Medtronic has reported that its Mosaic bioprosthetic heart valve demonstrated positive performance results at 12 years in a study.
The US Food and Drug Administration (FDA) approved Mosaic bioprosthetic heart valve, which was approved by in 2000, is an artificial heart valve used to replace a patient’s diseased or damaged natural heart valve, usually the aortic or mitral valve.
The Medtronic Mosaic porcine bioprosthesis was evaluated in 1,029 patients who received aortic valve replacement (AVR) and mitral valve replacement (MVR) between 1994 and 2000.
The 12-year follow-up results of the study revealed a freedom from structural valve deterioration in 93.3% of AVR patients 60 years and older and in 95.3%of MVR patients 70 years and older.
Additionally, hemodynamic performance data showed stability up to 10 years, indicating durability of the Mosaic bioprosthesis over time.