FDA Approves CryoLife’s Trial for Heart Valve

The FDA has given CryoLife the go-ahead to begin a clinical trial of its On-X mechanical aortic valve to determine if patients may use a different blood thinner with the device.

The study is being conducted to see if patients implanted with the prosthetic heart valve can safely take Pfizer’s novel oral blood thinner Eliquis (apixaban) instead of warfarin.

The company’s heart valve is the only mechanical valve that is FDA approved and CE Marked for use with a reduced level of warfarin.