What do you do when you've got this great idea for a device but have no funding to see it through the FDA regulatory process in a timely fashion?
Some might wait and raise the appropriate funding to get the device through the regulatory path, but if the inventor is anything like Sanford Clinic Neurosurgeon, Wilson Asfora, MD, then waiting to make the device isn't even a consideration. It's an after thought.
Asfora developed the Asfora Bullet Cage, a device used in posterior lumbar interbody fusion surgeries to treat degenerative disc disease. Earlier this month he received FDA clearance to market the device after 10 years of developing it. Toward the end of the regulatory process Asfora worked closely with Sanford Health (Sioux Falls, South Dakota) to market the device.
"When I went into neurosurgery it was for fun," Asfora told Medical Device Daily. "Money was never an option."
Indeed it wasn't, since Asfora went through the IDE process for his device without any sponsorship and in one sole center, his private practice.
"Doing an IDE by oneself is quite difficult and it takes a long time," he joked. "I was the only investigator and it took me 10 years to get enough patients. But the rate of fusion for the device is the highest rate of fusion of any cage technology. The idea of the cage isn't mine I simply improved upon it."
Fusion cage technology was originally designed more than a decade ago, and was used to help the spine heal between the vertebral bodies rather than along the back of the spine. A more stable fusion is said to be obtained once the disc between the vertebral bodies is removed and replaced with cages and bone graft.
Asfora decided to go with a cage that was shaped much like a bullet – because of the relative ease of implanting it in a patient. "The pointed end was what really made the device simple to implant in a patient," he said.
The device is set to launch in October and there are no current plans to seek marketing in Europe. Asfora's own company, Medical Designs (Sioux Falls) will be manufacturing the device.
"We congratulate Dr. Asfora on the FDA approval of his spinal implant," said Dave Link, Sanford Health Executive Vice President.
"At Sanford Health, our goal is to foster an environment which supports the efforts of our physicians to develop innovative solutions for the global healthcare market."
Asfora currently serves as a Neurosurgeon at Sanford Clinic in Sioux Falls, South Dakota. He specializes in adult and pediatric neurosurgery, spine surgery, brain tumor surgery, cerebrovascular surgery, peripheral nerve surgery, radiosurgery and functional neurosurgery including deep brain stimulation for movement disorders. Asfora is board certified with the American Board of Neurological Surgery and the Royal College of Physicians and Surgeons of Canada. Asfora has been with Sanford Health since 2007 and has worked as a Neurosurgeon since 1989.
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 (Minneapolis).
• 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, Asfora is currently leading a nationwide 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.
Omar Ford, 404-262-5546; firstname.lastname@example.org