Publication of CardioMEMS HF System long-term effectiveness in reducing heart failure hospitalisations published in The Lancet- St Jude Medical

St Jude Medical announced the publication of new, prospective data further supporting the long-term effectiveness of the CardioMEMS HF System at reducing heart failure (HF) hospitalisations for patients with New York Heart Association (NYHA) Class III HF in The Lancet journal. The analysis shows that after moving from standard HF therapy to management based on information from the CardioMEMS HF System, patients from the study’s control group had a 48% reduction in HF hospitalisations. The CardioMEMS HF System was approved by the FDA in May 2014 based on clinical data from the landmark CHAMPION clinical study, which had an average follow-up duration of 15 months. The new publication provides results over an extended time period (an average of 31 months) demonstrating the long-term benefit of haemodynamic monitoring in reducing heart failure hospitalisation in these high risk patients.

When the treating physicians had access to the CardioMEMS PA pressure readings and managed patients based on pressures, patients experienced a statistically significant 48% reduction in HF hospitalisations. In addition, hospitalisation rates continued to remain low in the treatment group during the open access period demonstrating the durability of the effect of home haemodynamic monitoring.

The CHAMPION study originally demonstrated a statistically and clinically significant 28% reduction in the rate of HF hospitalisations at six months, and a 37% reduction in HF hospitalisations during an average follow-up duration of 15 months. This new long-term, prospective data further supports the effectiveness of the CardioMEMS system at reducing HF hospitalisations by demonstrating the system can provide physicians the opportunity to proactively manage their HF patients.