FDA Approves Synthes Artificial Spine Disc -2-
Tuesday August 15th, 2006 / 22h35
The product from Synthes is expected to compete against Johnson & Johnson's (JNJ) Charite artificial disc, which was approved in 2004.
In its approval letter to Synthes, the FDA said patients receiving the disc should have tried at least six months of "conservative" treatment with other therapies.
As a condition of approval, the FDA said the company has agreed to continue studying the disc for long-term safety and effectiveness in a study that must involve at least 286 patients. The company will also be required to conduct a yearly analysis of major adverse events with the device along with the number of devices sold and implanted each year. All companies are required to routinely report problems with medical devices and drugs to the agency.
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