The OPRATM Implant System clinical study on the below-knee amputation level recently received FDA approval, and recruitment to the study will start as soon as the protocol is approved by the Investigational Research Board (IRB). Once the study is finalized, Integrum will be able to use the data in any future regulatory process.
“We are fully committed to broadening the use of our innovative implant system to improve the lives of as many amputees as possible. We see it as a great recognition of our products’ potential that the US Department of Defense has decided to fully fund the study and that top surgeons at the Walter Reed Military Hospital will perform the surgical procedures. The results will be instrumental for a future Pre-Market Approval application for use in transtibial amputations, and we look forward to supplying OPRATM Implant Systems to the study,” says Rickard Brånemark, CEO of Integrum.
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