CVRx’s Hypertension Implant Gains FDA Humanitarian Exemption
This article was originally published in The Gray Sheet
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
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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.
Firms must document that humanitarian devices target a rare disease or condition, or a small subset of a common disease or condition, the draft explains.
With 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.