Medical device maker St. Jude Medical announced in a press statement Wednesday that it has enrolled the first patient in a clinical trial of its EnligHTN renal denervation device. The study, dubbed the EnligHTN II trial, will judge the safety and efficacy of St. Jude's product in patients with uncontrolled hypertension.
The EnligHTN is currently cleared by regulators overseas in treating drug-resistant hypertension, but this latest trial will build on that by enrolling up to 500 patients at 40 sites across Europe and Australia. The EnligHTN II trial also hopes to back the blood pressure-lowering results of the EnligHTN I trial, an earlier hypertension study from St. Jude.
Dr. Johannes Brachmann expanded upon renal denervation in the company press release, saying, "There is convincing evidence from studies like the EnligHTN I trial linking renal denervation to improved blood pressure in patients who have drug-resistant hypertension...Expanding this research to patients with less severe forms of hypertension is important as this minimally invasive approach allows for a shorter procedure time and a potentially faster recovery time, which may benefit more patients with uncontrolled hypertension."
According to the release, data from the World Health Organization shows that one in three adults around the globe have higher-than-normal blood pressure.
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