IntraPace, Inc., announced today that it has received European CE Mark approval for the abiliti system as a treatment for obesity. The CE Mark certifies that a product has met European Union requirements for commercial marketing in Europe.
“CE Mark for the abiliti system is a major milestone for IntraPace that enables us to begin our commercialization strategy in Europe. Initially, the abiliti system will be offered through specialist clinics, starting in the UK, Spain, and Germany.”
"While gastric banding, sleeve gastrectomy and gastric bypass are very effective treatments for obesity, they alter the digestive tract and are often associated with significant side effects. These side effects make many potential patients reluctant to choose these procedures," stated Prof. Thomas Horbach, Chief of Surgery, Stadtkrankenhaus Schwabach, a leading obesity clinic in Germany. "Patients receiving the abiliti system achieved substantial weight loss with almost none of the side effects seen with other bariatric interventions. This therapy addresses the biggest limitation of the established bariatric procedures."
The implantable device looks similar to a pacemaker and is built on the same proven technology used in millions of cardiac pacemakers and defibrillators each year. Following implantation via a simple minimally invasive surgical procedure, the abiliti system detects when a person eats or drinks and sends low level electrical impulses to the stomach. This stimulation is intended to help a person feel full before the stomach is actually full, causing them to eat less. As the anatomy of the stomach is not changed, clinical experience with the abiliti system has shown virtually none of the nausea and other side effects seen with gastric bypass surgery and gastric banding. Patients are not restricted in the types of food that they consume, but are encouraged to adopt a healthy diet and exercise program.
Further, this novel system automatically records when a patient eats, drinks, and exercises. Using a simple wireless connection, patients and physicians can view the consumption and exercise data. Access to this important information provides an enormous benefit as it allows physicians and patients to understand patient behaviours and develop effective strategies for weight loss. Additionally, the system connects patients to a valuable social support network, support which research has demonstrated increases the effectiveness of weight loss programs.
"CE Mark for the abiliti system is a major milestone for IntraPace that enables us to begin our commercialization strategy in Europe. Initially, the abiliti system will be offered through specialist clinics, starting in the UK, Spain, and Germany." noted Chuck Brynelsen, President & CEO of IntraPace. "The incidence of obesity among the world's population continues to grow each year, creating a huge demand for effective solutions. The abiliti system provides a patient-friendly solution that we believe many people considering weight loss surgery will find attractive."