Advanced hemodynamic monitoring platform cleared by FDA

Edwards Lifesciences announced the FDA clearance of its technology to monitor hemodynamics during PCI and other procedures.

The advanced monitoring platform (HemoSphere) collects hemodynamic data, aiding physicians in making timely clinical decisions.

“The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our most complex, critically ill patients,” Davinder Ramsingh, MD, director of clinical research and perioperative ultrasound and associate professor in the department of anesthesiology at Loma Linda University Medical Center, California, said in a press release. “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.”

Using visual clinical support screens and an intuitive touchscreen, the platform can assist clinical teams can adapt the system to meet the needs of their care environment, the company stated in the release.

The system is compatible with the Edwards Swan-Ganz pulmonary artery catheter and Oximetry catheters, according to the release.

The advanced monitor is additionally approved for commercial use in Europe, Japan, Australia and New Zealand.

Disclosure: Ramsingh reports receiving honoraria and consultant fees from Edwards Lifesciences.