Tissue valves and conduits

Hancock™ II bioprosthesis

<p>The Hancock<sup>TM</sup> II bioprostheses are for patients who require replacement of their native or prosthetic aortic and/or mitral valves.</p>

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Product details

More than 40 years of delivering consistent performance and results

With Hancock™ II, you can feel confident procedure after procedure.

  • A large, prospective study enrolling 1,134 SAVR patients (mean age of 67) from 1982 to 2004 showed:†,1
    • Freedom from reoperation due to structural valve deterioration (SVD) in the full cohort at 20 years was 68.2%
    • Freedom from SVD at 20 years in patients over the age of 65 was 97.8%
    • The authors conclude: “Hancock™ II bioprosthesis is a very durable valve in patients 60 years and older and is probably the gold standard of bioprosthetic valve durability in this patient population.”
  • A 3-center study including 484 mitral valve replacement patients (mean age 65.8) from 1983 to 2002 with Hancock™ II showed:2
    • 71% Freedom from reoperation at 15 years
    • Freedom from SVD in patients 60 years and older was 88% at 15 years
    • The authors conclude: “Optimal 15-year durability can be expected... in male patients 65 years and older who have undergone mitral valve replacement.”2

Durability 

Published clinical experience demonstrates impressive long-term performance in many SAVR age groups for both the aortic and mitral valve.1–3 Additional factors that may contribute to durability are:

  • T6 (sodium dodecyl sulfate) anti-calcification treatment applied to reduce the absorption of calcium in the leaflets4–6
  • Two-step, low-pressure fixation process

Ease of implant 

Our innovative Cinch™ implant system further capitalizes on the valve’s flexible stent to facilitate valve implantation, particularly through a tight sinotubular space. It also:

  • Improves overall visualization
  • Has stent posts that deflect to allow for easier knot tying near the posts in aortic replacements
  • Helps prevent suture looping
  • Facilitates minimally invasive procedures
  • Protects tissue from inadvertent damage
The innovative Cinch™ implant system further capitalized on the Hancock™ II valve's flexible stent to facilitate valve implantation.

Improved flow 

The Hancock™ II valve is designed to allow the maximum amount of blood to flow through it.7

  • The sewing ring is mounted flush with the inflow edge of the scalloped stent allowing the bioprosthesis to be positioned completely superior to the annulus.
  • The internal diameter of the valve aligns with the patient’s annulus allowing for a larger available flow area.
  • The valve design allows blood to flow through the annulus — encountering only tissue, not obstructive components such as the stent and sewing ring.
See how the Hancock™ II valve is designed to allow the maximum amount of blood to flow through it.

Suitable for future interventions 

Valve dimensions and geometry enable future valve-in-valve (ViV) replacements.

  • Radiopaque annulus ring and stent post markers provide visible, distinct guidelines during ViV procedures.
  • Enabled MR Conditional, with nonmetallic frame that mitigates risk of corrosion between SAV and TAV stent materials.
  • Interior-mounted leaflets mitigate potential risk of coronary obstruction.8

Adverse events potentially associated with the use of bioprosthetic heart valves include: allergic reaction, angina, aortic tissue damage, cardiac dysrhythmias, embolism, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, anticoag/antiplatelet related; inflammatory reaction; infection other than endocarditis; leak, transvalvular or paravalvular; mitral tissue damage; MI; NSVD; pleural effusion; prosthesis regurg; prosthesis stenosis; stroke; SVD; tamponade; valve thrombosis.

Ordering information

Hancock™ II aortic valve, Model T505 

Item
number		 Valve size (stent OD‡) (± 0.5 mm) Orifice diameter (stent ID) (± 0.5 mm) Suture ring diameter (± 1 mm) Valve height (± 0.5 mm) Aortic protrusion (± 0.5 mm)
  (A) (B) (C) (D) (E)
T505C221 21 18.5 27.0 15.0 12.0
T505C223 23 20.5 30.0 16.0 13.5
T505C225 25 22.5 33.0 17.5 15.0
T505C227 27 24.0 36.0 18.5 15.5
T505C229 29 26.0 39.0 20.0 16.0

‡ Equivalent to annulus diameter.
 

