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SITELINE 2 Polyurethane · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| SITELINE 2 Polyurethane (pacing lead) | DEVICE | SITELINE 2 Polyurethane (pacing lead) |
Inclusion Criteria: * Patients indicated for dual chamber pulse generator implant, where the pulse generator is capable of meeting the requirements of this investigational protocol * Patients selected must have the study lead as the initial implant of a permanent pacing lead in both the right atriu...
SITELINE 2 Polyurethane is an investigational medical device being studied for the treatment of bradycardia, a condition characterized by an abnormally slow heart rate. It is being developed by Boston Scientific Corporation (BSX) and is currently in Phase 3 clinical development.
SITELINE 2 Polyurethane is being developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical trials to evaluate the device for use in patients with bradycardia.
SITELINE 2 Polyurethane is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. A Phase 3 clinical trial for the device has been completed, but it remains under investigation for the treatment of bradycardia.
SITELINE 2 Polyurethane has one completed Phase 3 clinical trial, registered under the identifier NCT00180284. The trial enrolled 200 participants with bradycardia in the United States, with a minimum age of 18 years. The study was not randomized, double-blind, or controlled.
SITELINE 2 Polyurethane is not FDA approved. It is an investigational device currently in Phase 3 clinical development for the treatment of bradycardia. A Phase 3 trial has been completed, but the device has not yet received regulatory approval for commercial use.