Artivion has presented new clinical data from two trials, one demonstrating better patient outcomes when using its On-X aortic valve, and another validating the safety of its AMDS hybrid prosthesis device to treat DeBakey Type I aortic dissections.
The data was presented at the 104th American Association for Thoracic Surgery (AATS) Annual Meeting in Toronto, Canada.
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A post-market study (NCT02677974) tracking 229 participants over five years demonstrated that the On-X aortic valve, combined with a low dose of warfarin therapy, resulted in significantly fewer complications like blood clots, valve issues and severe bleeding. This improvement was evident compared to previous studies where standard warfarin doses were used. Participants experienced an 87% reduction in major bleeding incidents without an increase in blood clotting problems.
On-X is one of Artivion’s highest-grossing products, generating $74.5m for the US-based company in 2023, as per the company’s financials.
Artivion CEO James Patrick Mackin said: “The long-term data continue to validate the safety of managing On-X aortic valve patients at a lower INR [international normalised ratio] in the range of 1.5 to 2.0 and our confidence in our ability to gain further market share with On-X globally.”
INR is a measure used to monitor and standardise the effectiveness of anticoagulant medications like warfarin.
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By GlobalDataAccording to a GlobalData analysis, the transcatheter aortic valve replacement market in the US is forecast to generate $4.7bn in 2030.
Additionally, late-breaking data from the AMDS PERSEVERE trial (NCT05174767) determined that patients with acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis device. Debakey Type I refers to a tear in the ascending part of the aorta, a severe and potentially life-threatening condition.
At 30 days, AMDS led to positive aortic remodelling in over 80% of patients across the aortic arch demonstrated by three main measurements – total aortic diameter stabilisation, true lumen diameter increase, and false lumen thrombosis. The device also eliminated distal anastomotic new entry (DANE) tears, a challenging type of aortic dissection to manage.
The 93-participant trial will support Artivion’s premarket approval application to the US Food and Drug Administration for the AMDS device, as per the 29 April announcement.
