Covidien (NYSE:COV) launched into the renal denervation market with a surprise introduction of its OneShot system, which already has CE Mark approval in the European Union.
The OneShot system was acquired through the acquisition of Maya Medical late last month in a deal worth up to $230 million.
Covidien paid $60 million up-front in cash and may pay up to $170 million more in milestone payments, according to the company’s quarterly report.
Covidien enters a field well trod by other market giants, including Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ), and not without reason.
Cleveland Clinic named catheter-based renal denervation to control resistant hypertension the No. 1 innovation for 2012, with the potential to spread to treating chronic kidney disease, insulin resistance and heart failure.
"For the large subsets of patients who have refractory hypertension and are unresponsive to traditional pharmacologic agents, the field of catheter-based renal denervation holds enormous promise," Covidien chief medical officer Mark Turco said in prepared remarks. "We believe that the OneShot system will provide advantages over existing devices and strengthens Covidien’s leadership in delivering best-in-class vascular solutions."
Covidien plans to unveil OneShot system, an irrigated balloon catheter used to deliver radiofrequency energy to nerves on the outer wall of renal arteries, at the upcoming EuroPCR congress is Paris later this month.
The system won CE Mark approval in February and Covidien will this week treat the 1st patient in its post-CE Mark Rapid clinical trial, according to a press release.
Device giants have been racing to be the 1st to bring a renal denervation system to the U.S. market.
Medtronic’s Symplicity system, gained through the January 2011 acquisition of Ardian, is on the road to FDA review with clinical trials approved in the U.S. last summer. The device has CE Mark approval and TGA listing in Australia and last month won clearance from Health Canada.
Minneapolis, Minn.-based Medtronic launched 2 new clinical trials in February evaluating renal denervation with its Symplicity system as a therapy for a series of conditions including hypertension, heart failure and insulin resistance.
Cross-town rival St. Jude in October 2011 launched a feasibility study of its own renal denervation device as a treatment for resistant hypertension, notching 1st use and setting its sights on a "limited market launch" in Europe by the end of this year.
One in 3 U.S. adults today has hypertension, a condition that increases risks for stroke, heart attack and kidney failure, according to Cleveland Clinic, and an estimated 20%-30% of that population falls into the "resistant" category, meaning that the hypertension doesn’t respond to drugs or lifestyles changes.
"Hypertension – not smoking – is the number one risk factor for death in the world," according to the clinic.
