Press Release: “The DIAMOND System for Treating Type 2 Diabetes Found to Have a Desirable Long Term Safety Profile”
- April 18, 2011
The DIAMOND (TANTALUS) System, a minimally invasive gastric stimulation System for Treatment of Type 2 Diabetes developed by MetaCure was found to have a desirable long term safety profile. Safety is a crucial point in Type 2 Diabetes treatments in light of the recent safety concerns regarding some antidiabetic agents and the associated risk and irreversibility of the major surgical approaches aimed to treat Type 2 Diabetes.
Cleveland, OH (PRWEB) April 18, 2011
In a poster presented at the end of March in the Annual Meeting of The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), Prof. Arthur Bohdjalian of the Medical University of Vienna showed that the DIAMOND (formerly TANTALUS) System is well tolerated by patients and adverse event rate drops rapidly and sharply a few weeks after implantation.
Follow up of 138 Type 2 Diabetes patients implanted with the DIAMOND System in the US, Europe and Asia was conducted for up to four years with a mean follow up time of 16 months. A rapid and significant reduction in all types of adverse events was observed over time with the majority of events being resolved within 1 month of implantation. Patients have quickly resumed their normal activity and felt comfortable with the implant. The majority of which were unrelated to the device or procedure. Most procedure related events were consistent with similar laparoscopic events. They were mild to moderate in nature and resolved within 14 days with no sequelae. Device related events were few (9% of events) and were treated by on-site adjustment of stimulation parameters by the company field technicians. A small fraction of them were reported as serious adverse events.
“The DIAMOND System is well tolerated by Type 2 Diabetics” said Prof. Bohdjalian “90% of all patients have demonstrated a sustained improvement in HbA1c and/or weight after 2 years. The System provides a comprehensive metabolic treatment acting as a pivot for patient habit reforming. The DIAMOND System is a safe and effective treatment option for Type 2 Diabetics and is positioned to be the next step in the continuum of care for patients exhausting pharmacological options”
The DIAMOND System is a novel Interventional Diabetology device for treating Diabesity (the combination of Type 2 Diabetes and obesity). It is implanted in a fully reversible minimally invasive procedure with a very short down-time for patients. The DIAMOND System allows patients to maintain an active life style with no dietary or behavioral restrictions and minimal compliance requirements.
About MetaCure – MetaCure is a medical device company dedicated to offering innovative minimally invasive solutions for metabolic and gastric conditions with a focus on Type 2 Diabetes and Obesity. The Company’s leading product, The DIAMOND (TANTALUS) System has been shown to significantly improve glycemic and metabolic control. The DIAMOND (TANTALUS) System is CE approved since 2007 and is commercially available in select excellence centers in Europe.