St. Jude Medical (NYSE:STJ) is aiming to take its renal denervation therapy a step further, looking for signs that the minimally invasive treatment improves health beyond lowering high blood pressure in patients with uncontrolled hypertension.
The company’s new Enlightnment trial is looking for long-term effects of renal denervation therapy, hoping to find out whether it reduces a patient’s risk of major cardiovascular events.
"To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in patients with uncontrolled or resistant hypertension," principal investigator Professor Michael Böhm said in prepared remarks. "What we need to know is if this minimally invasive approach for treating hypertension also correlates to a reduction in major cardiac events such as heart attack, stroke and death, which are the primary risks for patients whose blood pressure is not well controlled."
Uncontrolled high blood pressure causes a patients’ heart to work harder to pump blood throughout the body, putting an estimated 1 in 3 adults around the world at risk of kidney failure, stroke or heart attack, according to the press release.
The growing field of renal denervation therapy is a minimally invasive procedure that uses radiofrequency energy to disrupt the renal nerves near the kidneys.
"Initial study results have demonstrated that the Enlightn renal denervation system is safe and effective in rapidly lowering blood pressure," Professor Thomas Lüscher, also a principal study investigator, said. "If these results extend into the prevention of major cardiac events, there is the potential to dramatically change how we treat these patients."
It’s the 2nd large renal denervation study that St. Jude has announced in recent week. Late last month the company enrolled the 1st patient in a post-market study of its Enlightn renal denervation system, hoping to expand research to patients with less severe forms of hypertension.
St. Jude faces some stiff competition in the renal denervation market, where Medtronic’s (NYSE:MDT) Symplicity system, gained through the January 2011 acquisition of Ardian, already has a head start. Medtronic is also the closest to winning FDA approval for renal denervation, with U.S. clinical trials approved in the summer of 2011.
In May 2012 St. Jude landed CE Mark approval and announced commercial launch for its Enlightn renal denervation system as a treatment for hypertension. St. Jude last year touted study results finding that its Enlightn renal denervation system lowered high blood pressure faster than Medtronic’s Symplicity.