Ultraseal Left Atrial Appendage Closure
The patented technology of Ultraseal has been developed for transvenous closure of the left atrial appendage or left atrial appendage (LA). Percutaneous closure of the LE is a therapeutic alternative for patients with non-valvular Atrial Fibrillation and contraindication to anticoagulants.
Details of the product
The lobe and disc design includes a point of articulation between the two that acts as a Ultraseal a unique device on the market, and allows it to adapt naturally to any left appendage anatomy and angulation.
Alternative
- Disc
- PVA and polyester membrane.
- The disc is 6mm larger than the bulb.
- Articulating point
- Titanium.
- Lobe
- Round and atraumatic.
- Highly flexible nitinol structure.
- 12 radiopaque bulb anchor points (platinum-iridium).
The atraumatic lobe allows safe advancement into the LE, while the disc with its double sealing membrane ensures a high closure rate. ULTRASEAL is available in 10 sizes that cover virtually all patient diameters and anatomies.
Details of the product
- Left appendage closure device with lobe and membrane-covered disc design.
- Recoverable and repositionable.
- Compatible with 12Fr unique release system.
Technical Specifications
| General Characteristics | |
| Indication | Prevention of embolization of thrombi originating from LAA in patients suffering from non-valvular atrial fibrillation with contraindication to long-term anticoagulants. |
| Available measurements (bulb diameter) | 16, 18, 20, 22, 24, 26, 28, 30, 32, 34mm |
| Anchor points | 12 points, in section of the bulb, with radiopaque platinum-iridium markers |
| Self-expanding structure material | Nitinol (nickel + titanium) |
| Sealing layer material in wing/disc section | PVA and PET polyester |
| Joint point material | Titanium |
| Required sheath depth | 10 mm (for measurements 16, 18, 20, 22 and 24mm)
12 mm (for sizes 26, 28, 30, 32, and 34mm) |
| Bulb diameter / disc diameter ratio | 16 mm / 22 mm (measurement 16 mm)
18 mm / 24 mm (measurement 18 mm) 20 mm / 26 mm (measurement 20 mm) 22 mm / 28 mm (measurement 22 mm) 24 mm / 30 mm (measurement 24 mm) 26 mm / 32 mm (measurement 26 mm) 28 mm / 34 mm (measurement 28 mm) 30 mm / 36 mm (measurement 30 mm) 32 mm / 38 mm (measurement 32 mm) 34 mm / 40 mm (measurement 34 mm) |
| Radiopaque markers | Yes, platinum – iridium |
| System recovery and repositioning | Yes, possible before release |
Order information
| Reference ULTRASEAL | Bulb diameter | Diameter disc | release pod |
| LAA-16 | 16 mm | 22 mm | 12 Fr |
| LAA-18 | 18 mm | 24 mm | 12 Fr |
| LAA-20 | 20 mm | 26 mm | 12 Fr |
| LAA-22 | 22 mm | 28 mm | 12 Fr |
| LAA-24 | 24 mm | 30 mm | 12 Fr |
| LAA-26 | 26 mm | 32 mm | 12 Fr |
| LAA-28 | 28 mm | 34 mm | 12 Fr |
| LAA-30 | 30 mm | 36 mm | 12 Fr |
| LAA-32 | 32 mm | 38 mm | 12 Fr |
| LAA-34 | 34 mm | 40 mm | 12 Fr |
| Release system reference | Description | release pod |
| AC-12 0802 | Kit standard 12 Fr | Length 80cm
Special curve 45ºx45º |