Aortic open-surgery heart valve bioprosthesis/synthetic polymer aorta graft

This category includes implantable devices that combine a biological heart valve, typically derived from animal tissue such as porcine or bovine sources, with a synthetic polymer tube designed to replace both the aortic valve and a segment of the ascending aorta. These devices are used during open-heart surgery to treat conditions like aortic valve disease combined with aortic aneurysm, dissection, or enlargement, allowing for simultaneous valve replacement and aortic repair.

Devices in this category are implanted surgically and are intended for single use. They are regulated as active implantable medical devices or implantable prostheses depending on jurisdiction, and their design relies on processed biological tissue and engineered synthetic materials to ensure durability and compatibility with the aortic anatomy.