EW - Edwards Lifesciences' Resilia Tissue Aortic Valve shows favorable safety and efficacy

Announcing new data from a prospective study, Edwards Lifesciences (EW) said its bioprosthetic surgical aortic valve with the Resilia tissue platform indicated favorable safety and hemodynamic performance through a median of five years follow-up.The trial involving 689 patients aged 18 and above at 27 clinical sites across the United States and Europe evaluated the safety and effectiveness of Resilia tissue aortic valve in patients with diagnosed aortic valve disease and scheduled to undergo aortic valve replacement surgery.The data as presented at the 57th annual meeting of the Society of Thoracic Surgeons showed that there were no incidences of structural valve deterioration ("SVD") at the five-year review mark, identified by the company as a key safety outcome.Following the CE Mark received in Europe in 2016, Edwards’ Inspiris Resilia aortic valve product was granted FDA approval nearly four years ago.

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Edwards Lifesciences’ Resilia Tissue Aortic Valve shows favorable safety and efficacy