Prof. Kęstutis Ručinskas, Head of the Heart and Thoracic Surgery Centre at Vilnius University Hospital Santaros Klinikos in Lithuania, who led the clinical investigation, commented: “The successful implantation of the TRIFLO Heart Valve in all planned patients marks a significant milestone in aortic valve disease management. Seeing our patients recover fully and thrive post-surgery reinforces the valve’s potential to change the landscape of aortic valve treatment. We are eager to continue this journey and implant more patients with this innovative device.”

“The completion of the enrollment phase in our First-In-Human study marks a significant milestone. The initial outcomes are promising and underscore the potential of our heart valve to transform patient lives. We will continue to monitor these patients and look forward to the validation of the unique properties of the TRIFLO valve,” said Pomme Boissier, Clinical Affairs Manager at Novostia.

The first implanted patients have already started a decrease in anticoagulation treatment that should be followed by a discontinuation in September 2024. The ten patients will be followed up for 18 months to monitor performance and effectiveness of the TRIFLO Heart Valve without Anticoagulation therapy.

Commitment to Long-Term Patient Care

The long-term performance and effectiveness of the TRIFLO Heart Valve will be evaluated from a five- years follow-up of the ten patients. This extended follow-up period will provide valuable data to further validate the benefits and reliability of this cutting-edge technology.