Amplatzer Piccolo™ Delivery System Model 9-PDS-04F-045 - Cardiac occluder delivery kit

Intended purpose

The Amplatzer Piccolo™ Delivery System is intended to facilitate the loading, delivery, and deployment of an Amplatzer Piccolo™ Occluder. It is indicated to facilitate the delivery of an Amplatzer Piccolo™ Occluder through the heart of a patient with a patent ductus arteriosus.

Functional description

The Amplatzer Piccolo Delivery System is prepared by flushing and wiping the catheter with sterile saline. The Tuohy-Borst valve is attached, and the catheter is advanced with a guidewire through the introducer sheath and across the Patent Ductus Arteriosus under imaging guidance. The occluder is prepared as per the instructions for use and advanced through the catheter to the PDA. Once the placement is confirmed, the occluder is released, after which the delivery wire and catheter are removed.