Artivion On-X aortic heart valve
The On-X aortic heart valve. [Image from the Artivion website]

Artivion (NYSE:AORT) today announced positive outcomes from a post-market study of its On-X aortic heart valve.

The company shared five-year real-world safety and efficacy data demonstrating even better outcomes than predicted by a previous study. Other data highlighted positive aortic remodeling outcomes as well and zero distal anastomotic new entry (DANE) tears.

Artivion’s five-year study of 229 participants showed a significantly lower composite primary endpoint of thromboembolism, valve thrombosis and major bleeding (1.83%) compared to the pre-defined historic control rate of 5.39%. It included an 87% reduction in major bleeding and no increase in thromboembolism. The study compared subjects to a historic control group of standard-dose warfarin.

According to Artivion, its real-world interim results show safety and efficacy with low-dose warfarin.

“The long-term data continue to validate the safety of managing On-X aortic valve patients at a lower INR in the range of 1.5 to 2.0 and our confidence in our ability to gain further market share with On-X globally,” said Pat Mackin, chair, president, and CEO of Artivion.

More positive data from Artivion

Late breaking data from Artivion’s PERSEVERE U.S. investigational device exemption (IDE) trial showed that, at 30-days following implantation of the company’s AMDS hybrid prosthesis, patients experienced positive aortic remodeling after treatment. They also saw no occurrence of DANE tears.

Artivion’s AMDS eliminates DANE tears and prevents flow in the false lumen. its stented section further supports the true lumen in the arch, too, inducing positive aortic remodeling.

The data highlighted the success of the system give the frequency of complications and the need for reintervention in these procedures.

“We are excited to continue to see positive results from the PERSEVERE study as they reinforce the unrivaled clinical benefit and life-saving nature of AMDS. The significant reduction in MAEs paired with the prevention of DANE and positive remodeling outcomes offer a major benefit to these patients without adding any technical complexity to the lifesaving operation,” Mackin said. “We now look forward to quickly completing patient follow up and our PMA submission to the FDA for AMDS.”