The post-market study of St. Jude Medical’s EnligHTN renal denervation catheter for the treatment of uncontrolled hypertension has begun, the company announced Jan. 30. The EnligHTN II study is planned for 500 patients at 40 sites in Australia and Europe and will measure the average reduction in patients’ systolic blood pressure six months after undergoing ablation of their renal nerves to reduce otherwise uncontrolled hypertension. The study will focus specifically on how renal denervation with EnligHTN affects sub-groups with varying degrees of kidney function.
The multi-electrode ablation device earned a CE mark in May 2012 based on results of the EnligHTN I trial showing an average reduction in systolic blood pressure of 28 mmHG...
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