HEARTSTRING III Proximal Seal System
An easy-to-use advance in patient care and helps reduce the release of emboli.
The HEARTSTRING Proximal Seal System allows you to achieve clampless hemostasis during CABG proximal anastomoses while suturing with your own hand. It's an easy-to-use advance in patient care and helps reduce the release of emboli that can potentially have post-surgical neurocognitive consequences for patients.
The HEARTSTRING III device provides a simple option for CABG proximal anastomoses. It allows the hand-suturing technique without using either the cross clamp or the side-biting clamp.
Perform proximal and distal anastomoses in any order
Use arteries or veins for grafts of any size, length, or diameter
Allows for takeoffs at any angle
Designed to help reduce aortic manipulation and embolic release
Seal Loader and Delivery Device make HEARTSTRING even easier to use
Clampless Beating Heart Surgery
When a patient is diagnosed with coronary artery disease, a surgeon can perform an operation to restore healthy blood flow to the heart. In this procedure, one or more healthy blood vessels will be taken from the arm, leg or chest and are used to create “new” vessels for the heart. The surgeon will connect or graft one end of the harvested vessel to the aorta that supplies the blood to the heart; the other end will be attached at the surface of the heart, bypassing the blocked portion of the coronary artery. It is not uncommon for a surgeon to perform three or four of these grafts during one operation.
Today many people that have medical conditions such as diabetes, history of stroke, or poor physical health can undergo cardiac surgery with a clampless approach which may lower their risk for developing complications. In contrast to conventional bypass surgery, which stops the heart and puts the patient on a heart-lung machine during the grafting procedure, clampless beating heart bypass surgery uses local stabilization of the heart that allows the surgeon to sew the bypass graft while the heart still beats.
The potential benefits of beating heart surgery may include1:
- Less trauma to the body, since the heart-lung machine is not used
- Fewer cognitive and neurological effects (for example, a stroke)
- Less risk of problems with memory
- Faster recovery rates
- Shorter hospital stays
- Fewer blood transfusions needed
Instructions for Use
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.
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.
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.
 Puskas J, Cheng D, Knight J, et al. Off-pump versus conventional coronary artery bypass grafting. A meta-analysis and consensus statement from the 2004 ISMICS Consensus Conference. Innovations. 2005; 1:3-27