IntraPace, Inc. announced today that it has received CE Mark for the LGL102, a new gastric stimulation/food sensing lead designed to work with the innovative abiliti(R) implantable weight loss management system. The abiliti system itself was CE marked in early 2011 and this new lead further simplifies its implantation, significantly reducing procedure time. In a recent clinical study of the new lead, procedures were consistently completed in under an hour, and operating time was reduced by 22 minutes, or 30%.
“With the new lead, the implantation procedure is further streamlined resulting in a significant reduction in implantation time. Consequently, the patient spends less time in the operating room,” noted Prof. Thomas Horbach, Chief of Surgery, Stadtkrankenhaus Schwabach, the principal investigator in the LGL102 clinical study in Germany. “Reduced time in the operating room means less risk for the patient and lower overall hospital costs.”
The LGL102 lead simplifies the attachment of the food sensor and stimulation electrodes to the stomach. Once attached, the sensor is able to detect food and drink, triggering the abiliti stimulator device that creates a feeling of fullness in the patient. These eating events, along with episodes of physical activity, are automatically recorded and available for downloading to a personal computer using the connect.abiliti Wand. At the user’s discretion, this data may also be shared on my.abiliti.com, a lifestyle management portal and support network used by abiliti peers, friends and family, and healthcare professionals.
About the abiliti System
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 and intestines is not changed, clinical experience with the abiliti system has shown virtually none of the nausea, diarrhea 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 behaviors and develop effective strategies for maintained weight loss. Additionally, the system connects patients to a valuable social support network (my.abiliti.com), which research has demonstrated can increase the effectiveness of weight loss programs.
IntraPace was founded in 2001 to address an unmet need in weight loss surgery by developing a gentler solution for weight loss that incorporates essential components of behavior therapy. The abiliti system enables patients to achieve and sustain significant weight loss without the complications, lifestyle restrictions and substantial anatomical changes associated with the established weight loss surgeries.
Based in Mountain View, California, IntraPace is backed by premier investors, including Boston Scientific, CB Health Ventures, DFJ ePlanet Ventures, InCube Ventures, Johnson & Johnson Development Corp., L Capital Partners, Oxford Bioscience Partners, Toucan Capital Corp, Angels’ Forum, Halo Fund and Vulcan Capital.
The abiliti system has CE Mark in the European Union. It is not approved for sale in the United States.
Source: IntraPace, Inc