Prior studies have generally focused on patients with "drug-resistant" hypertension, those with a systolic blood pressure reading above 160 mmHg despite treatment with 3 or more drugs. The new Enlightn II post-market study is eying the "uncontrolled" population, patients with a less severe form of hypertension.
The new trial builds on the success of Enlightn I, in which researchers concluded that treatment with St. Jude’s renal denervation system produced significant and sustained reduction in systolic blood pressure. Patients on average experienced a stable 26 mmHg reduction in blood pressure 6 months after treatment, according to a press release.
"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," principal investigator Dr. Johannes Brachmann said in prepared remarks. "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."
Enlightn II will ultimately enroll about 500 patients at 40 sites in Europe and Australia.
Some tough competition
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.
Fellow medtech giant Boston Scientific’s (NYSE:BSX) also looking to stay apace in the highly competitive renal denervation market, expecting CE Mark approval and European commercial launch for its RDN system sometime this year. Boston Scientific expects to begin U.S. clinical trials in 2014.
Massachusetts device maker Covidien (NYSE:COV) earlier this month announced global commercial launch of its OneShot renal denervation system, which Covidien gained through the April 2012 acquisition of Maya Medical in a deal worth up to $230 million,. The company plans over the next few months to roll out the device in markets in Europe, the Middle East, Africa, Asia and Latin America.
No renal denervation system has yet been cleared for the U.S. market.