Cardiothoracic surgery is one of the only surgical specialties still using wires to close bones, but the days of wire-based sternal closure may be numbered, thanks to an innovative device developed by Cleveland Clinic surgeons.
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In high-risk patients undergoing cardiothoracic surgery, wires may not produce a tight closure or stable union at the sternum, thereby delaying recovery and causing chronic pain or audible clicks.
CT surgery meets orthopaedics
This spurred cardiothoracic surgeons Douglas Johnston, MD, and Edward Soltesz, MD, and orthopaedic surgeon Wael Barsoum, MD, to team with colleagues from Cleveland Clinic’s commercialization arm, Cleveland Clinic Innovations, to develop a rigid sternal closure device that perfectly realigns the bone and eliminates the motion that can occur with wire closure.
The device, called The Grand Pre Sternal Closure System (JACE Medical), received FDA approval in January 2015. Cleveland Clinic is currently using it primarily on patients at high risk for sternal nonunion.
First plate-and-screw device designed for the sternum
The device, which employs plate-and-screw technology that’s standard in orthopaedics, is the first designed specifically for sternal closure. Existing devices occasionally used for this purpose are placed at the end of the operation and often leave a gap between the two halves of the sternum, raising the risk of bleeding. In contrast, The Grand Pre uses a ratchet system to close the space tightly, which promotes healing and helps avoid bleeding.
The preloaded plate is placed on the sternum before surgery and secured with screws in less than a minute. The pre-positioned plates provide a template for sternal incision (image above) that aids in achieving true anatomical alignment during closure.
After surgery, the bones are brought together, a locking element is placed between the two halves of the plate, and the ratchet (first image below) brings the two halves of the sternum together with perfect alignment (second image below).
The Grand Pre can be used in reoperations as well as first-time sternotomies. It is biocompatible and MRI-compatible.
For more on the rationale behind this rigid sternal closure device, see this short video by co-developer Dr. Johnston.