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.

On-X is a high-grossing product for Artivion and generated $35.6m in sales in H1 2023, as per the company’s financials. The US-based company has a market cap of $590.973m.

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.

“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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.