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Edwards' new heart implant gets FDA nod amid legal tussle with Boston Scientific

Edwards Lifesciences Corp.'s heart implant Sapien 3 Ultra system was approved by the U.S. Food and Drug Administration to treat a condition in patients who are at a high risk of open-heart surgery.

The product, an upgraded version of the Sapien valve, is meant to treat patients with aortic stenosis — a condition in which the heart's aortic valve narrows and does not open fully, causing a reduction or blockage in blood flow from the heart to the main artery.

The Irvine, Calif.-based medical device maker said the new system features enhancements on the valve and a new delivery system.

Marlborough, Mass.-based Boston Scientific Corp. says the heart implant infringes on its patents, winning a $35 million award earlier this month after a jury concluded that was the case in the U.S.

However, Edwards does not expect to pay the jury award since the U.S. Patent and Trademark Office invalidated the patent in question earlier this year. In the same ruling, the jury also noted Boston's Lotus heart implant did not infringe on an Edwards patent, which the company plans to appeal.

A court in Germany also made a ruling in favor of Boston Scientific earlier this year, prompting the company to block the sales of Edwards' valve in the country.