Post marketing study of AspireAssist System in obesity published in Obesity Surgery Journal.- Aspire Bariatrics.
Aspire Bariatrics announced the publication of 201-patient, multi-center post-market European registry study of the AspireAssist System for obesity in the peer-reviewed Obesity Surgery Journal. The post market study was designed to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics. The published results demonstrate with statistical significance that aspiration therapy with the AspireAssist System is a safe, effective, and durable weight loss therapy in people with Class II and Class III obesity in a clinical setting.
Significant findings from the trial include: 1) Mean percent total weight loss at 1, 2, 3 and 4 years respectively of 18.2%, 19.8%, 21.3%, and 19.2% 2) Clinically significant reductions in glycated HbA1C, triglycerides and blood pressure 3) For participants with diabetes, an HbA1C decrease of 1% from 7.8% at baseline to 6.8% at one year 4) Results as effective and safe in a community setting as in the research setting, with AspireAssist proving to be a viable, lower cost, alternative therapy to bariatric surgery 5) No statistical difference in efficacy or safety for heavier patients (BMI more than 50kg/m2) vs patients with BMI 35-50 kg/m2; or for older patients (age more than 55) vs patients younger than 55.
See: "Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study." Max Nystr�m et al. OBES SURG (2018). https://doi.org/10.1007/s11695-017-3096-5