The FDA's pre-market approval of Edwards Lifesciences' Sapien transcatheter device marks the first time such a device has been approved in the U.S. market, according to a Mass Device report.
The device, which allows coronary valve replacement without open-heart surgery, can now be purchased directly from the company. Sales between $20 million and $25 million are expected in the first three months, and sales between $150 million to $250 million are expected in the first year.
Related Articles on Medical Devices:
Medical Device Recalls Continue to Increase in Third Quarter
FDA Opens Comment Period for Medical Device Labeling
Report: Growth in Medical Device Adverse Events Outpaces Industry Growth
The device, which allows coronary valve replacement without open-heart surgery, can now be purchased directly from the company. Sales between $20 million and $25 million are expected in the first three months, and sales between $150 million to $250 million are expected in the first year.
Related Articles on Medical Devices:
Medical Device Recalls Continue to Increase in Third Quarter
FDA Opens Comment Period for Medical Device Labeling
Report: Growth in Medical Device Adverse Events Outpaces Industry Growth