Artivion presented data from the post-market study of the On-X aortic heart valve showing that the valve was safe and effective with low-dose warfarin.
The data was presented as an abstract at the 37th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna (Austria) from 4-7 October 2023.
Valve replacement is done in patients with severe valvular heart disease. As blood flows around these valves it causes high stress, activating platelets and coagulation. To reduce this risk of thrombosis on the valve and subsequent embolism, anticoagulants like warfarin, are prescribed post-implantation.
The post-market study (NCT02677974) analysis included follow-up data from 1-5 years, with a follow-up time of 3.4 years.
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“Heart valve replacement therapy presents several post-operative challenges for patients, especially the need for blood thinners and the related risk of bleeding and thrombotic events,” said the abstract presenter, Professor Aung Oo.
“These long-term data demonstrate the clinical benefits of a lower-dose post-operative warfarin regimen, further validating the use-case for On-X valves with low-dose warfarin.”
Results showed a 2.31% linearised occurrence rate (control rate – 5.39%) of thromboembolism, valve thrombosis, and major bleeding. There was a 73% reduction in all bleeding events, with an 85% reduction in major bleeding events.
A market model by GlobalData indicates that the transcatheter aortic valve replacement market is expected to be worth about $19bn by 2033.
GlobalData is the parent company of Clinical Trials Arena.
In May, Artivion gained pre-market application (PMA) approval for its PERCLOT absorbable haemostatic system (PerClot) by the US Food and Drug Administration (FDA). The device is intended to control bleeding during surgeries. The approval also triggered the $18.75m milestone payment from Baxter International, as per the PerClot product line acquisition agreement.