Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REPLY 200 · 1 trial · 1 indication
Evaluation of this outcome requires measuring the number of ventilation pauses and ventilation reductions detected during the same night using SDB Monitoring function or the reference in-lab PSG (clinical assessment).
The Event-based Positive Predictive Value (PPV)of breathing troubles is complementary to Sensitivity. It is the proportion of abnormal events appropriately detected by SDB Monitoring function compared to the total number of abnormal events detected by SDB Monitoring function.
| Arm | Type | Description |
|---|---|---|
| REPLY 200 implanted patients | EXPERIMENTAL | REPLY 200 implanted patients |
| Name | Type | Description |
|---|---|---|
| REPLY 200 | DEVICE | REPLY 200 pacemaker |
Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria: * Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines * Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker...
REPLY 200 is a pacemaker-based system used for monitoring sleep disordered breathing in patients with bradycardia. It is being evaluated for its performance in detecting this condition in individuals who require pacing therapy.
REPLY 200 is being developed by LivaNova PLC, a medical technology company traded on the NASDAQ under the ticker LIVN. The device is currently in clinical development for use in patients with bradycardia.
REPLY 200 is in Phase 3 clinical development. A Phase 3 trial evaluating its sleep disordered breathing monitoring function has been completed, though the device remains investigational and is not yet approved for commercial use.
REPLY 200 has been studied in a completed Phase 3 trial registered as NCT01537718, titled "Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker." The trial enrolled 40 participants with bradycardia at sites in France and Spain.
REPLY 200 is not FDA approved. It is an investigational device that has completed a Phase 3 clinical trial, but it remains in clinical development and has not received regulatory approval for marketing.