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EASYTRAK 3 Downsize Lead · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| EASYTRAK 3 Downsize Lead | DEVICE | EASYTRAK 3 Downsize Lead |
Inclusion Criteria: * Must be indicated for a Guidant CRT-P or CRT-D device * Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment * Age 18 or above, or of legal age to give informed consent specific to state and national law * Willing and capable of providing informed consen...
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EASYTRAK 3 Downsize Lead is an investigational device being studied for use in heart failure. It is a cardiac lead designed for implantation in patients with heart failure. The device is currently in clinical development and has completed a Phase 2 trial.
EASYTRAK 3 Downsize Lead is 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 research to evaluate the safety and effectiveness of this cardiac lead for heart failure.
EASYTRAK 3 Downsize Lead is in Phase 2 clinical development. It is an investigational device and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to assess its use in patients with heart failure.
EASYTRAK 3 Downsize Lead has been studied in one completed clinical trial, identified as NCT00384722. This Phase 2 trial enrolled 70 participants with heart failure in the United States. The trial was uncontrolled and did not use randomization or blinding.
EASYTRAK 3 Downsize Lead is not FDA approved. It is an investigational device currently in clinical development. A Phase 2 clinical trial has been completed, but the device has not received marketing authorization from the U.S. Food and Drug Administration.