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Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) is a less invasive alternative to conventional coronary artery bypass graft (CABG) surgery. MIDCAB is performed through two to three small incisions (1" - 2" each) between the ribs while the heart is beating. By comparison, a traditional CABG procedure cuts through the sternum using one large incision (6" - 8") and requires the use of a heart-lung machine to divert blood during the procedure while the heart is stopped.
By using two to three small incisions, eliminating the use of the heart-lung machine, and operating on a beating heart, research shows that MIDCAB procedures provide the following patient advantages over conventional CABG surgery:
MIDCAB Procedure |
Traditional CABG Procedure |
- Patients may be discharged in 2-3 days
- Return to normal activities including driving in 2 weeks
- Available to high risk patients when bypassing one to two coronary arteries
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- Patients may be discharged in 5-10 days
- Return to normal activities including driving in 6-8 weeks
- Available to low risk patients; recommended when bypassing three or more arteries
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AesDex's PAS-Port system is a fully automated-device used to perform an anastomosis between a saphenous vein and the aorta during minimally-invasive or conventional, on- or off-pump CABG surgery. The PAS-Port system has been used in Japan and Europe since 2004, and received 510(k) clearance in the United States in 2008.
The PAS-Port system is designed to:
- Eliminate aortic clamping and manipulation. Eliminating clamping may reduce the risk of particle release and ensuing neurocognitive events
- Allow the surgeon to load the bypass graft and rapidly complete the anastomosis, typically in approximately one minute
- Provide one-turn aortotomy and anastomosis
- Reduce time required for anastomosis
- Produce consistent, reproducible anastomoses, largely independent of surgical technique and skill set
- Ensure secure graft attachment allowing for variable take-off angles
- Leave no metal within the graft lumen
- Be loaded into the system without damaging endothelial cells while maximizing the orifice, which is especially
important in small grafts
- Allow mechanically-governed repeatability and reduced procedural complexity
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Pull Through
The bypass vessel graft is pulled through the PAS-Port system in preparation for deployment. |
Eversion
The graft vessel is everted in preparation for deployment. |
Poke Through
The vessel is prepared and ready to attach to the aorta. |
PAS-Port System Met All Endpoints in Pivotal Trial
A 220-patient, prospective, pivotal, randomized trial of the PAS-Port® system was conducted at 12 sites in the United States and Europe. The trial compared venous bypass grafts to the aorta made using the PAS-Port system versus those made using conventional hand-sewn sutures. Results showed that the study met its primary endpoint of non-inferiority to hand-sewn anastomoses, as well as all other primary and secondary endpoints.
The results of the EPIC trial were published in the July 2009 issue of The Journal of Thoracic & Cardiovascular Surgery. To request a copy of the published report, click here.
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The Flex-A system, with its flexible shaft, allows surgeons to perform vessel connections in areas of the heart that are difficult or impossible to reach using hand-sewn anastomoses.
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The C-Port Flex-A system is designed to:
"Works on very small coronary arteries." |
- Improve quality, reliability and consistency of bypass graft connections
- Reduce operating time and cost during MIDCAB procedures
- Allow surgeons to position the device to create a secure connection even in difficult to reach areas of the heart
- Facilitate minimally-invasive, closed-chest CABG surgery
- Create compliant anastomoses in vessels greater than 1.3 millimeters in internal diameter
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A clinical study demonstrated that 95% of the graft vessels studied following an anastomosis with the C-Port device were found to be open in angiograms performed at 6 months postoperatively. To view this study, click here.
For more information about the products, please contact AesDex, LLC.
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