Dawn of a New Era

The OSSpine™ implant offers controlled compression of vertebral segments at the time of surgery to enhance fixation and graft retention. It also actively compresses the fusion construct compensating for any graft subsidence that may occur during healing.

Shape memory alloy allows for dynamic compression at the time of surgery.
Actively reduces adjacent vertebrae to compensate for subsidence.
OSSpine™ compression forces complement Wolff¹s Law.
When activated, 20% stronger than annealed 316L stainless steel.
Compression force is applied from the back to the end of the OSSpine™ legs, which provides uniform compression.
Minimally invasive insertion and removal techniques decrease O.R. time and minimize complications.
OSSforce™ Implant Controller allows the surgeon to control the rate and amount of implant compression force desired.
Minimal anterior hardware to reduce incidence of esophageal irritation.

Indications:

For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts or autografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization devices*. This device is not intended to be used alone for load bearing applications.

*Stabilization or immobilization devices as defined in 21 CFR 890.3490 for the neck include cervical splints or collars.

A Brief History of Spinal Nitinol Staples:

Nitinol staples for anterior fixation of the spine have been described in the literature for over fifteen years for fusion, nonfusion, interbody and intrabody applications. Silberstein's (1992) study on 59 animals demonstrated a high degree of biocompatibility as well as bioadhesiveness of nitinol. His concurrent study (1997) spanned 8 years (1989-1997) and consisted of 84 patients proved the satisfactory use of nitinol implants for patients with fractures of the vertebral bodies, degenerative disc disease and tumors of the vertebral bodies.

Ricart (1997) used nitinol staples for 50 anterior cervical fixation cases between 1992 and 1995, all with tri-cortical iliac graft. His conclusions included: minimal space occupied, easy fitting and no risk to the spinal cord in comparison with screw-plate systems; constraining of graft to prevent migration; shorter healing times; axial compression without crushing or kyphosis; and stability sufficient for the use of a simple soft collar post-operatively. Ricart's description of these staples formed the basis of the BME OSStaple™ design.

More recently, Nitinol staples were tested by Braun (2004) in a goat model for arresting iatrogenic scoliosis. Betz reported on the successful use of Nitinol staples for the treatment of idiopathic scoliosis on 21 patients in 2003 and 39 patients 2005.

BME's OSSpine™ staple builds on this successful history of use by adding OSSforce™ control of the rate, force and extent of implant shape change. These allow the surgeon activate the implant slowly so as to observe and avoid nerve root compression while imparting the optimal fixation force for the patient¹s bone quality.

Together, nitinol spinal staples and OSSforce™ control provide the surgeon a new option for spinal fixation.

References:

Silberstein B. “Subtotal and total vertebral body replacement and interbody fusion with porous Ti-Ni implants.” SMST-97: Proceedings
of the Second International Conference on Shape Memory and Superelastic Technologies. Asilomar Conference Center, Pacifi c
Grove, California, USA. 1997.

Ricart O. “The use of a shape memory staple in cervical spine anterior fusion.” SMST-97: Proceedings fo the Second International
Conference on Shape Memory and Superelastic Technologies. Asilomar Conference Center, Pacifi c Grove, California, USA.
1997.

Braun JT, Ogilvie JW, Akyuz E, et al. “Fusionless scoliosis correction using a shape memory alloy staple in the anterior thoracic spine
of the immature goat.” Spine 2004;29:1980–9.

Betz RR, Kim J, D’Andrea LP, Mulcahey MJ, Balsara RK, Clements DH. “An innovative technique of vertebral body stapling for the
treatment of patients with adolescent idiopathic scoliosis: a feasibility, safety, and utility study.” Spine 2003; 28(20): S255-S265.

Betz RR, D’Andrea LP, Mulcahey MJ, Chafetz RS. “Vertebral body stapling procedure for the treatment of scoliosis in the growing
child.” Clin.Orthop Relat Res. 2005;(434): 55-60.