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SURGICAL
VALVE SOLUTIONS
EPIC™ PLUS MITRAL AND AORTIC STENTED TISSUE VALVES

 

The latest generation of the Epic™ Platform continues the Epic product family’s history of excellence. The future-forward design of the Epic Plus mitral and aortic valves gives you and your patients more choices when it comes to preserving long-term treatment paths.

TEN-YEAR FOLLOW-UP OF MITRAL VALVE REPLACEMENT WITH THE EPIC PORCINE VALVE17

At 10 years after implantation, this real-world nationwide study of Medicare beneficiaries receiving the Epic™ Mitral valve demonstrates:

  • 91.4% freedom from all-cause mitral valve reintervention
  • >50% freedom from heart failure rehospitalization

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TISSUE HEART VALVES (THV)

MADE FOR WHAT’S AHEAD

Built on the proven legacy of its predecessors, the Epic™ Plus valve delivers everything you’ve come to expect from the Epic valve—plus significant improvements to radiopacity and implantability to enable future interventions and implantation for even the most challenging patient anatomies.

MITRAL

  • Low stent post height is less likely to obstruct the left ventricular outflow tract (LVOT)1
  • Epic Plus valve leaflets are not prone to forming a curtain between stent posts when opened; curtaining can result in LVOT obstruction


     

AORTIC

  • Can withstand up to approximately 8 atm pressure during balloon valvuloplasty procedures3
  • Internally mounted leaflets and low stent post height reduce coronary obstruction4
  • Increased visibility at valve annulus and stent posts under fluoroscopy for transcatheter aortic valve replacement (TAVR) procedures    

*For 27 mm valve size, measured from the farthest point of the cuff.

Streamlined customizable implantation
  • Stent symmetry eliminates the need for specific orientation3
  •  Flexible polymer stent offers more forgiving insertion and seating
  • Short rinse time of 2 x 10 seconds3
  • Epic™ Platform cuff options allow for secure suture placement while limiting suture drag and parachuting forces
     
Exceptional durability across patient populations

LINX™ ANTICALCIFICATION (AC) TREATMENT MAY IMPROVE LONG-TERM PERFORMANCE AND DURABILITY.*

10 YEARS

97.3 ± 0.5%†
Freedom from surgery for SVD, all patient ages (Epic Aortic Valve)5

95.7 ± 2.6%†
Freedom from surgery for SVD, all patient ages (Epic Mitral Valve)5

98.6 ± 0.8%†
Freedom from surgery for SVD, all patient ages (Epic Aortic & Epic Mitral Valve)5

*There is no clinical data currently available that evaluates the long-term impact of anticalcification tissue treatment in humans.
†From stand-alone aortic or mitral valve replacements.

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THERAPY

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Early outcomes on Epic Max platfrom

Cleveland clinic (US) experience: Early outcomes and a perspective on porcine vs. bovine

EACTS 2024 - Novel approaches for Valvular and LVAD therapies

Reconsidering current approaches to valve and LVAD therapies

Epic™ HCP testimonial

Epic™ Mitral & Supra Aortic stented tissue valves HCP testimonial

Epic™ Mitral Valve

Epic™ Mitral stented tissue valve with Linx™ AC technology

Webinar: Aortic & Mitral Valve Disease

Webinar 2022: Management of aortic and mitral valve disease

EACTS 2022: SMV repair vs replacement

EACTS 2022 Symposium: Surgical Mitral Valve Repair versus Replacement in the Modern Era of Transcatheter Valve Interventions.

References
  1.  Guler N, Ozkara C, Akyol A. Left ventricular outflow tract obstruction after bioprosthetic mitral valve replacement with posterior mitral leaflet preservation. Tex Heart Inst J. 2006;33(3):399-401.
  2. Epic Plus Instructions for Use.
  3. Allen KB, Adnan CK, Cohen DJ, et al. Bioprosthetic valve fracture to facilitate transcatheter valve-in-valve implantation. Ann Thorac Surg. 2017;104:1501-1508.
  4. Edelmann JJ, Khan JM, Rogers T, et al. Valve-in-valve TAVR: state-of-the-art review. Innovations. 2019;14(4):299-310.
  5. Jawad, Khalil, Sven Lehmann, Alex Koziarz, Maja Dieterlen, Stefan Feder, Martin Misfeld, Jens Garbade, Vivek Rao, and Michael Borger. "Midterm results after St Jude Medical Epic porcine xenograft for aortic, mitral, and double valve replacement." Journal of Cardiac Surgery 35, no. 8 (2020): 1769-1777.
  6. Adams DH, Rosenhek R, and Falk V. Degenerative mitral valve regurgitation: best practice revolution. Eur Heart J. 2010;31(16):1958-1967. doi:10.1093/eurheartj/ehq222.
  7. Otto, Catherine M., Rick A. Nishimura, Robert O. Bonow, Blase A. Carabello, John P. Erwin III, Federico Gentile, Hani Jneid et al. "2020 ACC/AHA guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines." Journal of the American College of Cardiology 77, no. 4 (2021): 450-500.
  8. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the management of patients with valvular heart disease. Circulation. 2014;129(23):2240-2492.
  9. Mick SL, Keshavamurthy S, Gillinov AM. Mitral valve repair vs replacement for the management of valvular heart disease. Eur Heart J. 2017;38:2739-2791.
  10. Tests performed by and data on file at Abbott.
  11. Magna Mitral Ease Instructions for Use.
  12. Medtronic Mosaic Bioprosthesis Aortic and Mitral Brochure. #UC200103933b EN.
  13. Vyavahare, N, Hirsch, D, Lerner, E, et al. Prevention of bioprosthetic heart valve calcification by ethanol preincubation. Circulation. 1997:95;479-488. doi.org/10.1161/01.CIR.95.2.479.
  14. Kelly SJ, Ogle MF, Carlyle WC, et al. Biocompatibility and calcification of bioprosthetic heart valves. Presented at: Society for Biomaterials, Sixth World Biomaterials Congress Transaction. May 2000:1353.
  15. Frater RWM, Seifter E, Liao K, et al. Chapter 8. In: Gabbay, S, Wheatley DJ, eds. Advances in Anticalcific and Antidegenerative Treatment of Heart Valve Bioprostheses. 1st ed. Silent Partners, Inc; 1997:105-113.
  16. Vyavahare NR, Hirsch D, Lerner E, et al. Prevention of calcification of glutaraldehyde-crosslinked porcine aortic cusps by ethanol preincubation: mechanistic studies of protein structure and water-biomaterial relationships. J Biomed Mater Res. 1998;40:577-585. doi.org/10.1177/1556984519858020.
  17. Rodriguez E, et al. Ten-year outcomes of a contemporary generation low-profile porcine mitral bioprosthesis in a Medicare population. Poster presented at the STS Annual Meeting; January, 2022; virtual

 

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