FDA approves valve treated to prevent calcification

The FDA approved a bioprosthetic heart valve that is treated to improve durability.

The Italian company Sorin Group announced that it received FDA approval for its Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment. The treatment extracts phospholipids from pericardial tissue. Phospholipids have been linked to the calcification process of bioprotheses, which affects durability. In animal models, the treatment process reduced calcium uptake compared with a control.

Mitroflow with Phospholipid Reduction Treatment received CE mark on July 28, 2011.