Nuvasive Neodisc...

[JK2234]

Lets talk about it..

[Justin]

A 2009 Poster Presentation about the NeoDisc Cervical Total Disc Replacement: NeoDisc Cervical TDR: Correlation between Disc Height Increase and Clinical/Radiographic Success



NeoDisc™ Cervical Disc Replacement
Link

Advancing motion preservation through soft fixation. The combined elastic material andembroidery technology of NeoDisc™ provides a variety of surgical options, including interbody and ligamentous, in motion preservation applications. NeoDisc™ consists of three parts.

• A solid silicone core, containing no silicone gel, that acts like a cushion similar to a normal intervertebral disc.
  
• An encapsulating jacket formed from a polyester textile which is manufactured using computer controlled embroidery technology.
  
• Standard titanium alloy bone fixation screws.
  
• NeoDisc is designed to allow for motion maintenance at the surgical site.
  
• NeoDisc is fully imaging compatible, so it will not interfere with your surgeon’s examination of the implant.
  
• NeoDisc’s materials have proven, positive clinical results for use in orthopaedic implant applications.
  
• The NeoDisc surgical procedure is similar to the anterior cervical discectomy and fusion (ACDF), a very familiar surgery to your doctor.

Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease (This study is ongoing, but not recruiting participants.)

Also, there is information on the Nuvasive NeoDisc Website.

I hope this helps.

[jss]

Because this device allows spinal movements on the axial and coronal planes (like the M6) and because it was one of the precious few trials that accepted patients with adjacent fusions, I tried to get in on this trial in September 2008. I declined pursuing admission into the trial when I discovered that it was a double blind study; meaning that I had a 50% chance of waking up with a NeoDisc and a 50% chance of waking up with a third cervical fusion.

I have contacted The Texas Back Institute trying to get information on the progression of this trial. Since the trial's contact has ignored my attempts to contact him, I can't report on how it's going.

I think that this device has a lot of promise, and I'm anxious to see the numbers when the trial completes in October 2010.

[JK2234]

Wow! I think this might be the future, and possibly better then the M6 but idk yet..

[JK2234]

Ok im ready to have my pro disc taken out and replaced with one of these.

[Katie]

So far, I'm completely happy with mine...better than new, I think. But finding someone to do the surgery may be an issue. I had to go to Brazil for mine, and I only knew that I was getting an ADR that did not have any metal. Dr. Pimenta first spoke of a ceramic disc, but switched to the Neodisc just before I went down for surgery.

I would do it again in a heartbeat though. It is brilliantly simple and seems to suit me just fine

[sportsnut3007]

A great device held up by the fda, got to love em. I could be wrong, but i dont think a cervical adr to fusion is that hard especially compared to lumbar. Do fda employees have to sign a waver not to get products they vote not to approve? Also, I bet a dr in the states woulddnt mention adrs to a patient, but yet if he/she needed a neck fusion he/she would be on the first plane to europe to get this or the m6. Now some good drs would mention this to patients, but idk if they are held liable for mentioning non fda approved devices. Also, I wonder if ones with center keels could replaced by this one. Also, with I the pro disc one that patent lawsuit in regards to maverick with the center keel issue. Which, I dont think its right to have a patent stand up just bc of a center keel if that holds, then God help us with the freedom and spinal kinetics ones. At least this one doesnt have a central keel so no issues in patent law on that, and I wonder if nuvasive looking at this type of device for lumbar using ex lateral instead of just their metal one. I also wonder if this could be used to replace a cervical adr that had a central keel.

[JK2234]

When will this be used in the U.S.A? FDA?

[tyler]

According to NuVasive's corporate filings, they recently completed their U.S. clinical trial for NeoDisc and are in the process of seeking FDA approval for one- and two-level cervical ADR. I haven't found much published info but there was a presentation on a subset of patients (n=96) at the 2009 Annual Meeting of AAOS (American Academy of Orthopedic Surgeons) - text below. They also suggest that avoiding over-distraction during implantation is a predictor of success.

