510(k) for Cardio Medical Solution:
This article was originally published in Clinica
Executive Summary
Cardio Medical Solutions has received clearance for its Baladi Inverter, designed as an alternative to clamping during bypass surgery. When inserted in the aortic incision, the device inverts to form a bowl creating a blood-free workspace for surgeons to perform graft attachments to the aorta. The company says the system reduces complications which occur from the compressing forces caused by clamping. The inverter can be used in open-chest surgery under cardiac arrest or in beating heart bypass procedures.