The device has not been cleared for use in the U.S., but Medtronic plans to submit an application to the FDA, according to a press release.
New design features in the Affinity Fusion include a proprietary process that oxygenates and filters the blood while removing particles, novel blood pathways that reduce blood turbulence during procedures and new design features to improve machine handling and ease of use, Medtronic announced.
The device provides patients with temporary lung-function, cleaning and oxygenating blood during procedures such as cardiopulmonary bypass surgery. Medtronic hopes that Affinity Fusion will rapidly gain a foothold, expecting about 1 million patients to need cardiopulmonary bypass surgery this year.
MDT shares saw a mild increase today with a 0.7% bump, trading at $43.64 as of about 1:10 p.m.