FDA Clears Medtronic’s New Affinity Fusion Oxygenation System For Adult Cardiac Surgery

In short

Medtronic, Inc. has gained U.S. FDA 510(k) clearance of its new Affinity Fusion® oxygenation system. US approval follows CE marking, which was granted last September.

The system is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures.

Newly featured on the system are measures to prevent and remove air bubbles that can enter the blood during the procedure, which may potentially reduce the risk of stroke.


The Fusion oxygenation system is used by perfusionists during open-heart surgical procedures that require a bloodless, motionless surgical field, such as lifesaving cardiopulmonary bypass surgery. As temporary “lungs,” the system adds oxygen and removes carbon dioxide from the blood.

New design enhancements include a proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while at the same time oxygenating the blood.

Smooth tubular pathways for blood to pass through and a first-of-its-kind curved venous inlet tube, both of which can reduce blood turbulence during the surgical procedure;

Enhanced setup and customization capabilities, including a new oxygenator system holder, which Medtronic says gives perfusionists improved flexibility and ease of use in various operating rooms, including those with limited space.

The Fusion oxygenation system was used in the U.S. for the first time at Cleveland Clinic during an open-heart surgery in which a patient underwent a right mini-thoracotomy and mitral valve repair procedure. Additionally, it has been used in mitral valve repair cases at The Heart Hospital Baylor Plano, in Plano, Texas.

Company comments

“The new Affinity Fusion oxygenator is designed to provide perfusionists with the most innovative and enhanced product of its kind,” said cardiac surgeon Dr. John Liddicoat, senior vice president and president of Medtronic’s Structural Heart division. “With so many patients undergoing cardiac surgery each year, Affinity Fusion provides patients with a reliable oxygenation system that is designed to proactively manage air and gently handle blood. This is an important consideration for hospitals that are focused on implementing patient blood management programs and other initiatives that can impact costs associated with transfusions and post-operative complications.”

Source: Medtronic, Inc.