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Allegra™ Tavi System

Uncompromised Hemodynamics. By Design.

The ALLEGRA™ TAVI System TF has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas1-3.
The ALLEGRA™ TAVI System TF is a catheter-based transfemoral heart valve system. It is indicated for the treatment of severe calcified aortic valve stenosis in high risk patients with elevated surgical risk or in patients with a symptomatic degeneration of an aortic valve bioprosthesis.

ALLEGRA™ Transcatheter Heart Valve

> ALLEGRA™ has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas1-3
> The outstanding hemodynamics of the ALLEGRA™ are particularly important in small native annuli and surgical valves (ViV)
> Whatever the anatomic situation, coronary access must be maintained.
> Durability of a transcatheter heart valve is critically important in younger patients.

All about Hemodynamics

  1. 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.
     
  2. 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.
     
  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

  1. 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.
     
  2. 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.
     
  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 EOA can be 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.

  1. 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.
     
  2. In all studies conducted with ALLEGRA™ so far, there is a 0% incidence of coronary obstruction1-3.
     
  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

  1. 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.
     
  2. 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.
     
  3. 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

Non-clinical testing indicates that the ALLEGRA™ Transcatheter Heart Valve is MR Conditional.
A patient with these bioprosthesis can be scanned safely under the following conditions:
 
> Static magnetic field of ≤ 3 Tesla
> Spatial gradient field of ≤ 1500 Gauss/cm
> Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning
> Normal mode of MR system

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.
 
Source: ALLEGRA IFU chapter 9
 

 


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


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Allegra™
Uncompromised hemodynamics. By design.

1. Wenaweser et al, Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve, EuroIntervention 2016.
2. Lemos, Clinical performance of a novel transfemoral, supra-annular, early functional, retrievable transcatheter aortic valve system”, PCR London Valves 2017 presented at Late Breaking Trials.
3. Schaefer et al, Thirty-d ay outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study; EuroIntervention, 2019.
4. Data on file.
5. Sathananthan et al, Impact of implant depth on hydrodynamic function with the ALLEGRA transcatheter heart valve following valve-in-valve intervention. EuroIntervention 2019.
6. Data on file.
7. Data on file.
8. Christie GW, Barratt-Boyes BG. On stress reduction in bioprosthetic heart valve leaflets by the use of a flexible stent. Journal of cardiac surgery 1991;6:476-81.
9. Yap et al, Aortic valve replacement: is porcine or bovine valve better? 2013.
 
ALLEGRA is a trademark or registered trademark of NVT AG. ALLEGRA™ is CE Mark approved. Other cited trademarks are the property of their respective owners. Data on file at NVT AG for any sustained claims in this document. CAUTION: The law restricts these devices to sale by or on the order of a physician and these products are intended for the use by or under the direction of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Not available in the United States and any other country where applicable health authority product registration has not been obtained. Information contained herein only for presentation outside the US and France. ALLEGRA™ is a product of NVT AG. Blue Sail Medical Co., Ltd is the parent company of NVT AG and Biosensors Intl. and its affiliates are collaborating for the commercialization of the ALLEGRA™ device. © 2021 Biosensors Intl. Group. All rights reserved.

CAUTION: Please note that the following pages are exclusively reserved for Health Care Professionals in countries with applicable health authority product registrations. To the extent this site contains information intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions. Please contact your Biosensors International representative for availability or the products and registration status.

The law restricts these devices to sale by or on the order of a physician. Prior to use, it is important to read the "Instructions for Use" supplied with these devices for indications, contraindications, suggested procedures, warnings, and precautions.

Biosensors’ interventional cardiology products, including BioMatrix NeoFlex™, BioMatrix™ Alpha, BioFreedom™, BioFreedom™ Ultra, Chroma™, BioStream™, BMX-J®, BioPath™, Powerline™, RISE™ NC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT AG. Blue Sail Medical Co., Ltd is the parent company of NVT AG and Biosensors International Group, Ltd. and its affliates are collaborating for the commercialization of the ALLEGRA™ device.

BioMatrix NeoFlex, BioMatrix Alpha, BioFreedom, BioFreedom Ultra, Chroma, BioStream, BMX-J, BioPath, Juno, S-Stent, Powerline, Rise NC and Quadrature Link are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. ALLEGRA™ is CE Mark approved (CE 0124). All other cited trademarks are the property of their respective owners.