Philips—Various Adaptive Servo-Ventilators: ResMed Warns of Increased Risk of Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Left Ventricular Ejection Fraction
June 10, 2015 | Risk Management News
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In a May 28, 2015, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital and an Urgent Field Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM), Philips states that ResMed has issued an Urgent Field Safety Notice that described a statistically significant 2.5 % absolute increased annual risk of cardiovascular mortality for those randomized to a ResMed ASV therapy compared to the control group. In the patient population with reduced left ventricular ejection fraction (LVEF ≤ 45%), 10.0% of the ASV group experienced a cardiovascular death each year compared to 7.5% of the control group, representing a 33.5% relative increased risk of cardiovascular mortality (HR=1.335, 95%CI=(1.070, 1.666), p‐value= 0.010). Philips states that it is evaluating the information provided by ResMed and determining...