HEMASHIELD Four Branch Graft   HEMASHIELD Three Branch Graft
     
HEMASHIELD PLATINUM FOUR BRANCH GRAFT   HEMASHIELD GOLD THREE BRANCH GRAFT
Observed clinical advantages of the four branch arch graft replacement include:
Dramatically reduced cerebral circulatory arrest times
(8.8 minutes compared to other similar procedures which
averaged 35 minutes)1,3-4
Significantly lowered risk of mortality and risk of neurologic
dysfunction3
Negated the need for direct cannulation of brachiocephalic
arteries, which reduces the risk of embolization of air or
atherosclerotic debris1,3
Provides an alternative technique to the Island Technique
with retrograde perfusion via femorals
  Observed clinical advantages aortic arch replacement using Hypothermic Circulatory Arrest (HCA) with Selective Cerebral Perfusion (SCP) using a 3 branch graft:
Clinical study showed superior results compared to HCA
alone for preventing embolic risk during operations on the
aortic arch1
Reduced the amount of time and the associated
complications of cardiopulmonary bypass and/or selective
cerebral perfusion1
Provided better clinical outcomes in clinical studies1 and is
an alternative to the Island Technique
Intended to provide superior operative support by allowing
precise construction of the Elephant Trunk anastomosis
 
 
 
 
HEMASHIELD Straight Graft   HEMASHIELD One Branch Graft
     
HEMASHIELD PLATINUM STRAIGHT GRAFT   HEMASHIELD PLATINUM ONE BRANCH GRAFT
     
The straight and one branch grafts may be used for various procedures including:
• Ascending Thoracic Aortic Repair
• Descending Thoracic Aortic Repair
• Ascending and Innominate Repair (with single branch
  graft)
• Island Technique for Arch Repair
  Clinical advantages of the one branch graft:
• Designed to allow easier connection to the bypass
  machine2
• Helps to keep the bypass cannula out of the operating
  field2
• May reduce time required for circulatory arrest since the
  graft is preassembled
• Helps preserve aortic graft integrity by providing cannula
  support for bypass instead of puncturing the arch graft   with the cannula
 
 
 
HEMASHIELD PLATINUM Grafts – the most used, most studied vascular grafts.
Whether the procedure requires a straight, one branch or multi-branch graft, HEMASHIELD PLATINUM is the name that means history, hemostasis, handling and healing.

• Over 45 years textile graft technology experience
• Over 8 million implanted textile grafts
• Over 2 million HEMASHIELD implants
 
Clinical Benefits include:
• Reduced procedure time1
• Improved cerebral protection and hemostasis1-3
• More technique options
 
Patient Benefits include:
• Improved outcomes1-2
• Significantly reduced complications1
• Shortened intensive care and hospital stay1
 
Advanced Hemostasis:
• Proprietary collagen impregnation reduces porosity to   improve hemostasis
• Double-pass sewing technique provides improved   anastomotic seal
 
Advanced Handling4:
• Soft, flexible woven material conforms to host vessel for   ease of anastomosis
• Ease of suturing, smooth needle passage, snug
  anastomosis
 
Advanced Healing:
• Superb tissue ingrowth and long-term patency in
  pre-clinical studies5
• Excellent resorption rates facilitate superior, uninterrupted   healing5
• Excellent long-term durability6
 
INSTRUCTIONS FOR USE

PRESCRIPTIVE INFORMATION: Refer to the operator’s manual for complete instructions for use.

INDICATIONS: All configurations of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

CONTRAINDICATIONS: All configurations of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft are not approved for use as a coronary artery replacement.

WARNINGS: DO NOT PRECLOT. With the treatment of HEMASHIELD PLATINUM grafts, no preclotting is required. STERILE, DO NOT RESTERILIZE, SINGLE USE ONLY. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft cannot be resterilized. This graft should not be implanted in patients with a known sensitivity to products of bovine origin.

POTENTIAL ADVERSE EFFECTS: Bleeding, Thrombosis, Embolism, Graft infection even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

CAUTIONS: Woven grafts should be cut with a low temperature, disposable cautery (e.g., approximately 900 degrees F/approximately 500 degrees C) to prevent raveling. The safety and effectiveness of this product in the extra-anatomic, A-V access and pulmonary positions, and as a patch, have not been established.
 
The information provided in this brochure is not intended to constitute medical advice. Please reference entire paper for further information.

1. Strauch JT, Spielvogel D, Lauten A, Galla J, Lansman S, McMurtry K, Griepp R. Technical advances in total aortic arch replacement. Ann Thorac Surg. 2004;77:581-590.
2. Spielvogel D, Lansman SL, Griepp RB. Aortic Arch Replacement/Selective Antegrade Perfusion. Operative Techniques in Thoracic and Cardiovascular Surgery: A Comparative Atlas. 2005;10(1):23-44.
3. Kouchoukos NT, Masetti P. Total aortic arch replacement with a branched graft and limited circulatory arrest of the brain. J Thorac Cardiovasc Surg. 2004;128:232-237.
4. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. J Thorac Cardiovasc Surg. 1993;106(3):427-433.
5. Hirt SW, Aoki M, Demertzis S, Siclari F, Haverich A, Borst HG. Comparative in vivo study on the healing qualities of four different resealed vascular prostheses. J Vasc Surg. 1993;17(3):538-545.
6. Hallett J, Marshall DM, Petterson TM, Gray DT, Bower TC, Cherry KJ, et al. Graft-related complications after abdominal aortic aneurysm repair: reassurance from a 36-year population-based experience. J Vasc Surg. 1997;25:277-286.
 
