Uncompromised Hemodynamics. By Design.
ALLEGRA™ Transcatheter Heart Valve
All about Hemodynamics
All about hemodynamics. The ALLEGRA™ has a unique self-expanding stent frame with convex and concave areas that provide high EOA (effective orifice areas), even in small annuli1-3. This unique stent shape also means that there is no interaction with the ascending aorta.
The ALLEGRA™ stent design incorporates a tailored radial force distribution with high radial force in the sealing area to achieve secure anchoring and less radial force in the outflow section. This enables a wider valve opening at the commissures and contributes to the large EOA and low mean pressure gradient1-3.
- The ALLEGRA™ is a supra-annular valve. The new valve plane sits above the constrained and diseased native valve. This supra-annular valve position also contributes to the large EOA and low mean pressure gradient1-3.
Maximizing the effect in small annuli
The design features of the ALLEGRA™ make it an excellent choice for Valve-in-Valve procedures with low frame height and unique visualization of the new valve plane by 6 radiopaque gold markers.
ALLEGRA™ shows better in-vitro
Hemodynamic performance than other TAVI devices in the Valve-in-Valve setting. In-vitro comparisons have shown higher EOA compared to other intra-annular and supra-annular valves4,5.
The ALLEGRA™ can be used with annular diameters as low as 19 mm in native valves and 16.5 mm in surgical valves. Even in these very small annuli, low single digit mean pressure gradients and high EOA can be achieved1,3.
The ALLEGRA™ can be used with annular diameters as low as 19 mm in native valves and 16.5 mm in surgical valves. Even in these very small annuli, low single digit mean pressure gradients and high EAO can ve achieved1,3.
Maintaining coronary access
In patients with wide coronary sinuses, intra-annular fixation of the ALLEGRA™ and the absence of any interaction with the ascending aorta both ensure continued access to the coronary ostia.
In patients with narrower coronary sinuses, the outflow section of the ALLEGRA™ has large stent cells which further facilitate coronary access. The stent frame can be safely crossed with standard interventional catheters including up to 12 Fr6.
In all studies conducted with ALLEGRA™ so far, there is a 0% incidence of coronary obstruction1-3.
- In patients with very low-lying coronary ostia, the 6 easily visualized gold markers which mark both the new valve plane and the top of the 12 mm high sealing skirt allow the operator to accurately position the valve taking into account the coronary heights.
Durability by design
The stent frame of the ALLEGRA™ allows pole movement which reduces leaflet stress. Pole movement allows the commissural points of the leaflets to move with every cardiac cycle and reduces stress to the leaflets7. In the surgical aortic valve literature reduction of leaflet stress is associated with increased durability8.
For the ALLEGRA™ bovine pericardium is used for all tissue components. Bovine pericardium was chosen as it has an excellent performance profile with very good biocompatibility, outstanding hemodynamic characteristics, low complication rates and extensive data on durability from the surgical literature9.
- The ALLEGRA™ bovine pericardium is treated to reduce calcification potential. The protective treatment is based on proven techniques such as the elimination of the phospholipid layer of the pericardial cells and the reduction of the glutaraldehyde free bonds. Both of these treatments offer anti-calcification characteristics to the pericardium.
MRI Safety Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Bioprosthesis.
ALLEGRA™ Delivery System TF
ALLEGRA™ comes with a bespoke delivery system for occlusion free Permaflow™ implantation technique.
The ALLEGRA™ delivery system with its patented Permaflow™ principle facilitates a precise and controlled release of the bioprosthesis in three steps.
- The ALLEGRA™ delivery system offers an occlusion free Permaflow™ deployment technique with no hemodynamic compromise during implantation
- The ALLEGRA™ delivery system incorporates an easy 3-step deployment
- A highly flexible 15 Fr catheter with an 18 Fr valve cartridge allows enhanced cross-ability through the aortic arch
- A user-friendly delivery handle with the unique ‘‘Squeeze-to-release’’ mechanism
- Visibility for precise implantation is important