MEDICAL DEVICE INNOVATION - Medical Device Daily

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Bullet Cage IDE an example
of do-it-yourself perseverance
MEDICAL DEVICE INNOVATION 2010
By OMAR FORD
Medical Device Daily Staff Writer
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
to 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.
(This story originally appeared in the Sept. 1, 2009, edition
of Medical Device Daily)
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