Cormos® Medical
LAA-Occlusion Set
Catheter-based (interventional) occluder for closure of the left atrial appendageClinical relevance
and LAA occluder
In western industrialized countries, about 1.5% of the population are afflicted with atrial fibrillation (AF), the most frequent form of cardiac arrhythmia. This accounts for around 1.2 million people in Germany. This primarily affects people over the age of 80 who even account for 10-17%. Based on the demographic development, the percentage of people with AF will double in the coming decades. AF slows down the blood flow in a part of the heart, the so-called Left Atrial Appendage = LAA. Besides the static blood flow and the rough, all-round structure, this appendage offers an ideal environment for thrombogenesis and, thus, complications. People with AF have an up to 15-times higher risk of suffering a stroke.
As the means of choice for stroke prophylaxis, blood clotting inhibitors are used, which means a lifelong medication treatment. An effective method instead is a catheter-based closure of the LAA with a so-called occluder.
Cormos® Medical LAA Occluder has been developed for the permanent, interventional closure of the left atrial appendage. Two versions of the Cormos® Medical LAA Occluder (type I with disc, type II without disc) are available in different sizes, which cover the complete spectrum of atrial appendage morphologies. The Cormos® Medical LAA Occluder will be offered in the Cormos® Medical LAA Occlusion Set together with the Cormos® Medical bit wire.
Characteristics Cormos® Medical LAA Occlusion Set
Two models
with and without proximal disc
Cormos® Medical Steerable Introducer
One delivery system for both product types
Precise placement
Precise placement and repositioning in the left atrial appendage with exit in 4 phases
Cormos® Medical bit wire
Improved retractability of the Cormos® Medical LAA Occluder in every phase of the implantation
Unique anchoring
Innovative anchorage by means of J-hooks
Flexible length adjustment
The elastic distal end permits an individual length adjustment to the LAA
Two models
With and without proximal disc
Cormos® Medical LAA-Occluder has been developed in 2 versions: type I with proximal disc (Tab. 1) and type II without proximal disc (Tab. 2). These types are available in different sizes. This covers the broad spectrum of LAA morphologies.
Cormos® Medical LAA-Occluder Typ I: LAA-Occluder with disc
| Size | ø bracket (mm) | ø disc (mm) | Length (mm) |
|---|---|---|---|
| 1 | 18 | 21.1 | 12.2 |
| 2 | 20 | 23.4 | 13.6 |
| 3 | 22 | 25.8 | 14.9 |
| 4 | 24 | 28.1 | 16.3 |
| 5 | 26 | 30.4 | 17.6 |
| 6 | 28 | 32.8 | 19.0 |
Cormos® Medical LAA-Occluder Typ II: LAA-Occluder without disc
| Size | ø bracket (mm) | Length (mm) |
|---|---|---|
| 0 | 16 | 10.6 |
| 1 | 18 | 11.9 |
| 2 | 20 | 13.2 |
| 3 | 22 | 14.5 |
| 4 | 24 | 15.9 |
| 5 | 26 | 17.2 |
| 6 | 28 | 18.5 |
| 7 | 30 | 19.8 |
| 8 | 32 | 21.1 |
| 9 | 35 | 23.1 |
Cormos® Medical Steerable Introducer
One delivery system for both product types
The Cormos® Medical Steerable Introducer is a compatible delivery system for both Cormos Medical LAA Occluders (Type I/II). The delivery system is available in two sizes (more) with the following recommended size of the delivery system depending on the occluder size:
Cormos® Medical LAA-Occluder
Cormos® Medical Steerable Introducer
| Size | Recommended size |
|---|---|
| 0 – 4 | 12.0 F; 13.8 F |
| 5 – 9 | 13.8 F |
Precise placement
Precise placement and repositioning in the left atrial appendage with exit in 4 phases
Cormos® Medical bit wire
Improved retractability of the Cormos® Medical LAA Occluder in every phase of the implantation
The Cormos® Medical bit wire has an innovative closure system, which facilitates the stepless introduction of the LAA occluder in the delivery system. This supports a repositioning or retraction of the Cormos® Medical LAA Occluder in every exit phase before the final release into the left atrial appendage.
Unique anchoring
Innovative anchorage by means of J-hooks
The Cormos® Medical LAA-Occluder is anchored firmly by 15 and 21 hook elements, respectively, in the left atrial appendage. The hooks are bent backward in a J-shape by slightly more than 180° toward the occluder’s center line. This permits an improved transport of the occluder in the delivery system without the hooks possibly getting stuck in the interior wall of the delivery system.
In addition, the design of the hook prevents a perforation of the heart sac almost entirely.
Flexible length adjustment
The elastic distal end permits an individual length adjustment to the LAA
The flexible distal end of the Cormos® Medical LAA-Occluders, by virtue of its unique structure, allows for an individual adjustment to the length of the left atrial appendage.
Availability
The Cormos® Medical LAA-Occlusion Set is currently in the certification process and is not yet available on the market.
