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| Philips' cardiac ultrasound tool HeartModel--Courtesy of Philips (video still) |
Royal Philips ($PHG) said it is working with ResMed ($RMD) to analyze study data from mid-May showing that the latter company's Adaptive Servo-Ventilation (ASV) central sleep apnea treatment worsens cardiovascular mortality for those in a particular subset of chronic heart failure data. Philips has a similar device, which it said is contraindicated in the relevant population with increased mortality: moderate to severe central sleep apnea patients with symptomatic chronic heart failure and left ventricular ejection fraction of less than or equal to 45%.
The Dutch conglomerate said that in addition to working with ResMed to review its own data, it is evaluating the postmarket surveillance data, public adverse event data and other public data to try to identify and assess any other safety concerns. The safety precaution extends to Philips BiPAP autoSV and BiPAP autoSV Advanced devices.
The Philips sleep apnea devices in question are indicated to provide noninvasive ventilatory support to adult patients with obstructive sleep apnea and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing. They are not approved to treat heart failure. The ResMed SERVE-HF, which reported the increase of mortality in this population, was designed to show reduced mortality and morbidity in patients with symptomatic chronic heart failure with use of its ASV therapy.
The ResMed data showed that in the patient population with LVEF at or below 45%, 10% of the ASV group experienced a cardiac event, compared to 7.5% for the control group.
"Philips is actively evaluating the information provided by ResMed and examining if this might impact the medical care of patients who use Philips BiPAP autoSV/BiPAP autoSV Advanced devices," the company responded in a statement.
"As part of this ongoing investigation, we are working with ResMed in order to better understand their study data. We are also evaluating post market surveillance data, public adverse event data and other published data to identify and assess other safety concerns that may be present," Phillips concluded.
In a bit of good news from Philips, it launched cardiac ultrasound tool HeartModel. It bring 3-D imaging to the heart and is intended to offer reproducible ultrasound results and fast exam times. Exams with HeartModel are reported three to 6 times faster than conventional 2-D exams in gathering left ventricular and atrial dimensions as well as volumes. The technology is part of the Epiq 7 ultrasound system.
"Health systems are constantly looking for solutions to provide the most efficient and effective way to an accurate diagnosis," said Dr. Ivan Salgo, senior medical director of cardiovascular ultrasound at Philips, in a statement. "We're using automatic quantification and intelligence and our renowned image quality to bring more diagnostic confidence to cardiac procedures and to create more reproducible results."
- here are the sleep apnea and heart imaging Philips statements