CVRx said yesterday that it won a humanitarian device exemption from the FDA for its Barostim neo legacy device, to treat drug-resistant hypertension.
The watchdog agency issues HDE approvals for devices that show promise in treating conditions that affect fewer than 4,000 Americans. The approval means that while the device’s effectiveness has yet to be determined, the agency believes its probable benefits outweigh any risks.
CVRx said the approval will allow patients who have been participating in a 5-year study for the device to continue to have access to therapy. The Minneapolis-based company said it also plans to publish 6-month follow-up results from a clinical trial for the product in the treatment of chronic heart failure.
Earlier this week, European regulators approved the Barostim neo system for use with MRI procedures.
CEO Nadim Yared told MassDevice.com in September that the Barostim therapy is designed to influence both the sympathetic and parasympathetic systems, reducing sympathetic activity and increasing parasympathetic activity.
“It’s actually pretty straightforward. Heart failure as a disease is most often due to the fact that the sympathetic signal from the brain to the organ is elevated and the vagus tone is depressed. It’s the same with hypertension, basically. We have a unique platform where we are not targeting either the sympathetic system alone or the parasympathetic system alone,” Yared told us.
CVRx added a $15 million loan from Silicon Valley Bank to the $251 million it’s raised so far. CVRx is negotiating with the FDA on the parameters for clinical trials in the U.S. ahead of pre-market approval bids for both the heart failure indication and the hypertension indication, Yared said (the Minneapolis-based company won CE Mark approval for the treatment of hypertension in August 2011).
