On-X Life Technologies, Inc. Reports CE Mark Approval To Sell Its Mechanical Aortic Heart Valve With An Expanded Labeling Claim: A Reduction In The Required Use Of Blood Thinners

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AUSTIN, Texas--(BUSINESS WIRE)--On-X® Life Technologies Inc. announced today that its previously CE (Conformité Européenne)-marked On-X® Prosthetic Heart Valve has received European regulatory approval for an expanded labeling claim, which now permits the company to market its breakthrough mechanical heart valve in Europe with a reduced requirement for the use of blood-thinning drugs such as warfarin. The newly branded On-X® Plus 1.5™ Aortic Heart Valve is now the only heart valve that allows patients to be managed at INR (International Normalized Ratio) levels as low as 1.5, a near-normal level. An INR blood test measures the time it takes for patients’ blood to clot.

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