Artivion gains FDA approval for PerClot, starts transfer to Baxter

PerClot requires no premixing, which means it can be applied to a bleeding source during surgery within second. [Image courtesy of Baxter]Artivion today announced FDA premarket application (PMA) approval of its PerClot absorbable hemostatic system designed to control bleeding in specific surgical procedures.

The Atlanta-based company will transfer full ownership to Baxter (NYSE: BAX) + , following a sale agreement that occurred in July 2021.

Artivion anticipates receiving an $18.75 million milestone payment under the terms of the agreement. Of this, $4.5 million will go to Artivion’s former partner, Starch Medical.

As part of the terms of the agreement, Artivion will supply Baxter with PerClot for a minimum of 21 months. This term will last until all manufacturing operations are successfully transferred to Baxter or its selected designee.

It’s an important milestone for Artivion

In a news release,…

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Artivion stops mechanical aortic valve clinical trial on the advice of Data and Safety Monitorting Board

Artivion (NYSE:AORT) this week stopped the Proact Xa clinical trial that was designed to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban.

The decision to stop the trial was based on the recommendation of the independent Data and Safety Monitoring Board (DSMB). The recommendation cited a lack of evidence supporting non-inferiority of apixaban to warfarin for valve thrombosis and thromboembolism.

Proact Xa was a prospective clinical trial. Patients having an On-X aortic valve replacement randomly received either warfarin or apixaban as their anticoagulant to prevent blood clots. It began enrollment in April 2020.

“The PROACT Xa trial was designed to determine whether apixaban would yield equivalent safety to the standard anticoagulant, warfarin. Unfortunately, it appears that it does not. On behalf of all of the investigators, we appreciate the research effort into the science of managin…

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Artivion announces positive trial results for its On-X mitral valve replacement

Artivion (NYSE:AORT) today announced positive results from a clinical trial for its On-X mechanical mitral valve replacement (MVR).

Atlanta-based Artivion (formerly CryoLife) published results in The Annals of Thoracic Surgery. The Proact clinical trial, a multicenter, non-inferiority, two-arm study assessed whether, after an On-X MVR, patients could be safely managed with lower-intensity warfarin plus aspirin.

The trial observed patients after their On-X mechanical MVR followed by at least three months of standard anticoagulation. In total, 401 patients across 44 North American centers were randomized to low-dose warfarin (target INR of 2.0 to 2.5) or standard-dose warfarin (target INR of 2.5 to 3.5). All patients were prescribed aspirin (81 mg daily) and encouraged to use home INR testing. Mean patient follow-up was 4.1 years with a maximum follow-up of eight years.

Artivion observed no differences in bleeding, valve thrombosis or thromboembolism rates…

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CryoLife announces corporate rebrand, changes name to Artivion

CryoLife today announced that it is rebranding itself and changing its name to Artivion, effective immediately.

The Kennesaw, Georgia-based company’s new name, derived from the words ‘aorta,’ ‘innovation’ and ‘vision,’ reflects its focus on creating devices to treat aortic disease. The company will also change its ticker symbol on the New York Stock Exchange to ‘AORT’ on January 24.

“Through a combination of legacy products and strategic acquisitions and divestitures over the last five years, we have transformed from a tissue and adhesives focused company to one with a premier portfolio of aortic products,” CEO and president Pat Mackin said in a news release. “Today marks an important milestone for our company. We look forward to embarking on our next chapter as a leader in developing simple, elegant solutions to address cardiac and vascular surgeons’ most difficult clinical challenge…

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