Medtronic gets key FDA nod for bone-graft product
Terry Fiedler
Star Tribune
Published Jan 11 2002
Medtronic Inc. is closer to U.S. marketing of a genetically
engineered bone-graft product, an alternative to shaving bone
chips from near the hip for use in spinal-fusion surgery.
A panel of outside experts voted unanimously Thursday to
recommend that the Food and Drug Administration approve
Medtronic's product, called InFuse, for U.S. sales.
The panel also recommended post-approval studies of InFuse
in the areas of antibody response during pregnancy and effect
on pre-existing tumors. A positive recommendation by the
expert panel normally is followed by FDA approval.
Prudential Financial analyst Sandra Hollenhorst called InFuse
"an important new growth opportunity" for Fridley-based
Medtronic that could generate $500 million in annual sales,
perhaps as soon as in 2004.
U.S. Bancorp Piper Jaffray analyst Thomas Gunderson said
InFuse would be the first bone-growth factor product to get full
FDA approval and be widely used.
Michael DeMane, president of Medtronic's spine business, said
it's likely that the product could be on the U.S. market by July.
He noted the panel's decision was a landmark because bone
morphogenetic protein, the active part of InFuse that induces
the body to grow bone, has been studied for more than 30 years.
"This is the most-anticipated technology in the history of spine
surgery," DeMane said.
The InFuse approval should help continue the growth of
Medtronic's spinal surgery business, which is growing 25
percent a year.
Medtronic as a whole is expected to have earnings-per-share
growth of 17 percent in the fiscal year starting in April, spurred
by new product introductions, such as InFuse. The company is
expected to generate $6.4 billion in revenue in the current
fiscal year.
About 250,000 spinal fusion surgeries are performed annually,
150,000 of them in the lumbar (lower back) region, where
InFuse first might be used.
The panel's recommendation also stipulates that InFuse be
used with spinal cages and for treatment of patients with
certain types of degenerative disc disease, a common cause of
low-back pain. Degeneration of discs -- the shock absorbers
between vertebrae -- is normal with age, but in some people it
causes debilitating pain when the discs or the growth of bone
spurs pinch and put pressure on nearby nerve roots or the spinal
cord.
Spinal fusion essentially is a welding process, in which two or
more 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 product -- a collagen sponge infused with
a genetically engineered bone morphogenetic protein -- offers
an alternative to the bone harvesting. InFuse is used inside two
Medtronic metal cages implanted between the vertebrae.
The protein is licensed by Medtronic from American Home
Products.
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. Numerous studies have shown that
patients experience more pain from harvesting than they do
from the actual fusion procedure.
-- Terry Fiedler is at tfiedler@startribune.com .
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