FDA approves Medtronic
bone-growth product
Terry Fiedler
Star Tribune
Published Jul 3, 2002
Medtronic Inc. on Tuesday became the first company to get full Food and Drug Administration
approval to market a genetically engineered bone-growth product.
The protein, InFuse, is used with thimble-like metal cages for spinal fusion surgery and offers an
alternative to shaving bone chips from near the hip to promote bone growth.
Fridley-based Medtronic is licensing the protein from New Jersey-based Wyeth. Medtronic is the
leading maker of spinal-surgery products.
"This is the first major breakthrough of a biotech and device combination in the body," said U.S.
Bancorp Piper Jaffray analyst Thomas Gunderson.
Gunderson said InFuse could generate $50 million to $75 million in revenue for Medtronic for the
year ending in April 2003 and $120 million to $150 million the following year. He said the overall
market for such products eventually could be $1 billion a year.
A.G. Edwards analyst Jan David Wald called the approval significant for Medtronic and important
for spinal patients, who now have a less-invasive option for surgery.
Human bone morpho genetic protein, the active part of InFuse that induces the body to grow bone,
has been studied for more than 30 years.
"This product has the potential to redefine the way spinal surgery is performed," said Dr. Scott
Boden, an orthopedic surgeon at the Emory University School of Medicine in Atlanta.
The InFuse approval will add to Medtronic's $1 billion spinal and ear, nose and throat business,
which grew 24 percent in the past fiscal year.
About 190,000 lumbar spinal fusion surgeries are performed annually nationwide to ease
debilitating back pain. InFuse and the cages are approved to treat certain kinds of degenerative disc
disease, a common cause of such pain.
According to Medtronic, about 85 percent of the population will have some disc degeneration by
age 50.
Spinal fusion used to address the malady is essentially a welding process, in which a damaged disc
is removed and vertebrae are fused together with bone grafts and implanted devices, such as the
metal cages, into a single bone. The surgery eliminates the movement between the vertebrae
segments that causes the pain.
In conventional surgeries, bone chips are shaved from the hip bone in a separate surgery and placed
into the space between the vertebrae to be fused. Eventually the chips grow to fill the space.
Medtronic's InFuse is a collagen sponge infused with the genetically engineered protein and placed
inside two metal cages implanted between the vertebrae.
Clinical data have shown that InFuse fusion rates were basically as good as bone grafts. Because a
second surgery isn't required, the procedures are less expensive and patients lose less blood and
have less pain. InFuse costs up to $5,000, while the cages cost up to $3,000.
Studies have shown that spinal-fusion patients experience more pain from the hip surgery than
from the actual fusion procedure.
-- Terry Fiedler is at tfiedler@startribune.com . |
