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ALLEGRA Transcatheter Heart Valve

UNCOMPROMISED HEMODYNAMICS. BY DESIGN.

The ALLEGRA™ Transcatheter Heart Valve (THV) has been designed for uncompromised hemodynamic performance with single digit mean pressure gradients and high effective orifice areas.1-3

The ALLEGRA™ THV 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.



UNIQUE STENT FRAME

The ALLEGRA™ maximizes the effective orifice area.
The self-expanding unique stent frame of ALLEGRA™ has convex and concave area for high effective orifice area.


ANCHORING AND SEALING

The ALLEGRA™ stent frame has tailored radial force for effective anchoring and sealing in the annulus.
The stent frame design provides high radial force in the sealing area and less radial force at the outflow.


WIDER VALVE OPENING

The ALLEGRA™ is a supra-annular valve with a flexible stent outflow for wider valve opening.
The flexible stent outflow allows for wider valve opening for large EOA and low mean pressure gradient.1-3


SMALL ANNULI AND VALVE-IN-VALVE

ALLEGRA™ maximizes the hemodynamic performance in small native annuli and in Valve-in-Valve procedures.4-5

With a wide valve opening and supra-annular valve position, the patient can benefit from high EOA and low mean pressure gradients.1-3 Minimum treatable annulus diameter is 16.5 mm.


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DURABILITY

The ALLEGRA™ stent frame allows for flexing at the commissural fixation points.
Flexible commissural fixation points reduce stress to the leaflets in every cardiac cycle and are associated with increased durability.20,21


TISSUE PROTECTION

The ALLEGRA™ is protected by TissGUARD™ for long-term valve function.

TissGUARD™ technology combines the bovine pericardial tissue anti-calcification treatment with leaflet stress-reduction effects of flexible commissural fixation points resulting in long-term valve function.


CORONARY ACCESS

ALLEGRA™ maintains access to the coronary ostia for future interventions.
The 6 radiopaque gold markers highlight where the top of the sealing skirt is and ensures precise implantation for future coronary access.


FLOW DYNAMICS

ALLEGRA™ shows in-vitro a more physiological flow pattern than other valves.
Achieving a physiologic flow pattern results in lower gradients, less platelet activation, hemolysis and minimal paravalvular leak resulting in a longer lasting valve.23

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ALLEGRATM THV SPECIFICATIONS

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NT-DB-120101-EN-02_2025-02, NT-DB-110101-EN-01_2021-02, 11881-000-EN - Rev.05

