August 9, 2018

Boston Scientific eyes reintroducing recalled, remade product

Boston Scientific will soon submit the final technical module to the U.S. Food and Drug Administration for a heart valve product.

In a filing Wednesday, the Marlborough company said the final information for its premarket approval application for the Lotus Edge aortic heart valve system will be submitted sometime next week.

The rollout for the product has been challenged with first a voluntary recall for the system in early 2017 and then an announced delay to commercialization of the revamped system in both Europe and the U.S. last November.

The system received the European CE Mark in 2016, but the company recalled the product in February 2017 to make design changes with the intent to reintroduce the product in Europe by early 2018.

Boston Scientific now expects the product to launch in both U.S. and European markets in 2019.

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