Minneapolis medical device maker CVRx Inc. is one step closer to putting to market what it says is the world’s first heart failure neuromodulation device. On Friday, the company announced that it has received premarket approval from the United States Food and Drug Administration (FDA) for the device. The approval enables the company to begin marketing the product, known as Barostim Neo.
Using a pulse generator implanted below the collar bone, the device helps trigger the body’s “own natural blood flow regulation system” to treat heart failure, according to the company’s website.
Approval was granted following a federal regulatory assessment, which included a review of CVRx’s clinical trial data for the device.
The Barostim Neo was designed to treat heart failure as an alternative to other treatments like Cardiac Resynchronization Therapy (CRT), said Michael Zile, professor of medicine at the Medical University of South Carolina in a company press release.
“The Baristom Neo improves the quality of life and the exercise capacity of heart failure patients who previously did not have access to a device-based therapy,” said Zile, who chaired the executive steering committee for the product’s pivotal trial.
The device is intended for heart failure patients suffering from a “reduced ejection fraction.” That happens when the left ventricle of the heart doesn’t pump out blood well enough, according to the University of Wisconsin Hospitals and Clinics.
Approval of the Barostim Neo comes after decades of research in the field of neuromodulation, said CVRx president and CEO Nadim Yared.
Barostim Neo had earlier received “breakthrough” status from the FDA. The designation means the FDA fast-tracked its review of the device.
“We are thrilled to transition to the next stage of our company’s growth,” says Yared, “shifting our focus to the successful adoption of Barostim Neo in the United States and bringing an innovative solution to chronic heart failure patients.”
In 2016, CVRx secured $113 million in financing to help complete a trial for the device.