Hancock™ II mitral valve, Model T510

Item
number		 Valve size (stent OD‡) (± 0.5 mm) Orifice diameter (stent ID) (± 0.5 mm) Suture ring diameter (± 1 mm) Valve height (± 0.5 mm) Aortic protrusion (± 0.5 mm)
  (A) (B) (C) (D) (E)
T510C25 25 22.5 33.0 18.0 13.5
T510C27 27 24.0 35.0 19.0 14.0
T510C29 29 26.0 38.0 20.5 15.5
T510C31 31 28.0 41.0 22.0 17.0
T510C33 33 30.0 43.0 23.0 17.5

‡ Equivalent to annulus diameter.
 

Hancock II Ultra™ aortic valve, Model T505

Item number Valve size (stent OD‡) (± 0.5 mm) Orifice diameter (stent ID) (± 0.5 mm) Suture ring diameter (± 1 mm) Valve height (± 0.5 mm) Aortic protrusion (± 0.5 mm)
  (A) (B) (C) (D) (E)
T505U221 21 18.5 26.0 15.0 12.0
T505U223 23 20.5 28.0 16.0 13.5
T505U225 25 22.5 30.0 17.5 15.0
T505U227 27 24.0 32.0 18.5 15.5
T505U229 29 26.0 34.0 20.0 16.0

‡ Equivalent to annulus diameter.
 

Hancock™ II bioprosthesis accessories

Item number Description
T7610HKA Tray, accessory, Hancock™ II, aortic
T7605HKM Tray, accessory, Hancock™ II, mitral
T7505UX Tray, accessory, Hancock II Ultra™, supra-X aortic sizer set
7505UX Hancock II Ultra™, supra-X aortic sizer set
7639 Handle (234 mm length) pliant, without locknut handle to be used with Hancock™ II, Hancock II Ultra™ prostheses
7639XL Handle (368 mm length) pliant, without locknut handle to be used with Hancock™ II, Hancock II Ultra™ prostheses
7505SET Hancock™ II aortic obturator set (no handles, no tray)
7510SET Hancock™ II mitral obturator set (no handles, no tray)

† For patients over age 65.

‡ Equivalent to annulus diameter.

  1. David T, Armstrong S, Maganti M. Hancock II bioprosthesis for aortic valve replacement: the gold standard of bioprosthetic valves durability? The Annals of thoracic surgery. 2010;90(3):775–781. doi:10.1016/j.athoracsur.2010.05.034
  2. Rizzoli G, Mirone S, Ius P, et al. Fifteen-year results with the Hancock II valve: A multicenter experience. Journal of Thoracic and Cardiovascular Surgery. 2006;132(3). doi:10.1016/j.jtcvs.2006.05.031
  3. Une D, Ruel M, David T. Twenty-year durability of the aortic Hancock II bioprosthesis in young patients: is it durable enough?. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2014;46(5):825–830. doi:10.1093/ejcts/ezu014
  4. Valfre C, Rizzoli G, Zussa C, et al. Clinical results of Hancock II versus Hancock Standard at long-term follow-up. The Journal of thoracic and cardiovascular surgery. 2006;132(3):595–601, 601.e1-2. doi:10.1016/j.jtcvs.2006.03.062
  5. Butany J, Leong SW, Cunningham KS, D’Cruz G, Carmichael K, Yau TM. A 10-year comparison of explanted Hancock-II and Carpentier-Edwards supraannular bioprostheses. Cardiovasc Pathol. 2007;16(1):4–13.
  6. Rodriguez-Gabella T, Voisine P, Puri R, et al. Aortic bioprosthetic valve durability: incidence, mechanisms, predictors, and management of surgical and transcatheter valve degeneration. Published online 2017. http://www.onlinejacc.org/content/70/8/101
  7. Gallucci V. Cardiac Bioprostheses: Proceedings of the Second International Symposium. Elsevier Science & Technology Books; 1982.
  8. Ribeiro H, Rodes-Cabau J, Blanke P, et al. Incidence, predictors, and clinical outcomes of coronary obstruction following transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: insights from the VIVID registry. European heart journal. 2018;39(8):687–695. doi:10.1093/eurheartj/ehx455