UK's National Institute for Health and Care Excellence (NICE) has published interventional procedure guidance recommendation for minimally invasive surgical (MIS) sacroiliac (SI) joint fusion, based primarily on clinical evidence from US-based medical device firm SI-BONE's iFuse implant system (iFuse).
The guidance document suggests that MIS SI joint fusion will be available to properly diagnosed chronic sacroiliac pain patients in the UK National Health System (NHS).
The minimally invasive iFuse utilises patented triangular titanium implants for generating an interference fit within the ilium and sacrum, to combine the SI joint.
The triangular shape of the implant and the press fit insertion aid immediate fixation by decreasing rotational motion.
The implants also allow long-term fusion of the joint by providing a suitable environment for ongrowth and ingrowth of the bone.
SI-BONE chief medical officer and medical affairs vice-president Carlton Reckling said: "Use with standard arrangements is the most positive recommendation that NICE can make for an interventional procedure such as MIS SI joint fusion.
"Standard arrangements means that there is enough high-quality clinical evidence to show that the procedure is effective and safe enough for doctors to consider as a treatment option for appropriate patients."
The published NICE recommendation states that MIS SI joint fusion is safe and effective under standard arrangements.
It adds that trained surgeons can perform the procedure on properly diagnosed patients with SI joint disfunction, caused by degenerative sacroiliitis or disruption of SI joint, through a lateral transarticular approach.
The clinical evidence of iFuse implant's safety, efficacy and economic benefits is based on three multi-centre clinical trials.