/or refute them. So please allow me toapologize. Axiom will certainly take some of the blame for this. We have been quite silent andliving in a private vacuum as we worked to address some of these issues. We fully realize thatthis has in turn further caused and aided in some of this confusion and we want to say that we aresorry for the lack of communication and direction. We also want you to know that this willnever happen again and this is part of our new customer service pledge to you!
Many of you know that Axiom has been involved in litigation. While our competitors may chooseto fight these battles via different public mediums, we have opted out of such gamesmanship.Additionally, under the advisement of our legal counsel we have not commented on many of theissues. With Axiom falling silent as we assess the landscape, we shoulder this blame ofconfusion and again we apologize. However, now we feel that we should no longer remain silenton the issues confronting us so I offer the following on various subject matters:
PatentsIncorporated into the design of the DRX9000TM are more than thirty (30) critical components thatare protected by existing patents or patent applications held by our suppliers. Fifteen (15) of thesecritical components are unique and specialized to the DRX9000TM and are integral in achievingTrue Non-surgical Spinal DecompressionTM. We have agreements with each of the suppliers ofthese critical parts that assure that the parts can not be used in any other spinal decompressiondevice. Our exclusive agreements with our suppliers have allowed us to pass this security andprotection along to our customers as no other spinal decompression manufacturer can utilize theseunique component parts.Furthermore, in December 2004, Axiom applied for its own patent on the DRX9000TM. In June2006, the United States Patent Office published Axiom's proposed patent. This patentapplication may be viewed at: http://appft1.uspto.gov/netahtml/PTO/search-bool.html
Simply type in Axiom and Worldwide to view each published patent application. Axiom has also filedseveral other patent applications and we will soon inform you of their respective developments.
FDAThere are a total of four FDA 5 10 (k) clearances as Class II medical devices assigned to our DRXproducts. The first clearance was obtained on May 1, 2001 for our original design theDRX2000TM under 510(k) number K010292. The second clearance was on the DRX3000TM andwas obtained on January 23, 2003 under 510(k) number K022602. The third clearance wasobtained on December 20,2002 for our cervical product, the DRX5000TM. This clearance isunder 510(k) number KO23160. The fourth clearance was obtained on May 26,2006 for ourDRX9000TM True Non-Surgical Spinal Decompression SystemTM. This clearance is under 510(k)number K060735. Axiom follows and complies with all FDA regulatory requirements. This doesnot mean that the FDA has endorsed Axiom's products. It simply means that Axiom hasfollowed the proper procedures to be allowed to commercially distribute its products. To viewour latest 510(k) please visit: http://www.fda.gov/cdrh/pdf6/K060735.pdf
In the past Axiom, along with other medical device manufacturers, from time to time used theterm "FDA Approved" to describe its 510(k) cleared device. Axiom took steps to make certainthat its marketing materials referenced that its 510(k) cleared products were "FDA cleared" sometime ago and our doctors have been sent new marketing kits which further clarifies that issue.The FDA routinely conducts on-site audits of medical device manufacturers and their marketingmaterials. If there's a problem, a warning letter is issued. After Axiom's last inspection in 2006,there were no warning letters issued. Nonetheless, Axiom has removed all references to "FDAApproved" from its advertising. The removal of "FDA Approved" from our advertising and ourrecommendation that our customers also remove "FDA Approved" is an attempt on our part toimplement a very conservative approach to advertising, one that avoids scrutiny, and an effort tokeep our doctors out of the disputes.
The "86% Success Rate" Different state regulatory agencies have challenged the study which was published in OrthopedicTechnology Review. The authors cite an overall 86% success rate. These state agencies contendthat this is not a valid study based on their standards. Obviously we are contesting this positionand investigating the issues raised. The study itself describes a specific course of treatment of 219 patients and indicates that they were treated according to a recommended protocol with treatment success being further defined as a reduction in pain via a pain scale. The removal of "86%" from our advertising and our recommendation that our customers also remove "86%" is again, an effort to implement a very conservative approach to advertising which is beyond reproach and to keep our doctors out of the dispute.
As a DRX9000TM Doctor, you know better than anyone that the machine works. There is agrowing amount of clinical documentation which demonstrates the effectiveness of theDRX9000TM. We feel the science behind non-surgical spinal decompression is becoming morewidely established and accepted every day. We agree that new and more controlled studies areimportant. As a result new clinical testing is currently ongoing. A separate press releaseregarding the status of ongoing research will be forthcoming.