 
 
STRAIGHT TUBES
UPN Order
Number
Diameter
(mm x mm)
Usable Length
(cm)
Over 15cm Usable Length
M00202175112P0 175112P 12 15
M00202175114P0 175114P 14 15
M00202175116P0 175116P 16 15
M00202175118P0 175118P 18 15
M00202175120P0 175120P 20 15
M00202175122P0 175122P 22 15
M00202175124P0 175124P 24 15
M00202175126P0 175126P 26 15
M00202175128P0 175128P 28 15
M00202175130P0 175130P 30 15
M00202175132P0 175132P 32 15
M00202175134P0 175134P 34 15
M00202175138P0 175138P 38 15
Over 30cm Usable Length
M00202175206P0 175206P 6 30
M00202175207P0 175207P 7 30
M00202175208P0 175208P 8 30
M00202175210P0 175210P 10 30
M00202175412P0 175412P 12 30
M00202175414P0 175414P 14 30
M00202175416P0 175416P 16 30
M00202175418P0 175418P 18 30
M00202175420P0 175420P 20 30
M00202175422P0 175422P 22 30
M00202175424P0 175424P 24 30
M00202175426P0 175426P 26 30
M00202175428P0 175428P 28 30
M00202175430P0 175430P 30 30
M00202175432P0 175432P 32 30
M00202175434P0 175434P 34 30
M00202175438P0 175438P 38 30
Over 40cm Usable Length
M00202175306P0 175306P 6 40
M00202175307P0 175307P 7 40
M00202175308P0 175308P 8 40
M00202175310P0 175310P 10 40
Over 60cm Usable Length
M00202175406P0 175406P 6 60
M00202175407P0 175407P 7 60
M00202175408P0 175408P 8 60
M00202175410P0 175410P 10 60
M00202175620P0 175620P 20 60
M00202175622P0 175622P 22 60
M00202175624P0 175624P 24 60
M00202175626P0 175626P 26 60
M00202175628P0 175628P 28 60
M00202175630P0 175630P 30 60
M00202175632P0 175632P 32 60
M00202175634P0 175634P 34 60
M00202175638P0 175638P 38 60
 
The C-code used for this product is C1768, Vascular grafts. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. Medicare mandates certain C-code/CPT® code combinations.
 
BIFURCATIONS
UPN Order
Number
Diameter
(mm x mm)
Usable Length
(cm)
Over 40cm Usable Length
M00202166126P0 166126P 12 x 6 40
M00202166147P0 166147P 14 x 7 40
M00202166148P0 166148P 14 x 8 40
M00202166168P0 166168P 16 x 8 40
M00202166169P0 166169P 16 x 9 40
M00202166189P0 166189P 18 x 9 40
M00202166180P0 166180P 18 x 10 40
M00202166201P0 166201P 20 x 10 40
M00202166211P0 166211P 20 x 11 40
M00202166221P0 166221P 22 x 11 40
M00202166241P0 166241P 24 x 12 40

One Branch Graft

UPN Order
Number
Thoracic Size
(mm x cm)
Branch
Diameters(mm)
M00202175820P0 175820P 20 x 50 10
M00202175822P0 175822P 22 x 50 10
M00202175824P0 175824P 24 x 50 10
M00202175826P0 175826P 26 x 50 10
M00202175828P0 175828P 28 x 50 10
M00202175830P0 175830P 30 x 50 10
M00202175832P0 175832P 32 x 50 10
M00202175834P0 175834P 34 x 50 10
Three Branch Graft
UPN Diameter
(mm)
Usable Length
(cm)
Branch
Diameters (mm)
M002021759120 12 30 8
M002021759140 14 30 10
FOUR BRANCH GRAFT
UPN Order Number Thoracic Size
(mm x cm)
Branch
Diameters (mm)
M00202175920P0 175920P 20 x 50 10, 10, 8, 8
M00202175922P0 175922P 22 x 50 10, 10, 8, 8
M00202175924P0 175924P 24 x 50 10, 10, 8, 8
M00202175926P0 175926P 26 x 50 10, 10, 8, 8
M00202175928P0 175928P 28 x 50 10, 10, 8, 8
M00202175930P0 175930P 30 x 50 10, 10, 8, 8
M00202175732P0 175732P 32 x 50 12, 10, 10, 10
M00202175734P0 175734P 34 x 50 12, 10, 10, 10
Angled Four Branch Graft
M00202175724AP0 175724AP 24 x 50 12, 10, 8, 8
M00202175726AP0 175726AP 26 x 50 12, 10, 8, 8
M00202175728AP0 175728AP 28 x 50 12, 10, 8, 8
M00202175730AP0 175730AP 30 x 50 12, 10, 8, 8
THORACO ABDOMINAL AORTIC ANEURSYM Graft
UPN Diameter
(mm)
Thoracic Size
(mm x cm)
Branch
Diameters (mm)
M00202175426T0 175426T 26 x 47 10, 10, 8, 8
M00202175428T0 175428T 28 x 47 10, 10, 8, 8
M00202175430T0 175430T 30 x 47 10, 10, 8, 8
M00202175432T0 175432T 32 x 47 10, 10, 8, 8