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Mini-HTA for Tendyne Mitral Valve System released in Norway
Norway established in 2013 a framework for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. This framework is called the “New Method.”
In this framework, all innovations should undergo HTA before being funded. If the method concerns only one or two hospitals, the assessment shall be initiated by clinicians and ran at the hospital level. The final report is disseminated via a mini-HTA database. If the method is of national concern, it undergoes Single Technology Appraisal at the national level, followed by the funding decision by the group of payers (Decision Forum, Beslutningsforum).
At the end of February 2020, a completed mini-method assessment for the Tendyne Mitral Valve System was released. The Tendyne is a bioprosthesis designed for transapical implantation within the native mitral valve without the need for open-heart surgery and concomitant surgical removal of the failed native valve. The following conclusions were provided:
- The good level of efficacy was shown by the studied method in comparison with the current treatment of mitral regurgitation that includes medical management, surgical repair or replacement of the mitral valve, transcatheter mitral valve repair (TMVr)
- The method was determined as safe in comparison with the current treatment of mitral regurgitation
- The method should be introduced as part of the clinical routine in the hospital
- It is specifically outlined that the patients should be followed up like surgical replacement patients
See the full details in Norwegian here.
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