Nucleus Arthroplasty and Nucleus Disc Prostheses in Spine Surgery

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

CompanyProductRegulatory status
Arthro KineticsCollagen matrixIn development
BiometRegainCE Mark; Japan study underway; IDE underway
Cambridge PolymerInjectable hydrogelIn development
ClarianceNucleoFilIn development
CryoLifeBioDiscCE Mark
DePuy SpineSINUX ANRCE Mark
Dynamic SpineIPDIn development
GentisDiscCellCE Mark filed
NuVasiveNeoDiscFDA cleared; CE Mark
Pioneer SurgicalNuBacCE Mark; IDE begun 2009
Replication MedicalNeuDiscPilot clinical studies
SpineWaveNuCorePilot clinical studies
StrykerAquarelleIn development
SynthesHydrafilIn preclinicals
TranS1PNRPilot clinicals in Europe started 2008; on hold in US.
Vertebral TechnologiesInterCushionFeasibility trial outside US 2010
ZimmerNewcleusPilot clinicals in Europe ongoing.

Source: MedMarket Diligence, LLC; Report #M520.