HEMASHIELD PLATINUM Woven Double Velour Vascular Grafts
The most used, most studied vascular products available in the market.
HEMASHIELD PLATINUM Woven Double Velour Grafts are collagen-impregnated and come in straight, one-branch, or multi-branch graft configurations for aortic repair.
Trusted for more than 20 years, HEMASHIELD grafts are the most used, most studied vascular products available in the market today. More than 2 million HEMASHIELD grafts have been implanted worldwide, demonstrating clinical
efficacy and improved outcomes. These grafts have superior healing, improved tissue ingrowth, higher patency, excellent biocompatibility, and proven efficacy.
HEMASHIELD PLATINUM Branch Grafts: A Graft Designed for Each Technique
In addition to straight and bifurcated options, the following products with presewn branches offer versatility and convenience for a wide variety of aortic repair techniques and procedures.
Four-Branch Graft: Observed clinical advantages of the four-branch arch graft replacement include
- Dramatically reduced cerebral circulatory arrest times1,2,3
- Significantly lowered risk of mortality and risk of neurologic dysfunction2
- Negated the need for direct cannulation of brachiocephalic arteries, which reduces the risk of embolization of air or atherosclerotic debris1,2
- Provides an alternative technique to the Island Technique with retrograde
perfusion via femorals
Angled Four-Branch Graft
- This four-branch graft Includes one branch for perfusion and three angled branches (60 degrees) for repair or replacement of the head vessels
- Angled design mimics the natural anatomy of the head vessels
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 one-branch graft)
- Island Technique for arch repair
Thoraco-Abdominal Aortic Aneurysm (TAAA) Graft
- Designed for repair or replacement of the thoracic and abdominal portions of the aorta
- Applications include replacement of the right and left renal arteries as well as the superior mesenteric artery and celiac arteries
. 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.
. 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.
. 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.
- Woven double velour impregnated polyester graft
- Porosity < 5 mL/min/cm2
Superior Construction and Material
- Advanced construction and double-pass sewing technique provides an
improved anastomotic seal.
- Proprietary collagen impregnation reduces porosity to improve hemostasis.
- Soft, flexible woven material conforms to host vessel for easier anastomosis.
- Provides superb tissue ingrowth and long-term patency.
- Excellent long-term biocompatibility and durability
- Promotes formation of a smooth, thin pseudointima
- Provides controlled resorption for uniform tissue ingrowth
- Soft, flexible woven material designed to conform to host vessel for easy
- Smooth needle passage and excellent suture retention helps reduce bleeding at
- Highly compliant material promotes a snug fit at the anastomosis
- Proprietary collagen-impregnation process promotes optimal healing response
- No pre-clotting required, minimizing suture-hole bleeding
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
CAUTION: Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.
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.
All configurations of the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft are not approved for use as a coronary artery replacement.
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 Grafts 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; aneurysm; psuedoaneurysm. Please be aware that potential adverse effects may arise 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.
Woven grafts should be cut with a low temperature, disposable cautery (e.g., approximately 900 degrees F/approximately 500 degrees C) to prevent raveling. Safety and effectiveness of this product in the extra-anatomic, A-V access, and pulmonary positions, and as a patch have not been established.
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