What is the approved BMI range for patients to use the TransPyloric Shuttle?

The TransPyloric Shuttle is a medical device used for weight loss and is specifically indicated for use in patients who have a higher baseline body mass index (BMI) that may be associated with obesity-related comorbidities. The approved BMI range of 30 with obesity comorbidity reflects the clinical guidelines which suggest that patients in this category are likely to benefit from therapeutic interventions aimed at weight reduction.

This threshold is significant because obesity-related comorbidities, such as type 2 diabetes, hypertension, and sleep apnea, can lead to serious health complications, and the presence of these conditions elevates the risk profile of the patient. As a result, criteria that include the presence of comorbidities ensure that the device is reserved for individuals who may have a more urgent medical need for weight management solutions since they are at an increased risk of the aforementioned conditions due to their obesity.

This approval status emphasizes a comprehensive approach to obesity treatment, focusing not only on the numeric value of BMI but also on the overall health context of the individual, which is critical in deciding the appropriateness of surgical or device interventions in the management of obesity.