“You know exactly what you want, based on the anatomy of the patient,” says the Brazilian-born neurosurgeon-inventor, a member of Sanford Clinic Neurosurgery & Spine in Sioux Falls, S.D., part of 23-hospital Sanford Health.
Dr. Asfora recently won FDA 510(k) market clearance for his Bullet Cage, a lumbar intervertebral body fusion device to treat degenerative disc disease. It took him 10 years to complete the FDA approval process because he used his own patients for the required clinical studies. “These studies can be very expensive if they go on at other sites, and I did not have the money for that,” he says.
Dr. Asfora says the concept behind the Bullet Cage has existed since 1941, when a Hawaiian surgeon developed an approach to treat sailors injured in the attacks on Pearl Harbor. The surgeon replaced spinal discs in patients with bone but it caused nerve damage. Following several iterations since then, Dr. Asfora’s version incorporates improvements such as being minimally invasive and using a posterior surgical approach instead of going in through the belly.
Dr. Asfora already has generated a small list of patented FDA-approved inventions, including a kit, called SEPS, to drain subdural hematomas. He sold SEPS to Medtronic. “Medtronic made back in the first year what they paid me for SEPS,” he says.
He plans to distribute the Bullet Cage through his own company, Medical Designs, which outsources testing, manufacturing and packaging to other firms.
“All of the things I have invented I needed in my personal practice,” he says. “Marketing them was not the main purpose.”
There are similar devices to the Bullet Cage already on the market, but Dr. Asfora prefers his own version, citing its high fusion rate. He says colleagues in the upper Midwest have indicated they want to use the device. “The local boys, they like it,” he says.
Learn more about Medical Designs at www.medicaldesignsllc.com.
