Dear Friends,
It's been an amazing road that has brought me here. SAS6 is the fourth Spine Arthroplasty Society annual congress and the tenth major surgeon's conference I've attended since my ADR surgery almost four years ago. There is no way for me to express how incredible these days are... 100% immersed in SPINE... 7am till midnight most days absorbing information from all of the world leaders in spine arthroplasty. If it still moves... it's here!
There is way too much to report on, but I'll do my best. Mark's Blog is a new feature on the GPN site and it's fitting that SAS is the first event 'blogged'.



Technology Disclaimer
The devices, procedures, etc... discussed on this site are in various stages of development. While some have been proven safe and efficacious, are FDA approved and widely available; others may be in a wide range of developmental stages. Some are proven and are just waiting for FDA approval of the manufacturing process, which is expected very soon. Some are exciting ideas that may prove to be very bad ideas; possibly even harmful disasters. Some represent brilliant ideas that may ultimately become life-saving products while others will never make it to the marketplace. Even for the great products, development / testing / approval process may take years or even decades. There is no guarantee that any information presented here is correct. Items discussed here may never be available to the patient community. Medical decisions should not be made based on information found here.
iSpine Lending Library coming soon!!!
SAS Proceedings: Symposia Handouts, Abstracts of Podium Presentations and Poster Presentations
Day 1 - Wednesday May 10, 2006

07:00 Registration. I was very sorry to have missed the "Scientific pre-courses" yesterday. There were great sessions by some industry GIANTS. My first item on the agenda was to discover news about ProDisc approval. Bad news. I spoke to several ProDisc surgeons and Synthes execs who all told me: there will be no such announcement. Oh well... not to worry. I spoke to many who are in the know and the word on the street is that ProDisc will be approved 'soon'.

The morning consisted of Industry Workshops - breakout session. These are always tough decisions because there are nine different ones to choose from... all excellent. I decided to attend the session on Cryolife BioDisc, a new injectable nucleus replacement. The already have a pilot in Scotland with 10 patients that will be completed this month. Very exciting technology, but still very early. Please read the technology disclaimer above.
The second breakout session I chose was for a facet arthroplasty solution: TOPS (TOtal Posterior Arthroplasty) by Impliant Ltd. It has been interesting for me to watch the facet replacement systems come out of the closet. At SAS3 in Phoenix, they were invisible (to me.) At SAS4 in Vienna, they were certainly there, but did not have much of a presence. At SAS5 in New York, they were front and center, with systems being introduced in the general sessions. Clearly, they were still very early in the process. In Montreal, they were able to present results, films, even videos of patients. Very exciting technology, but still very early. Please read the technology disclaimer above.

Alternative statistical testing demonstrates superiority of lumbar arthroplasty clinical outcomes at 2 years vs. fusion for the treatment of one-level lumbar degenerative disc disease at L4-5 or L5-S1. Fred H. Geisler, MD, PhD

This session wins the award for longest title, but look how accurate the title is. With the current landscape of CMS (Medicare) and private insurance companies refusing to pay for the FDA approved Charite' lumbar artificial disc, this paper was an attempt to correct the deficiencies in the 'non-inferiority' study design of the Charite' clinical trial. As designed, that study set out to prove what it was designed to prove; that clinical results with the Charite ADR are NOT WORSE than fusion results. J&J blazed the trail for the US ADR market and much was learned about how not to present data to the FDA. There was much criticism of the Charite' data by the medical community, some of it well-meaning and some of it was competitive market forces trying to slow progress of the competitors devices that had years' head-start. (Unfortunately, this has worked, and much to the chagrin of thousands of spine patients, many of our lives have been severely impacted by such tactics.) Over and over again, I've seen them accused of hiding the data of the training cases. I personally know this to be unwarranted because I've seen the complications in the training cases reported over and over again at SAS, NASS, AAOS and other surgeons' congresses.

For the 'repackaged' data, they have included all of the training cases and have used different analysis tools. I've spoken to some statistics experts about the various tests available and the ones used for the original submission and for this second pass. I believe that this is not 'massaging the data'. I believe that, especially with the training cases added, this is a more accurate representation of the data.

The original submission using the protocol-specified student's t-test reported statistical significance between the randomized groups at 6 weeks, 3, 6, and 12 months, with no statistical significance at 24 months. Reporting on ALL cases and using the Wilcoxon Rank Sum Test, the data "demonstrates that lumbar arthroplasty with the Charite' Artificial Disc at one level for treatment of DDD, results in significantly superior clinical outcomes at all time points through the 2-year follow-up, compared to fusion using well recognized and validated outcome scoring methods (ODI and VAS)."

Note from Mark: Apparently, this approach has worked. On May 16th, CMS issued a "Coverage Decision Memorandum for Lumbar Artificial Disc Replacement" that reverses it's previous decision denying coverage for the Charite' ADR. It's early to jump for joy, if you read the memorandum, you'll find that they are not endorsing the treatment or agreeing to pay. They are just not denying it at the national level. It will be up to local Medicare/Medicaid officials to determine coverage.

Read J&J's press release on the iSpine website.

Read the entire CMS memorandum at the CMS website.

Day 2 - Thursday May 11, 2006

One of the highlights of the conference was bumping into Dr. Rick Delamarter early in the morning. Over a cup of coffee, I showed him a slide show called 'New Beginnings' made by a patient of his. Set to fantastic music, it tells the story of an incredible rebirth... going from a life of pain, fear, meds and disability before surgery... then on to traveling, skiing, just living and loving life again (in the manner that only Paulette can achieve!) The smile on his face as he took it all in was wonderful. After this, we chatted for a while as he tried to relate how wonderful it is for him to be able to see broken people come back to life. Thanks Paulette and Dr. Delamarter for allowing me to participate in this process!

Day 4 - Saturday May 13, 2006

Because I have several cervical clients with substantial cord compression with myelopathy, I was on a mission to gather more information about their situations and options. Rebound Myelopathy (Braintalk post)