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HeRO Graft bypasses central venous stenosis

HeRO Graft bypasses central venous stenosis

HeRO Graft bypasses central venous stenosis

Product catalog summary
Overview: The document discusses the HeRO (Hemodialysis Reliable Outflow) Graft, a medical device designed to reduce catheter dependency in hemodialysis patients, particularly those with central venous stenosis. It highlights the cost benefits, clinical outcomes, and procedural details of the HeRO Graft.
Cost Benefits:
  • The HeRO Graft offers a 23% average annual savings compared to catheters, with over $3,100 saved per patient per year for dialysis centers.
  • It reduces catheter-related infections and hospital admissions, potentially saving $23k to $56k per hospital stay.
  • Interventions and associated costs are lowered by more than 50% compared to catheters.
Clinical Benefits:
  • Infection rates are reduced by 69% compared to catheters.
  • Dialysis adequacy improves by 16% to 32%, with a Kt/V of 1.7.
  • High patency rates are observed, with up to 87% cumulative patency at 2 years.
Device Specifications:
  • The HeRO Graft consists of a Venous Outflow Component and an Arterial Graft Component, connected via a titanium connector.
  • The device is kink-resistant, with a silicone-coated nitinol component that is removable and replaceable.
Procedure Overview:
  • The Venous Outflow Component is placed in the central vein using percutaneous endovascular techniques.
  • The Arterial Graft Component is connected at the deltopectoral groove, with a standard arterial anastomosis performed.
Clinical Outcomes:
  • Bacteremia rates and dialysis adequacy are significantly improved with the HeRO Graft.
  • Cumulative patency and intervention rates are favorable compared to traditional catheters.
Candidate Identification:
  • Patients who are catheter-dependent, have failing AVF or AVG, or exhibit symptoms like swollen arms or distended veins should be considered for the HeRO Graft.
Conclusion: The HeRO Graft provides a reliable, cost-effective, and clinically superior alternative to catheters for hemodialysis patients, particularly those with central venous stenosis.
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Catalog excerpts

HeRO Graft bypasses central venous stenosis-1

Identifying a HeRO Graft Candidate • Is the patient currently catheterdependent or approaching catheter dependency? • Is the measured Kt/V less than 1.4? • Has the flow rate dropped >20%? • Does the patient have swollen arms and/or distended collateral veins? HeRO Graft bypasses central venous stenosis A patient who has central venous stenosis and collateral veins that are distended. Impact of HeRO Graft in the Era of Dialysis Provider Bundling9 If x YES is checked for any box above, consider referring patient for a central bilateral venogram for assessment of central venous stenosis. Cost Benefits • 23% average savings per year with the HeRO Graft compared with catheters 3 • Cost savings of over $3,100 (per patient/year) to the dialysis center when converting catheter-dependent patients to the HeRO Graft 9 • Reduces catheter-related infections and hospital admissions projected at $23k to $56k per stay 10,11 • Lowers interventions and associated costs by more than 50% compared to catheters1,2 0 Missed dialysis sessions Outpatient IV antibiotic use and blood cultures Total Savings Venous Outflow Component Arterial Graft Component Product Code 1) Katzman et al., J Vasc Surg 2009. 2) Gage et al., EJVES 2012. 3) Dageforde et al., JSR 2012. 4) Nassar et al., Semin Dial 2014. 5) Data on file. 6) Hajjar et al., Nephrologie 2004. 7) Dhingra et al., Kidney Int 2001. 8) 2006 NKF KDOQI, Guideline 4. 9) Yost and Dinwiddie, American Society of Nephrology (ASN), Nov 2010. 10) Ramanathan et al., Infect Control Hosp Epidemiol 2007. 11) O’Grady et al., The Centers for Disease Control 2002. Surgical technique is at the discretion of the surgeon. Variations in technique and practices will inevitably and appropriately occur when clinicians take into account the needs of the individual patients, available resources, and limitations unique to an institution or type of practice. HeRO Graft is classified by the FDA as a vascular graft prosthesis. Learn more at www.herograft.com Order at: 888.427.9654 1655 Roberts Boulevard, NW • Kennesaw, Georgia 30144 • USA • Tel: 770 419 3355 • 800 438 8285 • Fax: 770 590 3753 All trademarks are owned by CryoLife, Inc. © 2015 CryoLife, Inc. All rights reserved. Reducing Catheter Dependency

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HeRO Graft bypasses central venous stenosis-2

HeRO Graft HeRO Graft Candidates Procedure Overview HeRO (Hemodialysis Reliable Outflow) Graft is the ONLY fully subcutaneous AV access solution clinically proven to maintain long-term access for hemodialysis patients with central venous stenosis. • Catheter-dependent or approaching catheter dependency Venous Outflow Component: Utilizing percutaneous endovascular techniques, the Venous Outflow Component is placed in the central vein with the radiopaque distal tip in the mid to upper right atrium. • Failing fistulas or grafts due to central venous stenosis Treatment Algorithm Arterial Graft Component:...

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