Device Dossier

9F Acuity Pro Guide Catheter - Catheter, intravascular, guiding

Device Dossier for 9F Acuity Pro Guide Catheter - Catheter, intravascular, guiding (Catheter, intravascular, guiding, Class III, sponsor Boston…

Intended purpose

The ACUITY Pro Lead Delivery System is intended to access the coronary venous system. The ACUITY Pro 9F Guide Catheter serves as a conduit for the delivery of contrast medium and devices, including implantable Boston Scientific coronary venous leads, introduced into the coronary venous system. The guide catheter may be used alone (9F) or in dual catheter delivery (9F with 7F).

Functional description

The 9F ACUITY Pro designed for venous use to provide a pathway through which contrast/devices, including left ventricular pacing leads can be introduced into the coronary venous system. It is designed to provide access to the coronary venous system, and may be used in conjunction with smaller appropriately sized catheters in a telescoping manner to improve the access and delivery capabilities of the system.

TGA Public Summary