NASALet's make no mistake about it, the NASA topic is a hot button and it deserves a properexplanation. The "NASA issues" and the comments being broadcasted over the internet havetaken a life of their own. We want you to understand Axiom's position with respect to this yet todo so here would add way too much additional information to an already long letter. Soon, aseparate press release regarding NASA will be forwarded to you. Please be on the look out for it!
THE PLAN MOVING FORWARD STARTS HERE. As Axiom grew, we got involved with many different relationships that were brought to us. We have found that we can not control the content of what they put out into the marketplace. We are not in a position to approve or even have knowledge of all of the information that has been put out there that was created by these third parties. It is simply impossible. Therefore, Axiom will no longer participate or endorse or whatever you may want to call it, anythird party originated marketing material or support.
This letter is being sent to you as a brief explanation of recent events and Axiom's response to therumors flying around. This is not an advertising document; it is a simple explanation. Pleasediscontinue the usage any old or third party media supplies. We urge you to only use the newmarketing kit which you recently received. These kits include new TV Commercials,Infomercials, In-Office DVD's and brochures that have been reviewed and vetted by Axiom'sattorneys. These marketing materials represent the first installment of many new marketing toolsAxiom will be providing in the next few months. If you do not have one, or have a question thenplease contact Axiom's marketing department. As always, it is incumbent upon you to checkwith your state boards to ensure local compliance.
An Important Note: Before I close this letter I feel it is important to describe some of the past. Therefore, with yourindulgence, I wish to present the following facts as mere highlights to some of the things that wehave experienced by our competitors' efforts to derail Axiom's growth. They have hired variousprivate investigators at different times to pose as doctors in order to gain entrance into Axiom'sfacility to learn about our sales processes and they have tape recorded phone conversations. Theyhave also hired them for other reasons still unknown, yet we continue to investigate. Ourcompetitors have even entered into various "business" relationships with some of our formersales reps and in that process have obtained confidential information and conspired in collusionwith one another to the detriment of Axiom in ways that we are still learning about.
Several months ago, various state agencies have challenged some of our doctors on marketingclaims related to advertisements being utilized. It's important to note that Axiom was not a partyto these proceedings and that we were specifically asked to not get involved. Nonetheless,Axiom is now involved in the proceedings and is doing everything it can to address the issues. More recently, two weeks ago the Federal Government executed a search of Axiom's premises as part of an investigation. Obviously Axiom is cooperating fully and more information will be released as we learn more and if permitted.
Exciting Improvements as We Look Ahead: I say "we" because I want each and every one of you to succeed. We heard that you want bettercommunication. We heard you want more quality marketing; marketing that is both effective andreflects the quality and credibility of your practice and the DRX9000TM. We heard you want moreresearch; studies by top doctors from prestigious universities that will help eliminate theskepticism that some have about this technology, and let patients know they don't have to live inpain anymore and that they have options other than surgery.
The issues raised in this letter are Axiom's battle. We want to keep it that way. Once again, Ipersonally value the relationship established with each and every customer and I will personallystrive to insure better communication with you. In an effort to get a handle on how some of theseevents were affecting our doctors, I had some Axiom team members travel around the country,visit with and contact our doctors and hear, first hand, what we can do to better serve you. We gotan earful. We heard you loud and clear and we promise to communicate in a more timely fashion.
Recently we even sent one of our team members to some of your offices to directly interviewpatients on camera. What was gleaned from this trip were many video taped testimonials frompatients successfully treated on the DRX9000TM. We will add these tapes to our library which isnow in excess of 300 patient testimonials. We heard patients talk about how they were told theironly option was surgery, then they discovered the DRX9000TM and it changed their life. But morethan anything, we heard this: We heard doctor after doctor talk about how the DRX9000TM isproviding amazing results and helping them treat patients they could never help before.
As President and CEO of Axiom Worldwide, I want you to know I am committed to make thishappen. If you have a question that you can't seem to get answered, if you have a problem thatnobody within Axiom has been able to address, then please email me at
President@axiomworldwide.com
I assure you that in spite of recent events, the DRX9000TM works and Axiom is here to stay. Thenext few months will be a very exciting time for our DRX9000TM doctors. We look forward tosharing several major new developments with you, in the weeks and months to come.
Warm regards,
James J. Gibson, Jr.President & CEOAxiom Worldwide, LLC


Comments: I really think this letter is great, Several months ago Jet blue airlines had problems wit flight cancelations and delays and the CEO wrote a similar letter and set a standard with airline policies and procedures.
This letter will help patients and Doctors realize Axiom is sponsering trials and clinical studies that the industry needs to continue to prove the technique is valid and the table is the gold standard when it comes to Non Surgical Spinal Decompression
www.drshoshany.com