A Prospective, Single-Arm, Multi-Center Study of the Metavention Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects
The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.
• Age ≥22 and ≤70 years old
• Type 2 diabetes diagnosis meeting the following criteria:
‣ HbA1c \> 7.0% and ≤ 9.0% (53 mmol/mol - 75 mmol/mol), AND
⁃ On at least two anti-diabetic medications; one at the highest tolerated dose with no changes in medication dose in the 12 weeks prior to the first screening visit
• Waist circumference ≥102 cm (male) and ≥88cm (female)
• Diagnosis of hypertension: SBP ≥140mmHg OR SBP ≥130mmHg on hypertension medication(s)
• Documented status of stable lifestyle modifications
• Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study