FDA clears Edwards’ blood flow monitor


Edwards Lifesciences has earned FDA clearance for its blood flow monitoring platform. CE-marked in January, the device tracks circulation and cardiac function, and helps physicians make treatment decisions.

The HemoSphere monitor is compatible with Edwards’ Swan-Ganz pulmonary artery catheter and Oximetry catheters and allows physicians to assess blood flow to a patient’s tissues and organs.

The platform is scalable, so it may be customized to fit patients’ and clinicians’ needs, the company said in a statement. It is also wireless-enabled.

"The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our most complex, critically ill patients," said Davinder Ramsingh, M.D., an associate professor in the department of anesthesiology at Loma Linda University Medical Center, in the statement. "Clinicians can choose the clinical support screens that best suit their needs and monitor the pressures and blood flow of the right heart as conditions change, informing potentially life-saving decisions on behalf of their patients."

RELATED: Edwards aims to go younger in 2017 with bioprosthetic aortic valve: Study

The structural heart specialist is embroiled in an international patent feud with Boston Scientific—Edwards sued the Massachusetts devicemaker in 2015, charging that Boston Sci had infringed on its patents relating to sealing in transcatheter aortic valve replacements (TAVRs). Most recently, a German court ruled that Boston Sci infringed on one Edwards patent and that Edwards violated two Boston Sci patents.

TAVR suits aren’t new for Edwards—in 2007, the company sued Medtronic, eventually arriving at an agreement in 2014 that Medtronic would hand over a onetime payment of $750 million as well as royalty payments until 2022.