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The ByPass CorLink™ Aortic Anastomotic Device (CorLink™ AAD) is intended to be used in CABG procedures for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit.

This 510(k) notification describes a device intended for use in Coronary Artery Bypass Grafting procedures for creating a rapid sutureless proximal anastomosis between a grafted vessel and the aorta. The C-Punch device is intended for creating the aortotomy in which the implanted device will be deployed. The C-Punch device is equivalent to the Linear Punch already cleared as a component of the CorLink AAD (K011589) with respect to intended use, materials and performance of the aortotomy. The major difference between the two systems is the method by which the punch creates the aortotomy. The Linear Punch creates an aortotomy by insertion of the punch tip to the aortic wall and retraction of the punch tip against the cutting tube. The cut piece of the aortic wall is contained within the cutting tube. The C-Punch achieves the same aortotomy sizes and quality by insertion of a central needle and cutting/coring the tissue by rotating the punch device clockwise and counterclockwise. The cut piece of the aortic wall is contained within the cutting/coring tube.

The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.

The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure. The CorLinkTM AAD, delivered with an introducer kit, is a single use system. The implant is made of self-expanding nitinol and composed of two main elements: the self-expandable center area and the flexible pins at both ends. The center is made of connected elliptic arches, which upon implant expansion exert a radial force on the everted vein end and the aortic wall. The flexible pins from both ends of the device fold and "bite" the aortic wall in a way that connects and compresses the grafted vessel against the aorta. This procedure stabilizes the implant at the desired location and creates a sealing surface around the anastomosis.