On 26 April 2012,Edwards Lifesciences announced the global launch of the ThruPort IntraClude intra-aortic occlusion device for use in patients undergoing cardiopulmonary bypass, including during mitral heart valve repair or replacement surgery using a minimally invasive approach. Edwards has CE mark approval for European sales of the device and 510(k) clearance from the FDA.
“The IntraClude device is able to be introduced peripherally, enabling surgeons to access the mitral valve through the smallest incision possible,” said Borut Gersak, Department of Cardiovascular Surgery, University Medical Center Ljublijana, Slovenia. “The advanced features facilitate ease of positioning and minimal migration of the device during the procedure, which allows the surgeon to focus on the repair or replacement of the valve and deliver to the patient the benefits of minimal-incision surgery.”
The IntraClude is the only device of its kind for use in minimal-incision valve surgery. It features a 9F shaft that is delivered via the femoral artery and occludes the ascending aorta, enabling the use of fewer products within the principal incision site to maximise visualisation of the surgical field and cardiac structures.
The device provides for multiple functions in a single device, delivering antegrade cardioplegia solution to stop the heart and protect it during surgery, venting the aortic root to facilitate a bloodless surgical field and monitoring aortic root pressure to verify the occlusion of the ascending aorta throughout the surgery. IntraClude also maximizes perfusion flow rates to provide low perfusion pressures and protect the patient while on cardiopulmonary bypass.