Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device

Wilson Asfora, MD

A spinal implant was developed by Sanford Clinic Neurosurgeon, Wilson Asfora, MD, Sanford Clinic Neurosurgery & Spine. He received United States Food and Drug Administration (FDA) 510(k) market clearance as a lumbar intervertebral body fusion device. On August 14, 2009, the FDA gave 510(k) clearance to the Asfora Bullet Cage, a product which is designed for use in posterior lumbar interbody fusion surgeries to treat degenerative disc disease.

The 510 (k) clearance of the Asfora Bullet Cage represents the culmination of a decade of clinical research. Clinical experience to date demonstrates up to a 98 percent rate of interbody fusion of one or two levels in hundreds of cases using simply locally harvested bone without unexpected complications and without the use of pedicle screws and Bone Morphogenic Protein.

Dr. Asfora has authored dozens of publications on issues related to neurosurgery. In addition, he has developed numerous medical devices in use at hospitals around the world including:

• The Subdural Evacuating Port System (“SEPS”) a minimally invasive life saving device used to treat subdural hematomas and promote brain expansion without entering the subdural space. SEPS is now marketed globally by Medtronic, Inc.
• The Dakota Knife, a surgical instrument for the transection of the Carpal Ligament in open, limited-open, or minimally invasive Carpal Tunnel surgery.
• The Odontoid Curved Drill Guide, a surgical tool for anterior screw fixation of odontoid fractures. The device is particularly useful in Barrel Chested patients.

Through a research affiliation with Sanford Health, Dr. Asfora is currently leading a nation wide team of engineers, clinicians and regulatory experts in the development of new medical technologies for use in the fields of pain therapy, vascular surgery and pediatric diagnostics.