RTTNews | Jan 31, 2021 07:57PM EST

19:57 Sunday, January 31, 2021 (RTTNews.com) - Edwards Lifesciences' (EW) bioprosthetic surgical aortic valve with its RESILIA tissue platform showed favorable safety and hemodynamic performance through a median of five years follow-up, as per new data from the COMMENCE clinical trial.

There were no incidences of structural valve deterioration (SVD) at the five-year review mark, a key safety outcome. SVD can be caused by a buildup of calcium on the valve's tissue or by other damage that impacts long-term durability of the valve.

RESILIA tissue is specially formulated using a proprietary integrity-preservation technology that may eliminate a key factor in calcification leading to valve deterioration.

The COMMENCE study is a single-arm investigational device exemption trial comprised of 689 patients at 27 clinical sites across the United States and Europe. The trial evaluated the safety and effectiveness of Edwards' RESILIA tissue aortic valve in patients ages 18 and older with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery.

Read the original article on RTTNews ( https://www.rttnews.com/3165174/edwards-resilia-tissue-aortic-valve-shows-favorable-safety-and-efficacy-at-five-years.aspx)

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