Artivion Announces Publication of On-X® Mitral Heart Valve PROACT Study Results in The Annals of Thoracic Surgery

Results presented at the 2022 Annual Meeting of the Society of Thoracic Surgeons

ATLANTE, January 31, 2022 /PRNewswire/ — Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company specializing in aortic disease, today announced the publication of results from the PROACT clinical trial in Annals of Thoracic Surgery, the official journal of the Society of Thoracic Surgeons. The publication, titled Low-dose warfarin versus standard warfarin after mechanical mitral valve replacement: a randomized controlled trial, https://www.annalsthoracicsurgery.org/article/S0003-4975(22)00138-2/fulltext, highlighted the results of the multicenter, two-arm non-inferiority study that assessed whether, after mechanical mitral valve replacement (MVR) On-X, patients could be safely managed with low-intensity warfarin plus aspirin. The results have been published online at January 29, 2022. Along with the publication, the results of the study were presented at the 2022 annual meeting of The Society of Thoracic Surgeons to January 30, 2022.

(PRNewsfoto/Artivion, Inc., CryoLife, Inc.)

“The PROACT Mitral results add to data from clinical trials we have sponsored, showing that patients with our On-X heart valves can be safely maintained with lower levels of anticoagulation than those required for heart valves. mechanisms of competitors. We continue to invest in scientific studies to improve and simplify the lives of patients with prosthetic heart valves. In addition, the ongoing PROACT Xa trial aims to prove that patients with aortic valve On-X can be safely maintained on apixaban, without the need for routine anticoagulation blood tests,” said Pat Mackinchairman, president and chief executive officer of Artivion, Inc.

Michel WA ChuMD, FRCSC, Chairman/Head of Cardiac Surgery at London Health Sciences Centre, Western University, London, Ontario, Canadaand lead author of the PROACT mitral clinical trial, said, “This randomized trial has very important and reassuring results for patients with irreparable mitral valve disease. Patients with an On-X mechanical mitral valve can be reassured that a lower target INR is safe, without any increased risk of blood clots or stroke, which may help alleviate some of the concerns of managing anticoagulation with a mechanical valve We believe this research represents one of the most significant advances in the clinical management of mechanical mitral valves over the past 2 decades and will potentially have important implications for practice change and guidelines We are proud to having presented it at the annual meeting of the Society of Thoracic Surgeons with a simultaneous publication in The Annals of Thoracic Surgery.”

About the On-X Mechanical Heart Valve PROACT Trial
The PROACT Mechanical Heart Valve On-X Clinical Trial was a two-arm, multicenter non-inferiority trial to determine whether patients who have undergone On-X mechanical mitral valve replacement (MVR) can be safely managed. safety with low-intensity warfarin plus aspirin. After mechanical mitral valve replacement with On-X followed by at least 3 months of standard anticoagulation, 401 patients in 44 North American centers were randomized to receive low-dose warfarin (target INR of 2.0 to 2.5) or standard-dose warfarin (target INR 2.5 to 3.5). All patients were prescribed aspirin 81 mg daily and encouraged to use the home INR test. Mean patient follow-up was 4.1 years with a maximum follow-up of 8 years. No differences in the rates of bleeding, valve thrombosis or thromboembolism were observed between the groups of patients treated with low dose warfarin compared to the standard dose. This study demonstrates that a lower target INR is safe and feasible for patients with an On-X mechanical valve in the mitral position. The US Food and Drug Administration (FDA) is currently reviewing the labeling change recommendation for the On-X Mechanical Mitral Valve based on this clinical trial.

About the On-X Mechanical Heart Valve
On-X Mechanical Heart Valves are made with the industry’s most advanced design and materials, including a length-to-diameter ratio similar to a native valve, flared inlet port, leaflet opening up to at 90 degrees, an actuated swivel and pure pyrolytic carbon. These key features result in laminar flow, low gradients, and reduced thrombogenicity, making it the most clinically beneficial lifetime heart valve replacement option available to patients today.

About Artivion
Headquarters in the suburbs Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ toughest challenges in treating patients with aortic disease. The four main product groups of this multinational include: aortic stents and endoprostheses, prosthetic heart valves, cryopreserved cardiac and vascular allografts and surgical sealants. Artivion markets and sells products in over 100 countries around the world. For more information about Artivion, visit our website, www.artivion.com

contacts:

Artivion

Gilmartin Group LLC

D. Ashley Lee

Brian Johnston / Lynn Lewis

Executive Vice President, Chief Financial Officer

Telephone: 631-807-1986

and chief operating officer

[email protected]

Phone: 770-419-3355

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SOURCEArtivion, Inc.

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