Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Emerge 1.20 mm PTCA Dilatation Catheter · 1 trial · 1 indication
Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure
| Arm | Type | Description |
|---|---|---|
| Emerge | EXPERIMENTAL | Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter |
| Name | Type | Description |
|---|---|---|
| Emerge™ 1.20 mm PTCA Dilatation Catheter | DEVICE | The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. |
Clinical Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index proc...
Emerge 1.20 mm PTCA Dilatation Catheter is used to enlarge the coronary luminal diameter in patients with Coronary Artery Disease. It is a percutaneous transluminal coronary angioplasty (PTCA) dilatation catheter designed for this purpose. The device is currently in Phase 3 clinical development.
Emerge 1.20 mm PTCA Dilatation Catheter is developed by Boston Scientific Corporation, a company publicly traded under the ticker symbol BSX. The device is being investigated for use in Coronary Artery Disease and is currently in Phase 3 clinical development.
Emerge 1.20 mm PTCA Dilatation Catheter is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed for this device in patients with Coronary Artery Disease.
Emerge 1.20 mm PTCA Dilatation Catheter has one completed clinical trial, NCT01635881, titled 'Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter'. This Phase 3 trial enrolled 60 participants with Coronary Artery Disease in the United States.
Emerge 1.20 mm PTCA Dilatation Catheter is not FDA approved. It is an investigational device currently in Phase 3 clinical development. A completed clinical trial, NCT01635881, has evaluated its use in Coronary Artery Disease, but regulatory approval has not been granted.