PrimaBella™ - First FDA-Cleared Prescription Device for Non-Invasive, Drug-Free Relief of Morning Sickness - Now Available
Posted Dec 09 2009 12:00am
(BUSINESS WIRE)--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.1
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.
About Nausea and Vomiting Due To Pregnancy (NVP)
NVP affects approximately 70-85% of pregnant women and can range from mild symptoms, with a short duration, to severe symptoms that last throughout the pregnancy2. The most severe form of morning sickness (hyperemesis gravidarum) affects approximately 0.5–2% of pregnant women.2 The precise cause of NVP remains unknown.3 Nausea can occur at any time of the day although it is most common upon waking thus earning the common term, morning sickness4.
PrimaBella™ neuromodulation device is intended for use in the treatment of nausea and vomiting due to pregnancy (NVP). PrimaBella™ technology is licensed by Alaven® Pharmaceutical LLC from Neurowave Medical Technologies™. The device is sold through prescription distribution channels and promoted to obstetricians and gynecologists by Alaven’s professional sales force.
IMPORTANT SAFETY INFORMATION
INDICATION: The PrimaBella™ Neuromodulation device is available by prescription only for the treatment of nausea and vomiting due to pregnancy (NVP).
WARNINGS: PrimaBella™ should only be used on the designated area. Nausea and vomiting may be signs of a serious health problem, seek medical attention if symptoms continue. PrimaBella™ is not a curative and should always be used under medical supervision. Treatment outcomes may vary depending on patient characteristics and any medications a patient may be taking. PrimaBella™ should be kept out of reach of children. Pacemaker users: Use this device only as directed on the wrist to prevent possible interference with your pacemaker. Avoid placing the electrodes of the device directly on your chest or near pacemaker. Consult with your physician if you have other implanted devices. PrimaBella™ should not be used above an IV line attached to a patient’s arm. If a patient is using an IV line, PrimaBella™ should be placed on the opposite arm.
CAUTION: PrimaBella™ contains natural rubber latex, which many cause allergic reactions, and is not recommended for use in conjunction with electrocautery or MRI equipment.
SIDE EFFECTS: Skin irritation can occur beneath or around the electrodes. If irritation occurs, move the device to the other wrist. If irritation does not disappear within 24 hours, stop using the device and consult your doctor or pharmacist. Continued use of the device on irritated skin may cause skin injury.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or other health care professional licensed in the state in which they practice.