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Resources to Support the Patient Pathway

Patient Selection – Who is the right patient for remedē?

Indication:

The remedē System is FDA approved for the treatment of moderate-to-severe Central Sleep Apnea (CSA) in adult patients’ with:

  • No requirement to have tried and failed other therapies for CSA
  • No upper limit of Apnea Hypopnea Index (AHI)
  • No upper limit of patient Body Mass Index (BMI)

Contraindication:

The remedē System is contraindicated for the following:

  • Patients with an active infection
  • Patients known to require Magnetic Resonance Imaging

Appropriate candidates for the remedē System may have events other than central apneas noted during the sleep study

AHI breakdown chart

Patients for remedē therapy should have moderate-to-severe CSA with > 50% of apneas being central

In the remedē Pivotal Trial, patients had obstructive apneas that made up ≤ 20% of apneas1

Hypopneas may be central or obstructive in nature and do not exclude patients for remedē therapy

Patients who should be considered for PNS:

  • CSA patients who have tried and cannot tolerate mask-based therapies
  • CSA patients with persistently high AHI despite mask therapy
  • CSA patients who have heart failure with reduced LVEF (<45%)

Once patients are identified for remedē therapy, referral to the implanting cardiac electrophysiologist is the next step in the patient pathway.

Download Implant Referral Template

remedē Patient Selection Pathway Example

Patient Selection Pathway
  1. Costanzo, et al. Lancet 2016; 388: 974–82.