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The Only Bioabsorbable LAA Occluder

admin — Thu, 02 Jul 2009 11:33:42 +0000

Occlusion of the Left Atrial Appendage (LAA) has been shown to decrease the risk of stroke for patients with Atrial Fibrillation (AF). We offer the only bioabsorbable LAA occluder giving our patients confidence in effective, safe, and permanent results.

Atrial Fibrillation is a common arrhythmia in adults and an important cause of strokes. The Left Atrial Appendage is the site for thrombus formation in 90% of patients with AF. These patients are required to take anticoagulants (Coumadine) for prevention of clotting and therefore strokes. Anticoagulant control is difficult, requiring frequent laboratory testing.

Occlusion of the LAA prevents clot formation in the pouch-like structure and decreases the risk of stroke. Several studies have shown the effectiveness of various devices to occlude and obliterate the LAA; a prospective study has also shown the superiority of device occlusion compared with anticoagulants in stroke prevention. Several metallic devices have been used to occlude the Left Atrial Appendage; although most of them were effective, they had a small incidence of side-effects including perforations and embolization. Metallic devices are not ideal for LAA occlusion because damage can be caused by the stiffness of the wires and the hooks used for immobilization. In addition, many device sizes are required to accommodate the different shapes and sizes of the LAA.

The Transcatheter Patch is the best option for the occlusion of a structure such as the Left Atrial Appendage. Its balloon inflatable deployment method as well as its wireless design allows a single patch to take the size and shape of any LAA, decreasing the chance of partial occlusion and eliminating the need for device exchanges. The Transcatheter Patch is a soft device which cannot cause perforations. Furthermore it is made from bioabsorbable materials and is replaced by natural tissue over time, which prevents chronic erosions or other problems.

ButtonSeal

admin — Tue, 30 Jun 2009 05:48:15 +0000

The ButtonSeal is an occlusive device which has been in use, in its current form or that of earlier generations, since the late 1980’s.

ButtonSeal Information

Transcatheter Patch

admin — Tue, 30 Jun 2009 05:47:54 +0000

The Transcatheter Patch is the only approved (CE mark) device for heart defect correction which is made without wires (frameless).

Transcatheter Patch Information

Perimembranous VSD

admin — Tue, 30 Jun 2009 05:47:07 +0000

The Ventricular Septal Defect (VSD) is a very common heart defect and by far the most challenging. There are basically two types of ventricular deptal defects (VSD), the muscular and the peri-membranous. The muscular is the easier to close by a device since it is far away from critical structures (conduction system, valves) and has adequate healthy tissue in the surrounding area (good rim). Many devices including metallic devices have been used successfully for the correction of muscular VSD’s. The most common VSD is the peri-membranous one. It is usually very close to the aortic valve on the left side and the tricuspid valve on the right side; further the conduction system passes close to the VSD. Large perimembranous VSDs are sent to surgery with all the associated problems related to open heart surgery and are corrected by good surgeons with low mortality.

The results of metallic devices are mediocre to disastrous. The incidence of complete heart block after the use of a popular metallic device was 20% or 20 times more than Surgery in a European clinical trial. Use of this device has been abandoned and we believe that this will be the fate of any metallic device in this critical position. The Transcatheter Patch is an ideal device for peri-membranous VSD occlusion. Since the device is wireless, it cannot impinge on critical structures like the aortic valve and it is too soft to compress the conduction system. It is no surprise that no incidence of heart block or aortic insufficiency have been found in perimembranous VSD occlusion cases using the Transcatheter Patch. In addition, due to the unique design of the Transcatheter Patch, challenging VSDs such as in cases of Fallot Tetralogy, have been repaired. The Transcatheter Patch is CE-marked for VSD occlusion.