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| Benefit assessment of an innovative medical device: A study commissioned by the Federal Joint Committee (G-BA)

Commissioned by the Federal Joint Committee (G-BA), IHF GmbH is running one of the first studies on benefit assessment of a medical device in accordance with the directive § 137e Social Security Code Book V (SGB V).

Target of the PASSPORT-HF study is the effect of supporting heart failure care with the CardioMEMSTM HF-System. The CardioMEMSTM HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients.

The CardioMEMSTM HF System is the first and only FDA-approved heart failure monitor proven to significantly reduce heart failure hospital admissions. The main advantage is based on the telemedical transmittance of patient data, with which medication and therapy can be timely adjusted. The PASSPORT-HF study will examine whether comparable positive effects can be expected in the statutory national health system.

On suggestion of the manufacturer Abbott GmbH & Co. KG, the Federal Joint Committee has commissioned a study on benefit assessment and assigned IHF GmbH as an independent institute to perform it. The directive in accordance with § 137e Social Security Code Book V (SGB V) introduced in 2011 is intended to assess the benefit of new treatment methods. Based on the results, the G-BA will decide whether the CardioMEMSTM HF system will be integrated into the statutory health insurance standard care and reimbursement systems.


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