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22.01
2024

Novostia Celebrates Successful Implantations of TRIFLO Heart Valve in First Human Patient

Novostia, a pioneering medical technology company, proudly announces a significant milestone in its mission to revolutionize cardiovascular care. In the frame of its First-In-Human Clinical study PILATUS (ClinicalTrials ID: NCT06119607), the company has successfully implanted in December 2023 its groundbreaking TRIFLO Heart Valve in a human patient for the first time, marking a momentous achievement in the field of valve replacement. This FIH was performed in the context of a prospective, single-arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve.

Motivated by better Patient care and well-being through breakthrough innovation. 

Novostia’s TRIFLO Heart Valve represents a cutting-edge advancement in cardiac technology, designed to revolutionize aortic heart valve replacement, offering unprecedented improvements in blood flow dynamics and product longevity. Significantly, it paves the way towards eliminating the need for lifelong anticoagulation therapy, a paradigmatic shift in the treatment of heart valve diseases. This breakthrough not only minimizes the risks associated with prolonged anticoagulation but also addresses patient concerns like noise-induced discomfort, enhancing their quality of life. This milestone is a testament to Novostia’s commitment to innovation and its unwavering dedication to improving patient outcomes in the cardiovascular space.

Seeing our patients recover fully and thrive post-surgery reinforces the valve’s potential to change the landscape of aortic valve treatment.

Prof. Kęstutis Ručinskas, Head of Heart and Thoracic Surgery Centre of Vilnius University Hospital Santaros Klinikos, Lithuania 

Prof. Kęstutis Ručinskas, Head of Heart and Thoracic Surgery Centre of Vilnius University Hospital Santaros Klinikos, Lithuania, who led the clinical investigation and implantation procedure, expressed enthusiasm about the success and commented: “The successful implantation of the TRIFLO Heart Valve is a significant step forward 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.”

Global Impact on Cardiovascular Health 

Novostia’s TRIFLO Heart Valve is poised to bring about a quiet revolution in the treatment of aortic heart valve replacement. The company anticipates that patients around the world will soon benefit from this disruptive technology, offering a new level of hope and improved quality of life for those with aortic stenosis and/or regurgitation.

 

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