FDA Approves New Pericardial Aortic Valve

The US Food and Drug Administration (FDA) has approved a new pericardial aortic valve (Inspiris Resilia; Edwards Lifesciences; Irvine, CA) indicated for the replacement of native or prosthetic valves.¹

The Inspiris Resilia valve consists of “stented trileaflets” that are made from Resilia tissue, which is bovine pericardial tissue that has been treated with Edwards Integrity Preservation technology.

COMMENCE (Prospective, Nonrandomized, Multicenter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform; ClinicalTrials.gov identifier: NCT01757665) was an open-label, prospective, nonrandomized, multicenter study that examined 2-year data from 689 patients.² After valve implantation, there were no incidences of valve thrombosis, nonstructural dysfunction, or structural deterioration.

In addition, adverse event rates — including all-cause mortality (1.2% early and 2.2% late), valve-related mortality (0.4% early and 0.7% late), thromboembolism (2.2% early and 2.1% late), and bleeding (0.9% early and 2.6% late) — were low.

A postapproval study has been ordered to continue following patients up to 5 years for further evaluation of the safety and effectiveness of the valve.

The valve was already approved in Europe and will become available in the United States in early 2018.

References

1. US Food and Drug Administration. PMA P150048: FDA summary of safety and effectiveness data.  https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150048b.pdf. Published June 29, 2017. Accessed July 13, 2017.
2. Puskas JD, Bavaria JE, Svensson LG, et al; for the COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue [published online June 10, 2017]. Eur J Cardiothorac Surg. doi:10.1093/ejcts/ezx158