Interspinous process decompression device also called as interspinous spacer are medical implants used for treatment of spinal stenosis. This devices are intended to reduce the spinal pain via positioning between the vertebrae through minimally invasive surgical procedures. Interspinous process decompression device are one of the types of dynamic stabilization devices used for non-fusion spinal surgery, designed to be permanently implanted between two interspinous processes in lower spine without attaching screws or hardware to the bone or ligaments.
High prevalence of degenerative spinal disorders due to increasing aging populations and its advantages such as motion preservation, less blood loss, reduce risk of infection, and its outpatient surgical facility makes interspinous process decompression more preferred as compared to conventional spinal surgeries such as laminectomy. The popular interspinous process decompression device available commercially include X-STOP, DIAM (Device for Intervertebral Assisted Motion), Coflex, and Wallis. The major drivers for growth of the interspinous process decompression device market include new product launches, increasing incidences of spinal disorders, and increasing pool of geriatric population.
Interspinous Process Decompression Devices Market – Drivers
Since recent past, minimally invasive surgical procedures have gained traction resulting in development of various interspinous process decompression device. The global interspinous process decompression device market is expected to be driven by the new product launches by the market players. For instance, in 2015, Vertiflex, Inc., innovator in minimally invasive intervention for spinal stenosis, received Premarket Approval Application (PMA) order from the U.S. Food and Drug Administration (FDA) for its product, Superion, indicated for moderate lumbar spinal stenosis. The Superion is least invasive motion preserving device in interspinous spacers’ category. In 2015, the implant was successfully implanted in 2,000 patients around the world as a part of study and is expected to be available in the US market during the forecast period.
Moreover, in 2014, Exatech launched Octane Elevate, a new lumbar spacer to restore disc height and addressing anatomical conditions. In 2012, Paradigm Spine’s Coflex (previously called Interspinous U) Interlaminar Technology implant was approved by the FDA through the premarket approval process for one- or two-level lumbar stenosis from L1 to L5 producing at least moderate impairment in skeletally mature patients. Moreover, according to Permera Blue cross, the US-based medical insurance company, NL-Prow (by Non-Linear Technologies), Aperius (by Medtronic plc.), and Falena (by Mikai) devices are in trials in Europe.
Increasing incidence of spinal injuries is also expected to boost growth of interspinous process decompression devices market. According to the National Center for Biotechnology Information (NCBI), in 2007, the global incidence of spinal cord injury was estimated to be 170,312 cases, which increased up to 250,000 to 500,000 cases in 2013. Moreover, reimbursement policies are expected to fuel growth of the interspinous process decompression device market. For instance, in 2016, the International Society for the Advancement of Spine Surgery (ISASS) published recommendations and coverage criteria for decompression with interlaminar stabilization. However, lack of national coverage determination handover the policy discretion to local Medicare carriers.
Interspinous Process Decompression Devices Market – Restraints
Interspinous process decompression device market is expected to be constrained by limited market players and stringent regulatory scenario for the implantable device. Moreover, high cost of spinal surgical procedures and requirement of professionally trained surgeons are expected to hinder the market growth.
Interspinous Process Decompression Devices Market - Regional Analysis
Based on geography, the interspinous process decompression devices market is segmented into North America, Latin America, Europe, Middle East, Asia Pacific, and Africa. The North American interspinous process decompression device market holds a dominant position attributed to increasing adoption rate for new technologies. Furthermore, Asia Pacific is expected to witness fast growth during forecast period, owing to increasing medical facilities and increasing geriatric pool. For instance, according to Economic and Social Commission for Asia and the Pacific, 2016, between 2015 and 2030, number of people aged 60 years or older are projected to increase in Asia by 66%.
Interspinous Process Decompression Devices Market – Competitor
Abbott Spine, Paradigm spine, Medtronic Plc. and Vertiflex, Inc. are the key players implementing novel inorganic strategies for gaining maximum market shares, in turn strengthening market position. For instance, in 2015, Vertiflex, Inc., introduced two significant reimbursement milestone to broaden their opportunity for Superion (interspinous spacer). The reimbursement includes transition of Category III code to Category I, erasing the longstanding uncertainty associated with coverage and payment involved in category III. Furthermore, Superion based minimally invasive procedure in Ambulatory Surgical Centers will afford Medicare beneficiaries increasing the access. Both reimbursement plans are expected to expand the market opportunity for Superion and in turn increase the company revenues.
Interspinous Process Decompression Devices Market - Taxonomy
By Product Type
By End User