Barricade Annular Prosthesis from Intrinsic Therapeutics

[mmglobal]

One of the benefits of what I do is that I'm frequently able to see the technologies develop from close range. There are many exciting new intra-discal treatments that look VERY promising. Various prosthetic disc nucleus designs (PDN) have been tried. Stem cell treatments, autologous disc chondrocyte transplantaton (ADCT), growth factor injections, fibrin injections, ozone injections (something I'll be studying over the next few weeks) and a seemingly endless variety of discectomy/decompression procedures have also been tried in many iterations through the years. Sadly, for many (if not most) of us, by the time we get to having surgery, we are too far down the degenerative cascade for us to be good candidates for these procedures. If if the disc and annulus are too severely compromised, our chance for success is substantially reduced.

Some of the exciting technologies that I've seen developing over the years are annulus repair techniques. While most of the procedures I mentioned above work well in some cases, for the patients with more severely degenerated discs, the failure rate is way too high. If they can REPAIR the annulus, the incidence of recurrent herniations will be substantially reduced. The risk of migration or expulsion of a prosthetic disc nucleus will be greatly reduced. These procedures will be more accessible to more patients... those who are currently relegated to ADR or fusion procedures.

A over the last few months, I was able to observe implantation of the Barricade Annular Prosthesis from Intrinsic Therapeutics of Woburn, MA. This may be a very significant breakthrough as the procedure is so straightforward, finishing a discectomy with an annular repair adds only a few minutes to the procedure.

Through the years, it's been frustrating to watch new technologies that are introduced, make so much sense, look so promising; then they just fade away. Companies with annular repair techniques have been at the conferences for many years now. There have been sewing techniques, 'pop rivets' and other attempts at annular repairs. While the early buzz is great, I've not seen any widespread acceptance. Some of these techniques may be improved upon or may pan out as time goes on. Other new devices will be developed with deficiencies of the early devices designed out of them. Hopefully, the Barricade will be successful. It's easy to use and seems to provide an effective and secure barrier against recurrent herniations. Time will tell.

The Intrinsic Therapeutics website has a great video that clearly depicts what the procedure is like. I have some photos from their website and some of their new literature below.

All the best.

Mark

[mmglobal]

more images...

[GOCP]

As you mentioned, many just fade away. It's a tough area and many have tried approaches such as this. With the FDA rejecting them again for poor clinical outcomes, it will be interesting to see what other companies will attempt to solve this low percentage reherniation issue.

[Crystal33]

Regarding the importance of preserving annular integrity, this study showed progressive loss of disc height following discectomy reaching 26% by end of two years. No doubt the decrease in disc height would have continued after the study.
A prospective cohort study of close interval compu... [Spine (Phila Pa 1976). 2009] - PubMed result

Recently the following study was published, presenting a modified suturing technique that has been tested to effectively close annular defects, promote annular healing, and delay/prevent disc height loss and degeneration following discectomy. Five Phd researchers were involved in the development and testing.

The Effect of a New Anular Repair After Discectomy in Interv... : Spine

There is also currently a Phase III clinical trial under way of the X close annular repair system by Anulex.
Anulex: Preservation and Anular Repair

I wonder whether these annular repair techniques might also be compatible with the numerous biologic gels and tissues developed in recent years that promote sealing and healing of annular defects. Combining the physical and biological approaches might facilitate a very fast healing and strong repair allowing the patient to get back to their life without risk of needing a future ADR or fusion due to progressive disc collapse.

Also, percutaneous nucleus replacement might become a desirable procedure where annular integrity can be assured.

As these approaches would not be as lucrative as fusion or ADR there may be limited motivation for industry to develop or pursue them.