The FDA has granted Respicardia, a company out of Minnetonka, Minnesota, approval to introduce its Remedē implantable sleep apnea treatment system. The Remedē treats sleep apnea by stimulating one of the phrenic nerves that regulates the activity of the diaphragm. People with central sleep apnea exhibit shallow breaths and/or pauses in breathing that can have a terrible effect on their sleep quality and, as it turns out, their overall cardiovascular health, and increase their chances for obesity and diabetes. The poor control of the diaphragm in such patients is caused by the brain sending improper signals. Restoring normal and regular breathing by compensating for such poor signals should help to reduce or alleviate a number of complications that arise from long term sleep apnea.
The Remedē system consists of an implantable neurostimulator, electrode leads to sense phrenic nerve activity and to stimulate it, and a computer tablet to program and configure the implant for individual patient needs. People implanted with the system may be confused for pacemaker patients, since the implants look nearly identical. The leads, though, instead of going to the heart are snaked to penetrate and be located within blood vessels close to a phrenic nerve (left or right). From there, the implant can detect the electrical signals that the brain passes to the diaphragm to make the lungs breathe, adjusting its own stimulation in order to compensate for weak and poorly timed breaths.
Here’s some details, according to the FDA, about the study that led to the approval:
The FDA evaluated data from 141 patients to assess the effectiveness of the Remedē System in reducing apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes. After six months, AHI was reduced by 50 percent or more in 51 percent of patients with an active Remedē System implanted. AHI was reduced by 11 percent in patients without an active Remedē System implanted.
The most common adverse events reported included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The Remedē System should not be used by patients with an active infection or by patients who are known to require magnetic resonance imaging. This device is not intended for use in patients with obstructive sleep apnea, a condition in which the patient attempts to breathe, but the upper airway is partially or completely blocked.
Product page: Remedē System…
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