FDA cleared, non-invasive prescription therapeutic device for NVP now available

Dec 9 2009

PrimaBella™, the only non-invasive prescription therapeutic device cleared by the U.S. Food and Drug Administration (FDA) for the treatment of nausea and vomiting due to pregnancy (NVP), is now available. Providing a non-invasive, drug-free treatment for morning sickness, PrimaBella™ has been proven to be safe for both mother and developing baby and can offer quick relief -- the majority of patients report an immediate improvement in NVP symptoms.

PrimaBella™ is a Class II neuromodulation device worn on the wrist, helping pregnant women experience relief from morning sickness without the concern of negative side effects from drugs, such as sedation.

“PrimaBella™ gives patients peace of mind while providing relief from potentially debilitating nausea and vomiting during pregnancy,” said Mike Hulse, MD, an OB/GYN and Chief of Staff at Northside Hospital Cherokee, in Atlanta, Georgia. “PrimaBella provides physicians like me with an effective treatment for managing NVP patients. PrimaBella’s adjustable features helps patients feel in control of their symptoms.”

Nausea may be a result of a dysrhythmic output of the central nervous system, resulting in an erratic stomach rhythm. When activated, PrimaBella™ emits gentle pulses through the median nerve on the underside of the wrist, which travel to the nausea center in the brain. These gentle pulses regulate the nausea signaling process between the brain and stomach (via the vagus nerve), restoring normal stomach rhythm and providing relief of nausea and vomiting.

PrimaBella™ is reimbursable by most insurance plans. For more information, visit www.PrimaBellaRx.com.