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Allegra Valve in Valve

ALLEGRA™ for Valve-in-Valve Maximizing the effect in small annuli.

The outstanding hemodynamics of the ALLEGRA™ are particularly important in small native annuli and surgical valves (ViV).

With its supra-annular design, excellent hemodynamics and radiopaque gold markers, ALLEGRA™ is also an excellent choice for implantation into a degenerative surgical biological aortic valve.

Its dependable release mechanism facilitates straightforward, safe and effective implantation while maintaining biological circulation.

These features enable safe and expedient implantation on the first attempt

Maximizing the effect in small annuli
Patients with small annuli derive particular benefit from the use of the ALLEGRA™ valve, due to the combination of wide valve opening and supra-annular valve plane. 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 effective orifice areas can be achieved1,3.
 
Excellent choice for Valve-in-Valve procedures
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.

Better in-vitro hemodynamic performance
ALLEGRA™ shows better in-vitro hemodynamic performance than other TAVI devices in the Valve-in-Valve setting. In-vitro comparisons have shown higher effective orifice area (EOA) compared to other intra-annular and supra-annular valves4,5.

Clinical outcomes

The VIVALL study¹ analyzed the technical feasibility, safety and performance of an ALLEGRA™ implantation after a surgically implanted aortic valve had failed.
The outcomes² confirm that ALLEGRA™ is particularly well-suited for implantation in degenerated surgical biological aortic valves.
 

11.6 ± 3.7 mmHg

The pre-procedural mean pressure gradient3 of 37.1 ± 13.8 mmHg was reduced to 11.6 ± 3.7 mmHg after the operation

0 %

total mortality

0 %

need for new pacemaker

1.4 ± 0.52 cm²

The effective opening surface increased from a baseline of 1.18 ± 0.58 cm² to 1.4 ± 0.52 cm² after 30 days


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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™ Alpha, BioFreedom™, BioFreedom™ Ultra, BMX-J®, RISE™ NC and RISE™ SC, are not available for sale in the United States and certain other countries. ALLEGRA™ is a product of NVT GmbH. Blue Sail Medical Co., Ltd is the ultimate parent company of NVT GmbH and Biosensors International Group, Ltd. and its subsidiaries are collaborating for the commercialization of the ALLEGRA™ device.

BioMatrix Alpha, BioFreedom, BioFreedom Ultra, BMX-J, Juno, S-Stent, Rise NC and Rise SC are trademarks or registered trademarks of Biosensors International Group, Ltd. ALLEGRA is a trademark or registered trademark of NVT AG. All other cited trademarks are the property of their respective owners.