Author(s): Kara Jones, Nova Szoka MD
Respicardia, Inc. received FDA approval for the remedē System on October 6, 2017.
The remedē System is an implantable nerve stimulator used to treat adults with moderate to severe central sleep apnea (CSA). The system consists of a battery-powered pulse generator which is implanted beneath the skin in the upper chest, and two transvenous wire leads that stimulate breathing. Programing the device is done via an external System Programmer and Programming wand.
While a patient is asleep, the system delivers a small electrical stimulus to the phrenic nerve causing the diaphragm to contract. The system has two modes: asynchronous and synchronous. Asynchronous therapy delivers pulses at a fixed rate, and synchronous therapy delivers a pulse only when a pause in breathing is detected. The system has safeguards to ensure it is only active while the patient is asleep.
The remedē System Pivotal Trial was a clinic trial supporting device approval; this study included 115 patients and measured the apnea hypopnea index (AHI) in adults with moderate to severe CSA. Results demonstrated a significant reduction in AHI in patients using remedē compared to the control group. After 6 months, AHI was reduced by at least half in 51 percent of patients with an implanted remedē System compared to 11 percent of patients in the control group.
FDA approved indications for use:
- Moderate to severe central sleep apnea (CSA) in adult patients
- Patients with active infection
- Patients known to need magnetic resonance imaging (MRI)