CE Mark For Medtronic’s New Oxygenation System

“Being part of the collaboration process during the Affinity Fusion oxygenation system development, I am confident that this new technology will benefit patients who undergo these lifesaving procedures and the surgical teams that use it.”

In short

Medtronic, Inc. has announced CE Mark for its new Affinity Fusion® oxygenation system, opening the door to a European launch. The system, which oxygenates and removing carbon dioxide from blood during various open-heart surgical procedures, incorporates numerous innovations for claimed patient safety and ease of use.

Background

This year it is estimated that cardiopulmonary bypass will occur in roughly 1 million patients worldwide.

Hardware such as Medtronic’s Affinity Fusion oxygenation system are used by perfusionists during open-heart surgical procedures that require a bloodless, motionless surgical field. The system adds oxygen and removes carbon dioxide from the blood, acting as temporary “lungs” for the duration of the procedure.

Medtronic says its Affinity Fusion oxygenation system features a raft of new design enhancements including 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 and a first-of-its-kind curved venous inlet tube, both reduce blood turbulence as it passes through the device. Prevention, filtering and removal of air bubbles are important measures in avoiding the risk of stroke.

Finally, providing a clue to the fact that the company worked with many perfusionists to develop the product, enhanced setup and customisation capabilities, including a new oxygenator system holder, provide the operator with improved flexibility and ease of use in various operating rooms, including those with limited space.

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 who undergo cardiac surgery each year, Affinity Fusion provides patients with a reliable oxygenation system they can count on.”

Physician comments

“During cardiopulmonary bypass, it is imperative that the equipment is designed to maximize patient safety, yet is also sophisticated, versatile and simple to use,” said Simon Phillips, chief clinical perfusionist at St George’s Hospital in London. “Being part of the collaboration process during the Affinity Fusion oxygenation system development, I am confident that this new technology will benefit patients who undergo these lifesaving procedures and the surgical teams that use it.”

Regulatory status

The Affinity Fusion oxygenator is not available in the United States, but Medtronic plans to submit an application for U.S. clearance. In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

Source: Medtronic, Inc.