Drawn from the comprehensive worldwide spine surgery report #M520.
Nucleus arthroplasty is an emerging technology that allows replacement of only the nucleus of the degenerated disc using prosthetic devices, leaving the rest of the vertebral disc intact. It is becoming an additional surgical tool for selected cases of LBP due to DDD. Nucleus arthroplasty is designed to treat early stages of DDD, one of the most common spinal disorders in people under 65 years old.
In an article that appeared in the May 2011 European Spine Journal (2011 May;20 Suppl 1:S36-40. Nucleus disc arthroplasty with the NUBAC™ device: 2-year clinical experience), Balsano M, et al assessed patients who had undergone a nucleus arthroplasty and received a NUBAC™ (Pioneer Surgical) nucleus disc prosthesis. The manufacturer says that NUBAC is the first articulating nucleus disc prosthesis. It is constructed in two pieces of PEEK, with an inner ball and socket-type articulation. Optimal indications for implantation of the device are a disc height greater than 5 mm, early stage DDD at a single level, intact facet joints and failure of the usual conservative treatment. Of the 39 patients who underwent nucleus disc arthroplasty between December 2006 and January 2009, data showed that there were significant decreases in both Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) after the procedure, with a meaningful improvement of symptoms in all patients. There were no major intra-operative or post-operative complications. The investigators concluded that the NUBAC could be considered a viable surgical option for patients with LBP caused by early stages of DDD.
Companies, Products and Regulatory Status in the Nucleus Replacement Market
|Arthro Kinetics||Collagen matrix||In development|
|Biomet||Regain||CE Mark; Japan study underway; IDE underway|
|Cambridge Polymer||Injectable hydrogel||In development|
|DePuy Spine||SINUX ANR||CE Mark|
|Dynamic Spine||IPD||In development|
|Gentis||DiscCell||CE Mark filed|
|NuVasive||NeoDisc||FDA cleared; CE Mark|
|Pioneer Surgical||NuBac||CE Mark; IDE begun 2009|
|Replication Medical||NeuDisc||Pilot clinical studies|
|SpineWave||NuCore||Pilot clinical studies|
|TranS1||PNR||Pilot clinicals in Europe started 2008; on hold in US.|
|Vertebral Technologies||InterCushion||Feasibility trial outside US 2010|
|Zimmer||Newcleus||Pilot clinicals in Europe ongoing.|
Source: MedMarket Diligence, LLC; Report #M520.