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VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient. This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end. The VIOLA is comprised of: 1. A concentric 4 mm aortic punch with a detachable handle. 2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle. 3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision. The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient. The VIOLA is comprised of: - 1. A concentric 4 mm aortic punch with a detachable handle. - 2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle. - 3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision. The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.