Infuse is less invasive than a “traditional” bone graft system.
It is a two part system consisting of a protein found in the body and
a natural carrier that is a sponge manufactured from a cow type 1 collagen.
Infuse acts as the scaffold in a surgical bone grafting procedure. It
is manufactured by Medtronic Inc.
Recently two independent reviews found that Infuse works no better than
a graft and can carry adverse effects such as a risk of cancer, male sterility
and infections. “There is a tremendous amount of uncertainty about
the benefit it provides and how safe it is.” Harlan Krumholz, Yale
Chris O’Connell, president of Medtronic’s Restorative Therapies
Group said, the risk of cancer is low and the risk from Infuse is inconclusive.
“This is a really important product and it’s one that deserves
a lot of attention from the standpoint of clinical research.”
Yale review analyzed findings from two separate research groups. They were
given detailed data from 17 spinal studies using Infuse on more than 2,000
patients. “We couldn’t find a clear advantage in terms of
benefits, and when you take into account there could be potential risks
that should be more carefully evaluated, it tips the scales toward not
using it.” said senior author Mark Helfand, an internal medicine
specialist at OHSU.
University of York reviews found Infuse fusion rates to be better after
two years, with pain early on and less pain later. It also found that
cancer may be more common with the use of Infuse.
Medtronic is accused of manipulating information about Infuse by helping
to write and edit medical journal articles attributed to outside physicians,
which, downplayed the risks of Infuse, according to a report by Senate
investigators. The Senate Finance Committee said that Medtronic did not
disclose its role in shaping 13 key studies of Infuse, which helped turn
the bone graft into an $800 million a year product.
Reuters News Services, “Medtronic paid about $210 million in royalties
and consulting fees to the author of company-sponsored studies between
November 1996 and December 2010.”
Medtronic disagrees with the findings in the report saying “Medtronic
vigorously disagrees with any suggestion that the company improperly influenced
or authored any of the peer-reviewed published manuscripts discussed in
the report, or that Medtronic intended to under-report adverse events.”
The company’s spinal treatments fell 1.1% to %52.92. However, the
shares have gained 39% in past months.
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