ENP Newswire -
Release date- 28052014 -
The device allows health care professionals to monitor the condition of their patients remotely.
About 5.8 million people in
The CardioMEMS HF System is used by the patient in the home or other remote location. This is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic and mean PA pressures. The PA pressure data are reviewed by physicians who can make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of reducing hospitalization due to heart failure.
The system consists of three parts:
.A battery-free Implantable Sensor/Monitor implanted permanently in the PA;
.Delivery System, a transvenous catheter designed to deploy the Implantable Sensor, within the distal PA; and
'Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,' said
To support the approval, the company submitted data from its pivotal clinical study. Concerns about the clinical study were discussed at the
The clinical study, in which 550 participants had the device implanted and were randomized into either the control group or investigational group, showed a clinically and statistically significant reduction in heart failure-related hospitalizations for the participants whose doctors had access to pulmonary artery pressure data. Of the participants who had the device implanted (or in whom there was an attempt to implant the device), 98.6 percent were free from device/system-related complications at six months. Of the devices implanted, 100 percent were operational at 6 months, and there were no device explants or repeat implants during this time period.
The CardioMEMS HF System is manufactured by
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