Medical Device Network

Daily Newsletter

06 October 2023

Daily Newsletter

Artivion strengthens On-X heart valve data with real-world study

Real-world data of Artivion’s On-X heart valve showed reduced mortality and bleeding events with a low dose of warfarin therapy.

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 37^thEuropean 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.

“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.

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.

Patient consumerism is gaining momentum

Healthcare is evolving from a ‘doctor knows best’ mentality to a patient-doctor relationship where the patient takes an active role in making informed healthcare decisions. Patients can have more of a say in their healthcare decisions because they have access to information through various means, including the literature, the internet, and more recently, different types of connected medical devices. With the rise of mobile health applications, wearable technologies, and telemedicine, patients are well-situated to gain medical information, and ultimately make the best choices for their health.