WASHINGTON (AP) — Federal health officials have approved a first-of-a-kind artificial heart valve that can be implanted without major surgery, offering a new treatment option for patients who are too old or frail for the procedure currently used.

The Food and Drug Administration said late Wednesday it approved the Sapien heart valve made by Edwards Lifesciences, which can be threaded into place through a major artery that runs from the leg up to the heart. Cardiologists say the highly anticipated new approach will help patients who cannot undergo the more invasive open-heart surgery, which has been used to replace valves for decades.

Other companies have won approval for less-invasive heart valves before, but Edwards’s implant is the first replacement for the aortic valve, the heart’s main doorway.

About 300,000 American patients suffer from deterioration of the valve, which forces the heart to work harder to pump blood, often leading to heart failure, blood clots and sudden death. More than half of patients with the condition, called aortic stenosis, die within two years, according to the F.D.A.

Every year about 50,000 people in the country undergo open-heart surgery to replace the valve, which involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one into place. Thousands of other patients are turned away, deemed too old or ill to survive the operation.

Dr. David Holmes of the Mayo Clinic said the Sapien valve is a “game changer” for those inoperable patients, many of whom are in their 80s with medical conditions like diabetes, emphysema and liver disease.

The device is approved only for patients who cannot have open-heart surgery. The valve has already been approved for four years in 40 countries, including most of Europe.

Edwards is expected to charge about $30,000 for the valve, though hospital fees could bring the total cost of surgery closer to $70,000. Standard heart valve replacement costs more than $50,000, mostly from surgical and hospitalization fees.

Edwards Lifesciences had sales of $1.5 billion last year. Analysts estimate that sales of the valve could help double the company’s revenue in a decade.