News

Urgent Recall for Product Correction

Added: 20 May 2015

A serious safety concern has been identified during the preliminary primary data analysis from a clinical trial with ResMed ASV devices.

This trial investigated the effect of Adaptive Servo-Ventilation (ASV) therapy on the hospitalization and mortality rate of patients with a certain type of heart failure and moderate to severe predominant central sleep apnea.

 

The identified safety concern is a significant increase in the risk of cardiovascular death in patients with a certain type of heart failure being treated with Adaptive Servo-Ventilation.

 

There has been no malfunction or technical fault with the operation of the device; it operates correctly to treat central sleep apnea. The identified risk is with the use of ResMed ASV devices in this identified at risk population.

 

Please click here for answers to frequently asked questions to help you navigate the study results as it relates to you.

 

We recommend patients on ASV treatment to contact their prescribing physician.


For further information please refer to:

 

http://www.sleep.org.au/information/sleep-documents/resmed-ltd-serve-hr

http://www.resmed.com/au/en/consumer/news-and-information/news-releases/2015/phase-iv-serve-hf-study.html

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