The company expects the approval will add $200 million to annualized gross margin in the United States and Japan by the end of 2012.
The early approval might allow the company to record a pretax charge of $40 million during the fourth quarter of this year.
Related Articles on Medical Device Approvals:
FDA Clears Aptus Endosystems EndoStapling System
FDA Approves Carestream’s Vue Motion Medical Image Viewer
FDA Approval for Edwards’ Sapien Device is a First for U.S. Market
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
