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CryoValve® SG

PULMONARY HUMAN HEART VALVE

The Right Valve for
the Right Side.

Product Highlights

  • CryoValve SynerGraft(SG) Pulmonary Human Heart Valve is the first and only decellularized human heart valve to receive 510(k) clearance from the U.S. Food and Drug Administration.
  • The SynerGraft process virtually eliminates the presence of allogeneic donor cells while maintaining the structural integrity of the biological matrix.1,2
  • Excellent durability, optimal hemodynamics, and increased freedom from pulmonary insufficiency.3-5

Product Overview

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1. SYNERGRAFT DECELLULARIZATION PROCESS

The SynerGraft process includes hypotonic cell lysis, enzymatic digestion of nucleic acids, and sequential washing in a neutral buffer. These three steps work together to ensure maximal degradation and removal of donor cell material and nucleic acids without damaging structural proteins.1-3

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Clinical Evidence

Superior Freedom from Conduit Reintervention and Dysfunction

CryoValve® SynerGraft (SG) Pulmonary Valve allografts demonstrate superior Freedom from Reintervention and Dysfunction compared to standard cryopreserved pulmonary allografts, determined by a multi-institutional retrospective review at 10 years:1

  • At 10 years, SG patients demonstrated significantly superior freedom from reintervention at a rate of ~87% compared to SCA patients at ~53%.1

Click here to review additional Clinical Evidence for the CryoValve SG Pulmonary Valve.

 

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Additional Resources

Explore additional resources for CryoValve SynerGraft(SG) below. For further information or to contact a sales associate in your area, contact us.

Ordering Information

Allograft MRI Information Letter

Ross Procedure Clinical Summary

Patient Information Site

Product Highlights

  1. Elkins R, et. al. (2001). Decellularized human valve allografts. Ann Thorac Surg, 71(5), S428-32.
  2. Gerson C, et. al. (2012). Structural integrity of collagen and elastin in SynerGraft decellularized-cryopreserved human heart valves. Cryobiology, 64(1), 33-42.
  3. Ruzmetov M, et. al. (2012). Decellularized versus standard cryopreserved valve allografts for right ventricular outflow tract reconstruction: A single-institution comparison. J Thorac Cardiovasc Surg, 143(3), 543-9.
  4. Brown JW, et. al. (2010). Performance of the CryoValve SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years. J Thorac Cardiovasc Surg, 139(2), 339-48.
  5. Bibevski S, et. al. (2017). Performance of SynerGraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results From Multi-institutional Data. Ann Thorac Surg, 103(3), 869-75.

 

Product Design Features

  1. Elkins R, et. al. (2001). Decellularized human valve ollogrofts. Ann Thoroc Surg, 71(5), S428-32.
  2. Gerson C, et. al. (2012). Structural integrity of collagen and elastin in SynerGraft decellularized-cryopreserved human heart valves. Cryobiology, 64(1), 33-42.
  3. Artivion, Inc. Data on File.

Clinical Evidence

  1. Bibevski S, et. al. (2017). Performance of SynerGraft Decellularized Pulmonary Allografts Compared With Standard Cryopreserved Allografts: Results From Multi-institutional Data. Ann Thorac Surg, 103(3), 869-75.

 

All products and indications are not available/approved in all markets. All trademarks are owned by Artivion, Inc. or its subsidiaries. On-X Life Technologies, Inc., Jotec GmbH, and Ascyrus Medical GmbH are wholly owned subsidiaries of Artivion, Inc. MLENG1594.000. (2023-04)

Artivion, Inc., 1655 Roberts Blvd NW, Kennesaw, GA 30144, US