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-day 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. J.A. Baz Alonso et al ,First-In-Human Experience of the New Fully Repositionable IMPERIA Delivery System to Implant the ALLEGRA Transcatheter Heart Valve in Patients With Severe Calcific Aortic Stenosis or Degenerated Surgical Bioprosthesis: Thirty-Day Results of the EMPIRE I Study” Structural Heart 9, 2025
7. Leone PP et al, TAVI-SMALL Investigators. Prosthesis-patient mismatch after transcatheter implantation of contemporary balloon-expandable and self-expandable valves in small aortic annuli. Catheter Cardiovasc Interv. Nov., 2023;
8. Corevalve - SURTAVI: N.M. Van Mieghem, “Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients 5-Year Outcomes of the SURTAVI Randomized Clinical Trial” – JAMA Cardiol. 2022;7(10):1000-1008. doi:10.1001/jamacardio.2022.2695
9. Sapien XT, Sapien 3 - PARTNER 2 Trial and Registry: J. Ternacle, “Prosthesis-Patient Mismatch After Aortic Valve Replacement in the PARTNER 2 Trial and Registry” – JAMA Cardiol. 2022;7(10):1000-1008. doi:10.1001/jamacardio.2022.2695;
10. Evolut™ R, PRO, PRO+ - STS/ACC TVT Registry: G.H. L. Tang “Outcomes of Prosthesis-Patient Mismatch Following Supra-Annular Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry” – JACC Cardiovasc Interv 2021 Volume 14, Issue 9, 10 May 2021, Pages 964-976-10.1016/j.jcin.2021.03.040;
11. Corevalve - Retrospective Analysis: M. D. C. Leon del Pino “Prosthesis-patient mismatch after transcatheter aortic valve replacement: prevalence and medium term prognostic impact” – The International Journal of Cardiovascular Imaging – 2019 Volume 35, pages 827–836, (2019) - 10.1007/s10554-018-01519-z;
12. Sapien, Sapien XT, Sapien 3 - Single-center registry: N. Schofer “Prosthesis-patient mismatch after transcatheter aortic valve implantation: prevalence and prognostic impact with respect to baseline left ventricular function” – Eurointervention - 2019 Mar 20;14(16):1648-1655. doi: 10.4244/EIJ-D-18-00827;
13. Portico™ - Single-center registry: N. Schofer “Prosthesis-patient mismatch after transcatheter aortic valve implantation: prevalence and prognostic impact with respect to baseline left ventricular function” – Eurointervention - 2019 Mar 20;14(16):1648-1655. doi: 10.4244/EIJ-D-18-00827;
14. Corevalve, Evolut™ R, Acurate neo™ - Single-center registry: N. Schofer “Prosthesis-patient mismatch after transcatheter aortic valve implantation: prevalence and prognostic impact with respect to baseline left ventricular function” – Eurointervention - 2019 Mar 20;14(16):1648-1655. doi: 10.4244/EIJ-D-18-00827;
15. Sapien THV, Sapien XT, Sapien 3 - Propensity Matched: T. Okuno “Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement With Supra-Annular and Intra-Annular Prostheses” – JACC Cardiovasc Interv 2019 Volume 12, Issue 21, 11 November 2019, Pages 2173-2182 - https://doi.org/10.1016/j.jcin.2019.07.027;
16. Evolut™, CoreValve - Propensity Matched: T. Okuno “Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement With Supra-Annular and Intra-Annular Prostheses” – JACC Cardiovasc Interv 2019 Volume 12, Issue 21, 11 November 2019, Pages 2173-2182 - https://doi.org/10.1016/j.jcin.2019.07.027;
17. Sapien - Retrospective Analysis: A. Theron “Patient-prosthesis mismatch in new generation trans-catheter heart valves: a propensity score analysis” - Eur Heart J Cardiovasc Imaging - 2018 Feb 1;19(2):225-233. doi: 10.1093/ehjci/jex019;
18. Sapien 3 - Propensity Matched : V. Mauri “Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison” – Circ Cardiovasc Interv. 2017 Oct;10(10):e005013. doi: 10.1161/CIRCINTERVENTIONS.117.005013;
19. Acurate neo™ - Propensity Matched : V. Mauri “Short-Term Outcome and Hemodynamic Performance of Next-Generation Self-Expanding Versus Balloon-Expandable Transcatheter Aortic Valves in Patients With Small Aortic Annulus: A Multicenter Propensity-Matched Comparison” – Circ Cardiovasc Interv. 2017 Oct;10(10):e005013. doi: 10.1161/CIRCINTERVENTIONS.117.005013.
20. Data on file;
21. 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;
22. Data on file;
23. Hatoum et al, Comparison of self and balloon-expanding turbulence pressure recovery, JTCVS 2022;
24. Schäfer, Acute outcomes of a novel self-expanding transcatheter heart valve, Presented at DGK 2018;
25. Moreno et al, Transcatheter aortic valve implantation for degenerated aortic valves: Experience with a new supra-annular device. The Spanish Allegra valve-in-valve (SAVIV) registry, CCI, 2021;
26. Dvir et al, VIVID Registry: Transcatheter Aortic Valve Implantation in Failed Bioprosthetic Surgical Valves, JAMA, 2014;
27. D. Tchétché et al, VIVA: Transcatheter Aortic Valve Replacement for Failed Surgical Aortic Bioprosthesis Using a Self-Expanding Device: One Year Results From the Prospective VIV post-Market Study, JACC, 2019;
28. Dvir et al, CV VIV Indication: Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves Results From the Global Valve-in-Valve Registry, Circulation, 2012;
29. Deeb et al, CV US Study: 1-Year Results in Patients Undergoing Transcatheter Aortic Valve Replacement With Failed Surgical Bioprostheses, JACC, 2017;
30. Webb et al, Partner 2 VIV Registry: Transcatheter aortic valve implantation within degenerated aortic surgical bioprostheses: Partner 2 valve-in-valve registry, JACC, 2017;
31. Cabau et al, Balloon- versus self-expanding valve systems for treating small failed surgical aortic bioprostheses: the LYTEN trial, J Am Coll Cardiol, 2022;

ALLEGRA and IMPERIA are trademarks or registered trademarks of NVT AG, the holding company of NVT GmbH. ALLEGRA™ Transcatheter Heart Valve and IMPERIA™ Delivery System are CE approved medical devices (CE 0124). Third party brands are trademarks of their respective intellectual property right owners. CAUTION: The law restricts these devices to sale by or on the order of a physician and 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. The legal manufacturer of ALLEGRA™ and IMPERIA™ is NVT GmbH, which is part of Blue Sail Medical Co., Ltd. NVT AG and Biosensors International Group, Ltd. and its affiliates are collaborating for the commercialization of the ALLEGRA™ and IMPERIA™ medical devices. Legal manufacturer: NVT GmbH Lotzenäcker 72379 Hechingen Germany. © 2025 NVT GmbH. All rights reserved. NT-DB-120101-EN-02_2025-02.

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, RISE™ NC and RISE™ SC and BioMC™, 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, Rise NC, Rise SC and BioMC 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.