The FDA initially expressed concern about the high cancer rates among clinical study patients receiving Amplify for posterlateral lumbar fusion, but the FDA’s Orthopaedic and Rehabilitation Devices panel voted 6-5, just narrowly recommending to the FDA that the device be approved in July 2010.
In a filing with the Securities and Exchange Commission, Medtronic said the FDA would not approve Amplify without additional information from the company but did not make mention of what data segments were requested, according to the news report.
Following the FDA’s decision, Medtronic shares plummeted 2.8 percent.
Read the news report about FDA’s rejection of Medtronic’s Amplify.
Read other coverage about Medtronic’s Amplify:
– FDA Panel Votes to Recommend Approval for Medtronic’s Amplify Spine Device
– Millennium Research Group: Bone Graft Substitute Market to Reach $2.3B by 2015
