Description of the device
Device for occlusion of left atrial auricle is a percutaneous device for preventing embolization of blood clots from the left atrial auricle of patients with atrial fibrillation.
Device for occlusion of left atrial auricle completed by a delivery system.
The product is made of high-tech nitinol mesh on a complexly modeled frame, which is sent with a polyester fabric from the inside;
- The construction of the occluder consists of two disks, also construction is self-opening and self-centering.
- On the surface of the occluder there is a number of fixing elements which impede the migration of the product from the left atrial auricle.
The system of the delivery of the occluder of left atrial auricle (includes the transeptal introducer, the bougie for the delivery catheter, pusher of occluder of left atrial auricle).
For implantation of device for occlusion of left atrial auricle in X-ray conditions there are require the following materials:
Indications for use of the device for occlusion of left atrial auricle
The implantation of the occluder of left atrial auricle is indicated to prevent the development of thromboembolism of the arteries of the pulmonary circulation of patients with atrial fibrillation, by implanting the product into the left atrial auricle.
This device is intented for use in the following clinical situations:
- Permanent form of atrial fibrillation.
Continiously reccurent atrial fibrillation.
The implantation of the occluder of left atrial auricle:
- Patients under the risk of septic embolism;
- Persons with an uncontrolled course of an infectious disease;
- If the length of left atrial auricle is less than 10 mm;
- Patients with contraindications for endovasular interventions;
- In the presence of allergic reactions to the material of the product.
The product is disposable. The occluder of left atrial auricle does not have the property of maintainability.
The implantation of the occlder of left atrial auricle can only be performed by doctors who are familiar with the methods of performing endo-endovascular interventions (including the usage of this device) and provided with the awareness of possible complications, and only in the medical insitutes that are specially equipped to perform necessary operations in the event of complications. All manipulations should be carried out under fluoroscopic control, transesophageal or intracardiac echocardiography.