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Neoolife Transcatheter Tricuspid Valve Replacement (TTVR) system is the first device worldwide having an innovative, non-animal derived tissue-engineered Biomimetic Heart Valve with extended durability and resistance to thrombosis and calcification. Neoolife TTVR system additionally offers unique features such as ease of use, ease of delivery, cardiac conduction system management, and anatomical positioning.
Tricuspid Regurgitation (TR) has a high prevalence in the general population (> 15%), and it has a clear impact on patients’ functional status, quality of life, and survival.
Most of the patients with TR are treated medically because surgery has a greater than 10% mortality. Both medical and surgical treatments have failed to improve the outcomes of patients with TR. Therefore, TR and TR related complications result in substantial healthcare spending due to frequent re-hospitalizations. There is an unmet need for minimally invasive solutions to treat patients with TR. Transcatheter-based technologies will allow treating patients less invasively, at a much earlier stage of the disease, leading to optimizing outcomes. In this context, the market for percutaneous treatment of tricuspid exceeds that of mitral regurgitation.
Percutaneous repair and replacement technologies have been translated from the mitral to the tricuspid regurgitation field. Experience with percutaneous tricuspid repair remains limited, and results are dependent upon operator skills, disease stage, and anatomical features of the tricuspid valve and right ventricle. For this reason, TTVR has been foreseen as the best approach to treat patients with TR. Even if technically feasible, TTVR using valves made with the currently available animal-derived material will result in an unacceptable rate of prosthesis thrombosis. In fact, it has been already proven in the surgical arena that due to hemodynamic, hemostatic, and surface factors, animal-derived bioprostheses in the heart’s right side have a 20 times higher thrombosis rate than bioprostheses in the heart’s left side. There is enough scientific evidence supporting the fact that TTVR bioprostheses made with the currently available animal-derived material will not be successful in acceptable durability.
Neoolife TTVR system responds to the unmet clinical needs of the many patients affected with TR.
Caution: Neoolife products are in the R&D development and pre-clinical phase. They are NOT approved or cleared by the FDA or any other regulatory body in any region of the world.