CVRx: Can Devices Succeed Where Drugs Fail for High Blood Pressure?
Executive SummaryWith hypertension reaching pandemic proportions, more and more people are not successfully treated with the drugs that, until now, have been the only therapy. CVRx is the first to develop a device to provide patients with another option.
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The humanitarian device exemption for the Barostim neo legacy implantable electronic stimulator for hypertension is CVRx’ first commercial approval in the U.S. The Minneapolis company is also developing the Barostim therapy for treatment of heart failure
Starting as the first company with a device therapy for resistant hypertension, CVRx was soon competing with the renal denervation avalanche, along with trying to survive the economic collapse and a failed trial. Fortunately, the company had gotten its funding when the getting was good.
With the recent success of Ardian’s Symplicity Renal Denervation System, drug-resistant hypertension has emerged as something of a device market “gold rush.” Some observers estimate there are now as many as 40 companies developing various device-based therapies for resistant hypertension, including most of the big names in the cardiovascular device arena – Medtronic, St. Jude Medical, Boston Scientific, Johnson & Johnson, and Covidien PLC – along with a number of start-ups, all of which are racing to stake a claim in this highly promising market. Only time will tell which companies will be successful – even Medtronic, the first player, has yet to complete its sham-controlled US trial. But the technology’s early promise, along with the sheer size of the opportunity and the acute unmet need, clearly have peaked the interest of investors, manufacturers, and physicians alike, all of whom are chasing after what one participant has called “the next biggest thing in cardiology.”