NeoDisc seems like a less-disruptive implant - but it's also radically different in design - basically a silicone pad within a polyester sleeve. I just wonder what effects the adjacent vertebrae and other stresses would have on the sleeve over time. I'm trying to find out more from docs who participated in the clinical trial and/or patients. Apparently Dr. Luiz Pimenta and others have implanted (outside of the U.S.).

2009 AAOS Annual Meeting Poster Presentations
·NeoDisc Cervical TDR: Correlation between Disc Height Increase and Clinical/Radiographic Success
Poster Presentation Number: P370
Location: Venetian/Sands EXPO Hall D
Spine

Randall F Dryer, MD Austin TX
William Blake Rodgers, MD Jefferson City MO
Scott H Kitchel, MD Eugene OR
Jim A Youssef, MD Durango CO
Kenneth A Pettine, MD Loveland CO
Title: It is not preoperative disc height which dictates the likelihood of success, but rather the adequacy of decompression and stabilization without overdistraction.

It has been suggested that patients with degenerative cervical spondylosis with significant associated disc space collapse may not achieve significant clinical success from TDR. It is also thought that increasing disc height by oversizing the implant results in poorer outcomes. Data from the US IDE NeoDisc trial were evaluated to highlight the clinical and radiographic results with respect to disc height (DH).

A subset of 96 patients from 5 NeoDisc trial centers who received the NeoDisc device (both randomized and training cases) were evaluated for clinical (NDI, VAS neck&arm) and radiographic (ROM) results at 6(n=59) and 12(n=32) months post-op. Correlations between DH and each outcomes measure were made, and average improvements in each were calculated for the categorical groups representing <1mm versus 1-2mm DH increase from pre- to post-op.

As a whole, clinical outcomes for the NeoDisc group were excellent: by FDA standards of 15-point change in NDI score, 87% showed clinical success at 6months, 91% at 12months. Neither clinical nor radiographic measures correlated with change in DH: r2NDI=0.017, r2VASn=0.002, r2VASa=0.000, r2ROM=0.011. Average NDA improvement was not different between the <1mm and 1-2mm DH increase groups at 6months (65.8% vs 62.2%) or 12months but trended toward increased function in the smaller DH increase group (78.8% vs 49.9%). Similar results were shown for VASn (59.8% vs 57.8% at 6months; 76.8% vs 46.6% at 12months) and for VASa (74.0% vs 55.2% at 6months; 80.0% vs 59.9% at 12months). ROM was more improved in the <1mm DH increase group at both timepoints (29.6% vs -4.2% at 6months; 24.7% vs 6.1% at 12months).

This data shows that while all patients do well clinically, a trend toward decreased ROM exists with greater disc distraction. However, it is felt that adequacy of decompression and stabilization without overdistraction is a greater predictor of clinical success than preoperative disc height.

[Katie]

Tyler, I think this is great news for cervical patients.

I had consulted with Dr. Fabien Bitan in NYC almost a year before I had my surgery with Dr. Pimenta. He was very alarmed at the state of my C5/6 and said I was one fall away from quadraplegia, the compression on my spine was so bad.

My symptoms were in part: complete numbness of my hands and arms when I tried to use them...a pins and needles feeling like when your leg goes to sleep after being crossed too long. This happened when I tried to type or paint (I'm a full-time artist & instructor). I had positive Hoffmann's sign, had bladder and bowel problems, could not walk a straight line nor walk on my heels or toes. The list goes on.

Three days after surgery, all symptoms were gone. Several excellent surgeons had warned me that surgery would only stop progression of my symptoms, most likely not reverse them. Thankfully that was not the case.

I am truly blessed that my symptoms came at a time when new technology was making these discs available and that we were able to travel for it. With the NeoDisc now being close to approval, it opens up a whole new option for spine patients.

Just as an aside, Dr. Pimenta travels frequently to California and may be an option as a surgeon if you live near there. I believe he has been in on the ground floor of the development of this disc.