The Stryker SpineJack system is thought to be superior to the most common treatment option for an osteoporotic vertebral compression fracture
The Centers for Medicare & Medicaid Services (CMS) has announced the Stryker SpineJack implantable fracture reduction system qualifies for the Transitional Pass-Through (TPT) payment as part of the 2021 Medicare Hospital Outpatient Prospective Payment System.
This announcement comes just over two months after CMS awarded the SpineJack System the New Technology Add-on Payment (NTAP), which provides additional payment in the hospital inpatient setting.
The titanium implantable vertebral augmentation device branded SpinJack protects against adjacent level fractures in those who have suffered an osteoporotic vertebral compression fracture (VCF) by decreasing the load that is typically distributed to the adjacent vertebral bodies.
Greg Siller, vice president and general manager of Stryker’s interventional spine business said: “The CMS Transitional Pass-Through payment determination is a monumental step in providing a superior device technology in the treatment of osteoporotic vertebral compression fractures.
“Due to the SpineJack System receiving both NTAP and TPT payment, physicians and administrators no longer have to make a decision between care and cost.
“We remain committed to offering innovative interventional spine solutions and working with our customers to improve patients’ lives.”
The TPT payment will be effective on January 1 2021 and will provide outpatient facilities with incremental Medicare payments for the SpineJack System for up to three years.
The SpineJack System now becomes one of only 11 medical devices to receive TPT status since 2016.
Clinical evidence for Stryker SpineJack system
The TPT decision was based on both public commentary as well as findings from a 12-month clinical trial published in The Spine Journal in November 2019.
The SAKOS trial was a prospective, multicenter, randomised study designed to support a non-inferiority finding for use of the SpineJack System versus the commonly-used Balloon kyphoplasty (BKP) in the treatment of painful osteoporotic VCFs.
SAKOS provided compelling evidence to establish the superiority of the SpineJack System over BKP with regards to absence of adjacent level fractures and midline vertebral body height restoration at both 6 and 12 months after the procedure.
Out of the 126 patients who underwent surgery and completed follow-ups at one, six and 12 months, pain relief was significantly more marked in the SpineJack group compared to the BKP group at 1 month and 6 months after surgery.
On top of this, the incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP, with the study recording 12.9% versus 27.3% incidence rates respectively.