The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.
The panel found that patients were aware whether they were included in the tests’ control group and identified shortcomings in the safety and effectiveness of the product.
No adverse effects commonly ascribed to bone growth products were detected during the study, but the putty was not proven to be effective, according to the panel.
