Occlutech ASD Occluder and Occlutech Pistol Pusher – P200032
This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.
Product Name: Occlutech Atrial Septal Defect (ASD) Occluder
PMA Applicant: Occlutech Holding AG
Address: Feldstrasse 22, 8200 Schaffhausen, Switzerland
Approval Date: December 29, 2023
Approval Letter: Approval Order
What is it?
The Occlutech ASD Occluder is a permanent implant intended to treat an atrial septal defect (ASD). The device has two umbrella-shaped flexible discs with a connection in the middle.
How does it work?
A doctor inserts the delivery catheter into a vein in the groin and pushes it forward to reach the heart. Through the catheter, the doctor delivers the Occlutech ASD Occluder to the location of the hole in the upper areas of the heart. When the device is carefully positioned in the ASD, the two discs cover both sides of the atrial septum, closing the hole. After a few months, the device will be covered by a thin layer of tissue.
When is it used?
The Occlutech ASD Occluder is used in people who have an ostium secundum-type ASD (a type of hole in the heart in the middle of the atrial septum), and the ASD allows too much blood to travel to the right side of the heart (right ventricular volume overload).
What will it accomplish?
In a clinical study comparing the Occlutech ASD Occluder to another transcatheter ASD occluder approved by the FDA, 116 people were randomized to the Occlutech ASD Occluder group and 60 people were randomized to the second ASD occluder group. About 110 people who received the Occlutech ASD Occluder had their ASD closed. Successful closure means that patients did not:
- Have a large or moderate residual shunt (redirection of blood flow in the heart from the normal flow after the closure of the heart defect)
- Any major issues or problems (complications)
- Additional surgery
- Device embolization (unintended movement of the device to another part of the body) one day after the procedure
By six months, the ASDs of about 95 people had completely closed, meaning there was no residual shunt.
There were no deaths during the study. Some patients experienced complications such as:
- Headache
- Bruising where the catheter is placed in the leg
- Irregular heartbeat
- Infections
- Device embolization
Major complications related to the procedure can include:
- Death
- Stroke
- Cardiac perforation (a hole made in the heart) with tamponade
- Endocarditis
- Additional surgery
- Pericardial effusion (buildup of too much fluid in the sac around the heart) with tamponade
- Arrhythmia requiring major treatment
- Device embolization requiring surgery
When should it not be used?
The Occlutech ASD Occluder should not be used in patients who:
- Have extensive problems with the structure of the heart at birth which can only be repaired with heart surgery.
- Have had sepsis within one month before implantation, or any infection throughout the body that cannot be successfully treated before the device is placed.
- Have a bleeding disorder, untreated ulcer, or any other problems with aspirin therapy because it may be harmful to the person, unless another medicine that reduces blood clotting in an artery, vein, or the heart can be given for six months.
- Have shown blood clots in the heart, especially a blood clot in the upper left chamber of the heart.
- Whose size is too small for a test to take pictures of the heart to check for problems by passing through the throat or catheter size, or whose condition would cause the person to be at increased risk for a procedure passing a thin tube into the right or left side of the heart.
- Where the spaces around the defect are less than five millimeters to the largest vein of the heart, outer part of the largest vein in the body located in the belly, valves connecting the upper chambers to the lower chambers of the heart, or vein of the higher right part of the lung that supplies blood to the left chamber of the heart.
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Labeling- Instructions for Use
- Labeling Part 2- Patient Brochure
- PMA Database entry