Key features:

• Unique Braiding Technology: Ensures superior stretchability in long tunnels.
• Right Atrial Ball Connector: Acts as a welding and fixation point, offering reliability, rotation, and reduced edges compared to traditional screw hubs.
• Easy and Safe Delivery System: Allows the occluder to rotate up to 50° without force.

Enhanced Engineering

The Occlutech PFO Occluder is engineered with precision and improved features, available in five sizes and two lengths. Enhanced ball connector design offers safer locking and unlocking functions, and the device is easy to use and reliable.

Delivery System: Pistol Pusher

The delivery system, known as the Pistol Pusher, comes in various lengths to accommodate different patient needs:

• 55 PP 090 or 55 PP 090L: 120 or 150 cm
• 55 PP 125 or 55 PP 125L: 120 or 150 cm
• 55 PP 165 or 55 PP 165L: 120 or 150 cm
• 55 PP 185 or 55 PP 185L: 120 or 150 cm
• 55 PP 210 or 55 PP 210L: 120 or 150 cm

Argumentation Against Amplatzer PFO Occluder

The Occlutech PFO Occluder offers several advantages over the Amplatzer PFO Occluder by Abbott USA, which has not seen significant innovation since its CE mark approval in 1998. Key points include:

1. No Recent Innovation: Amplatzer’s technology is over 20 years old, lacking updates to address modern medical needs.
2. Screw-Connector Issues: The screw-connector of Amplatzer forces the septum at a rigid 90° angle, which can be problematic during implantation.
3. Thrombogenic Concerns: The screw itself can be thrombogenic, increasing the risk of thrombus formation.
4. Procedure Time: Occlutech offers a shorter procedural and fluoroscopy time compared to Amplatzer.
5. Delivery System: The Amplatzer delivery system has a less transparent loader, leading to a higher risk of air embolisms.

Clinical Studies and Efficacy

The Occlutech PFO Occluder has demonstrated superior safety and efficacy in clinical studies, showing lower rates of complications and improved patient outcomes. The device is engineered to provide a reliable and effective solution for PFO closure, making it the preferred choice for many cardiologists.

A Patent Foramen Ovale (PFO) is a heart defect that occurs when the foramen ovale, a small flap-like opening between the atria of the heart, fails to close after birth. This defect can lead to an increased risk of stroke due to blood clots passing from the right to the left atrium and potentially traveling to the brain.

PFO Morphology

The size and length of the PFO tunnel increase with age. The average PFO diameter is 51 mm, ranging from 34 mm in the first decade to 58 mm in the tenth decade of life. The diameter is larger in women (56 mm) compared to men (47 mm). PFOs larger than 4 mm are associated with a higher risk of recurrent strokes. The extent of septal overlap determines the PFO tunnel length, varying from 3 to 18 mm, with an average of 8 mm. Tunnels longer than 8 mm are considered complex PFOs.

Occlutech PFO Occluder Design

The Occlutech PFO Occluder is designed with a focus on flexibility and elasticity, particularly suited for long tunnel alignments.