FDA Approval for Edwards’ Sapien Device is a First for U.S. Market

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.

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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.

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