
Medtronic (NYSE:MDT) touted the launch of its latest renal denervation trial, testing its Symplicity system against drug therapy alone in patients in Japan.
The Japanese trial, spanning 100 patients in 11 centers, will compare patients receiving maximal drug therapy in addition to renal denervation against those receiving just the medication, according to a press release.
"The initiation of the Symplicity system clinical trial in Japan marks a pivotal milestone for the Symplicity clinical program," Medtronic coronary & renal denervation senior vice president said in prepared remarks. "With the initiation of this study, we continue our broad commitment to partner with the global medical community to explore the use of renal denervation in different patient populations."
That’s more good news for the Fridley, Minn.-based medical device titan, which is still riding high on strong results for the technology released at the recent annual meeting of the American College of Cardiology.
Renal denervation is one of the hottest topics in medical devices, with doctors and researchers at this year’s European Society of Cardiology Conference in Boston calling the technological advance a “fountain of youth for blood vessels in patients with therapy resistant hypertension.”
Medtronic has also touted some other wins in Japan, with its Resolute Integrity drug-eluting stents hitting Japanese markets late last month.
Renal denervation has yet to make it to the U.S., but devices Medtronic, St. Jude Medical (NYSE:STJ) and others are on the market in the European Union.
Medtronic is the closest winning FDA approval for renal denervation, with clinical trials approved last summer in the U.S. It’ll have competition from cross-town rival St. Jude, which earlier this year won CE Mark approval in the European Union and touted study results finding that its Enlightn renal denervation system lowered high blood pressure faster than Symplicity.
Covidien (NYSE:COV) recently vaulted into the space with the surprise introduction of its OneShot system, which also has CE Mark approval in the European Union. The OneShot system was gained through the April acquisition of Maya Medical in a deal worth up to $230 million.
Fellow med-tech big-shot Boston Scientific’s (NYSE:BSX) earlier this year unveiled its schedule for renal denervation device development, expecting 1st human use in the 3rd quarter of 2012 for its RDN renal denervation system and predicting CE Mark approval and European commercialization in 2013.