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The Storm Clears for Medtronic
Much ado about nothing? The whispers were gaining volume prior to this Tuesday (July 27) when an FDA advisory panel presented their decision. All the hubbub was about Medtronic's (MDT) Amplify Spine Device and whether there was an increased risk of cancer associated with the new, yet to be approved product.
Just in case you missed it, here was the issue:
The Amplify rhBMP-2 (recombinant bone morphogenetic protein-2) Matrix, is a device designed to stabilize the vertebrae of the lower back in degenerative disc disease. These BMPs are genetically engineered versions of a naturally occurring protein and can also be found in the InFuse bone graft, another Medtronic product.
Medtronic gave data to the FDA that showed 13 cancer cases in patients who were treated with Amplify. That's compared to four cancer cases for alternate spine procedures looked at five years after receiving their implant (an increased cancer level of .4%). It should be noted that the 13 cancer cases presented vary greatly, with no one condition standing out as occurring more so than others.
The FDA ordered the Orthopaedic and Rehabilitation Devices advisory panel to make a recommendation about the product. And that's where Tuesday's meeting comes in. Here's a breakdown of how the voting went down:
The Orthopedic and Rehabilitation Devices Panel of the FDA voted…6 to 5 (with 3 abstentions) that the benefits of Amplify outweigh the risks. (Notice that's a pretty small difference, so not exactly an overwhelming show of support)
In terms of safety: 9 for, 4 against with 1 abstention.
In terms of efficacy: 10 for, 3 against, with again 1 abstention/
Some of the concerns that the panel voiced were as follows:
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The aforementioned higher rate of cancer (although most on the panel didn't see a direct cause/effect, some did wonder about whether rhBMP-2 may speed up the growth of pre-existing cancers)
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Antibody formation
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Lack of studies of possible effects on fetuses
A few other stats and figures to report: The FDA presented information from some 400 patients that show a 60% overall success rate for the Amplify group of patients, which was better than the 55% rate for the control group. Both groups success rate fell after five years, with the Amplify group experiencing a rate of 44%. 10.5% of Amplify patients in this study suffered serious back or leg pain, a few percentage points more than the control group.
Stay tuned for an approval decision from the FDA by the end of the year.