|Medtronic's Symplicity has been safe and effective after one year, according to the company--courtesy of Medtronic|
Medtronic ($MDT) is touting positive one-year results for Symplicity, its renal denervation device, reporting that hypertensive patients experienced an average 28 torr drop in blood pressure and maintained those levels after a follow-up. While the data reaffirms the tech's effectiveness, Medtronic is facing mounting competition as more and more devicemakers dive into the much-hyped market.
After a year, none of the study's 106 subjects reported device-related serious adverse events, late vascular complications or significant decline in kidney function, Medtronic says. And the company believes its device, available in Europe, is the most effective for patients with drug-resistant hypertension.
For now, Medtronic is the market leader, as Symplicity has been on the market overseas since 2010 and the company has the FDA's blessing for a large-scale IDE trial designed to get U.S. approval by 2015.
But Medtronic's primacy could be short-lived, as St. Jude Medical ($STJ) has data saying its CE marked EnligHTN works faster, and Boston Scientific ($BSX) made a splash last month with its $425 million buyout of 2012 Fierce 15 winner Vessix Vascular, snapping up the available-in-Europe V2 device. Meanwhile, Covidien ($COV) is eyeing a 2013 overseas launch for its OneShot, and ReCor Medical is in the midst of a post-market surveillance study for Paradise.
And, by the time Medtronic gets Symplicity in front of FDA investigators, the number of players in the renal denervation game will surely have multiplied. Analysts predict the space will bring in about $2.8 billion a year by 2020, and the response from doctors in Europe suggests that the devices will eventually get indicated for general hypertension, not just the drug-resistant variety.
In the past month alone, two private outfits--Kona Medical and Cardiosonic--have ferreted out some venture cash to support renal denervation development, and with potential billions on the line, don't be surprised to see more of the same.
- read Medtronic's results