Vivan has severe mitral regurgitation ^[1] and is preparing for mitral valve replacement surgery ^[2]. She is currently considering several different valve types (tissue, homograft, mechanical) and valve brands (Edwards, Medtronic and St. Jude Medical).

Vivian’s question to me is, “Adam – Can you tell me about the On-X valve for mitral valve replacement?”

For those of you who are not familiar with the On-X heart valve device for mitral replacement, here is some basic information for you:

• On-X was founded in 1994 and is located in Austin, Texas. It also owns Medical Carbon Research Institute in Hanover, Germany.

• According to the On-X valve website ^[3], the primary focus of On-X is (i) Continually improve pyrolytic carbon coating technology along with supporting processing and inspection technologies, (ii) Advance the level of prosthetic heart valve performance while reducing the level of patient valve-related complications, and (iii) Provide additional cardiac surgery products that uniquely improve patient care.

As for its valve offerings, the On-X® Prosthetic Heart Valve for mitral replacement is a pure carbon bileaflet heart valve prosthesis. One of the most interesting attractions of the On-X valve is that in January of 2006, the FDA approved the first-and-only IDE (Investigational Device Exemption) lowered anticoagulation trial for a mechanical valve to be conducted at 40 sites in the United States for the On-X® Prosthetic Heart Valve.

The patient groups in the PROACT (Prospective Randomized On-X Clinical Trial) study include a non-warfarin group of low-risk aortic valve replacement patients ^[4] and two low-dose warfarin groups of higher risk aortic and mitral valve replacement patients.

In case you missed that did not make sense… The significance of the On-X trial is that patients may obtain the benefits of a mechanical valve (duration, lower reoperation) without the risks of clotting problems due to lower Coumadin (Warfarin) dosages ^[5]. I have also heard that some patients are taking Plavix / aspirin instead of Coumadin in an ongoing On-X trial.

According to the company, over 50,000 On-X valves have been implanted since 1996.

I hope this give you some background on the On-X valve for mitral replacement. Over the years, I have spoken with many patients that are happy with their selection of the On-X valve. If you have an On-X replacement valve, please Leave A Comment ^[6] below and let us know your thoughts!

Keep on tickin!