Prescriptive Information
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 restricts this device to sale by or on the order of a physician.
Indications
The HEARTSTRING™ III 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™ III Proximal Seal System in the portion of the aorta where conventional surgical anastomosis 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™ III Proximal Seal System on patients with aortas less than 2.5cm in diameter.
Warnings and Precautions
- Physicians should be properly trained prior to using the HEARTSTRING™ III Proximal Seal System.
- Physicians should not use the HEARTSTRING™ III Proximal Seal System on portions of the aorta where a partial occlusion clamp cannot be applied, to prevent patient compromise due to hemorrhage.
- The HEARTSTRING™ III 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 anastomosis, ensure that all anastomotic sites are at least 1.5cm apart to ensure hemostasis.
- Do not re-use or resterilize the HEARTSTRING™ III Proximal Seal System or any of its components.
- Do not use the HEARTSTRING™ III Proximal Seal System if the packaging is damaged or opened.
- Inspect the devices to ensure no damage has occurred during transit.
- The Aortic Cutter is a single use (one aortotomy) device. Any attempt to reuse the Aortic Cutter may result in the introduction of air emboli into the aorta.
- The Aortic Cutter is for use on unaltered tissue only. Use on altered tissue (e.g., cardioplegia hole, aortotomy incision) may cause the aortic plug to not be captured by the device and result in the introduction of emboli into the aorta.
