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HEARTSTRING® II Proximal Seal System
BOSTON SCIENTIFIC
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3200 Lakeside Drive |
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This hemostatic seal provides an innovative option for CABG anastomoses designed to minimize the release of cerebral emboli associated with the aortic cross-clamp or the side-biting clamp.
Flexibility: Perform proximal anastomoses before or after distal anastomoses.
Versatility: Use arteries or veins for grafts of any size, length, or diameter.
Safety: Designed to avoid embolic release and potential graft kinking with angled take-offs.
HEARTSTRING® II Aortic Cutter
The HEARTSTRING II Aortic Cutter offers state-of-the-art ergonomic design and fully automated cutting action for precision aortotomy in unclamped aortas. It helps assure high-quality results in beating heart clampless anastomoses when used as an integral part of the HEARTSTRING II Proximal Seal System.
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HEARTSTRING II Animation
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Indications, Contraindications, Warnings, and Precautions
Indications: The HEARTSTRING® II Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
Contraindications: Do not use the HEARTSTRING® II Proximal Seal System in portions of the aorta where conventional surgical anastomoses would typically not be created due to the presence of palpable disease. Such determination may also be based upon echocardiograms. Do not use the HEARTSTRING® II Proximal Seal device on patients with aortas less than 2.5 cm in diameter.
Warnings and Precautions: Physicians should be properly trained prior to using the HEARTSTRING® II Proximal Seal System. Physicians should not use the HEARTSTRING® II Proximal Seal on portions of the aorta where a partial occluding clamp cannot be applied, to prevent patient compromise due to hemorrhage. The HEARTSTRING® II Proximal Seal System should not be used in patients with thin-walled aortas due to the potential risk of the tether lacerating the side of the aortotomy. When performing multiple anastomoses, ensure that all anastomotic sites are at least 1.5cm apart to ensure hemostasis. Do not re-use or re-sterilize the HEARTSTRING® II Proximal Seal System or any of its components. The Boston Scientific Aortic Cutter is a single use (one aortotomy) device. Any attempt to reuse the Boston Scientific Aortic Cutter may result in the introduction of air emboli into the aorta.