Medical device giant Boston Scientific (NYSE:BSX) this week touted its newly acquired Vessix Vascular renal denervation system, releasing interim reports from the REDUCE-HTN clinical trial during the Transcatheter Cardiovascular Therapeutics conference in San Francisco.
The results from the 139 patients, of 146 enrolled in the post-market study, show that 85% experienced clinically meaningful reductions in blood pressure and that the device has a "strong safety profile," according to the company.
The new report reinforced interim results released in May during the EuroPCR conference, which featured data from the 1st 41 patients enrolled in the REDUCE-HTN trial.
Boston Scientific’s Vessix system, which it acquired in last year’s $425 million buyout, differentiates itself from rival systems with a bipolar radiofrequency energy approach, which allows the device to denervate the renal nerves associated with hypertension with just about 30 seconds of energy at low doses of about 1 Watt and without the need for cooling, according to study presenter Dr. Ajay Kirtane of New York Presbyterian Hospital and Columbia University Medical Center, who delivered the results during this week’s TCT conference.
Between the REDUCE-HTN clinical series and the RELIEVE studies, researchers hope to enroll more than 1,200 patients for treatment with Vessix renal denervation, evaluating the technology in patients with end-stage renal disease, heart failure, atrial fibrillation and diabetes.
Boston Scientific has already completed enrollment for its REDUCE-HTN first-in-man and post-market studies, which are both amid 1-year follow-up. Boston Scientific hopes before the end of this year to begin enrollment in a global pivotal study, regional regulatory approval studies and a European post-market trial, Dr. Kirtane reported.
Vessix has regulatory approval in the European Union and in the U.K. and is already on the shelves in Europe, the Middle East, Australia, New Zealand and select markets in Asia, according to a company statement.
Renal denervation technologies, once a darling of medical device conferences and industry headlines, have lost some of their shine over the last year as the market proved less lively than previously expected. Some of the reports issued during this year’s TCT meeting may help rejuvenate interest in the technology, which researchers have suggested may have applications in ailments ranging from chronic kidney disease to diabetes and obstructive sleep apnea.
