On-X Life Technologies said it nailed down an expanded labeling claim from the FDA for its aortic mechanical heart valve.
The change relates to an international normalized ratio blood test, which measures the length of time needed for a patient’s blood to clot. Regulators expanded the label to allow the Texas company’s aortic heart valve to be managed, beginning 3 months after surgery, at an INR level of 1.5 to 2.0 – closer to the ratio of unmedicated patients.
On-X said it won the change following the results of the company’s Proact trial, published in 2014 in the Journal of Thoracic and Cardiovascular Surgery, which showed high-risk patients with the On-X aortic valve saw less bleeding and no jump in stroke rates when they reduced their regular blood-thinning medication dosage to an INR of 1.5 to 2.0, and also took low-dose aspirin.
On-X CEO Clyde Baker said in prepared remarks that the "newly-approved expanded labeling, which lowers the recommended INR rates for On-X aortic valves, reinforces how our technology represents a single-life-long clinical solution that frees patients of worries of potential reoperation due to tissue valve failure.”
On-X founder Jack Bokros added, also in a prepared statement, that the FDA expanded labeling represented validation of a 50-year retrospective study of mechanical heart valves from 2014 that showed On-X’s pyrolytic carbon valves produced the lowest documented rate of clots versus 8 other competing products.
The company is using the FDA decision to tout its product’s benefits over valve replacements made with animal tissue, which some patients choose in order to avoid having to deal with side effects from blood-thinning medications such as warfarin.
Baker noted that tissue valves tend to fail within 15 years and carry the risk of subsequent operations for replacement valves. These patients must also frequently take warfarin, he said.
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