In recent months, payers have become keener to sacroiliac joint fusion devices, and researchers are exploring the technology further.
Eight key SI joint developments in the past 12 months for surgeons to know:
1. Analysts with Calibre Reserach project the sacroiliac joint fusion market to grow 18.4 percent by 2019. The estimated market size in 2021 was $194.7 million.
2. SI-BONE's iFuse Bedrock Granite spine implant received a CMS new technology add-on payment, with a cap of up to $9,828 incremental payment per case, in addition to the hospital’s local DRG payment from Medicare. The iFuse Bedrock Granite implant is designed for sacroiliac fusion and sacropelvic fixation and received the FDA's breakthrough device designation.
3. A 12-month study confirmed the effectiveness of Surgalign Holdings' SImmetry system for sacroiliac joint fusion. The study examined clinical outcomes after minimally invasive sacroiliac joint fusion with decortication. Researchers looked at 250 participants across 23 sites. After 12 months, 72.2 percent of patients achieved the minimal clinically important difference criteria of reduction in the VAS pain measurement, and 62.5 percent of patients achieved the MCID criteria of reduction in the oswestry disability index.
4. A posterior approach to sacroiliac joint fusion led to improved pain scores over three to six months, a study found. Researchers examined outcomes in 69 patients who had a sacroiliac joint fusion with PainTEQ's LinQ implant. After six months, one patient had a serious adverse event. A competitor's lateral approach had a 15.1 percent SAE incidence.
5. The American Medical Association established a Category III CPT code for MIS sacroiliac joint fusion procedures using “intra-articular” implants placed within the SI joint, which do not “transfix” or cross the SI joint in a transiliac trajectory. The code was created for procedures effective January 1, 2023, according to the International Society for the Advancement of Spine Surgery. Beginning July 1, 2023, yet another Category III ("t-code") will be added, to describe insertion of both lateral transfixing and intra- articular (non-transfixing) implants in the same operative sessions ("hybrid").
6. AMA established a future Category 1 CPT code to describe intra-articular MIS sacroiliac joint fusion procedures which will not be effective until January 1, 2024. The new code will replace the Category III code previously added for 2023 procedures, and will describe such intra-articular technologies as PainTEQ's LinQ SI joint stabilization system.
7. Genesys Spine enrolled the first two patients in a study for the SIros system. The study will conducted across four locations in the U.S. The SIros system, which has 3D-printed implants, is designed to stabilize the sacroiliac joint and is used for lateral joint fusions.
8. Mark Stouffer, MD, completed the first case in Tenon Medical's clinical study for the Catamaran sacroiliac joint fusion system. Tenon Medical's study spans across multiple sites, and patients will be followed for two years to mark outcomes, radiographic assessments and adverse events.The Catamaran SI joint system is designed to offer a less invasive approach and has a single, titanium implant design.