The US Food and Drug Administration (FDA) has granted 510(k) clearance to Medtronic‘s temporary lung system, designed for use during open-heart surgical procedures that require a bloodless and motionless surgical field.
The CE-marked Affinity Fusion oxygenation system includes a proprietary fibre winding process with an interlaced pattern that filters the blood to remove carbon dioxide and air bubbles, as well as add oxygen.
Smooth tubular pathways and a curved venous inlet tube embedded in the device reduce blood turbulence during the surgical procedure, according to the US-based medical technology company.
A new oxygenator system holder within the device also provides perfusionists with improved flexibility and ease of use in various operating rooms, including those with limited space.
The device was used during an open-heart surgery at US-based Cleveland Clinic in which a patient underwent a right mini-thoracotomy and mitral valve repair procedure.
It was also used in mitral valve repair cases at the Heart Hospital Baylor Plano in Texas, US.
Medtronic structural heart division senior vice president, president and cardiac surgeon Dr John Liddicoat said the device provides patients undergoing cardiac surgery with an oxygenation system that proactively manages air and gently handles blood.
"This is an important consideration for hospitals that are focused on implementing patient blood management programmes and other initiatives that can impact costs associated with transfusions and post-operative complications," Liddicoat said.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha’Eri.