Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
7F Ensure Medical Vascular Closure Device · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | Vascular Closure Device |
| Name | Type | Description |
|---|---|---|
| 7F Ensure Medical Vascular Closure Device | DEVICE | Vascular Closure Device |
Inclusion Criteria: * Patient is between 18 and 85 years of age * Patient/legal representative provides written informed consent * Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure * Patient is able to undergo emergent vascular surgery if a complication relate...
The 7F Ensure Medical Vascular Closure Device is an investigational device used in percutaneous coronary transluminal angioplasty, a procedure to treat coronary arteriosclerosis. It is designed to achieve hemostasis, or stop bleeding, at the vascular access site following the procedure.
The 7F Ensure Medical Vascular Closure Device is developed by Cardinal Health, Inc., which trades on the New York Stock Exchange under the ticker CAH. The device is currently in clinical development for cardiovascular applications.
The 7F Ensure Medical Vascular Closure Device is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
The 7F Ensure Medical Vascular Closure Device has one completed clinical trial, the ECLIPSE Feasibility Trial (NCT00574691), conducted in Germany. This Phase 1 study enrolled 93 participants with coronary arteriosclerosis undergoing percutaneous coronary angioplasty.
The 7F Ensure Medical Vascular Closure Device is a specific size variant of the Ensure Medical Vascular Closure Device platform. The '7F' designation refers to the French catheter size it accommodates, indicating the device is designed for 7 French access sites.