CVRx launches a new Barostim programmer

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CVRx today announced the launch of its second-generation programmer compatible with all Barostim implantable systems. The FDA approved the new programmer in April.

The Minneapolis, MN-based company said the new programmer has a modernized design, operates on an improved cellular network that allows remote access, and includes an improved user interface intended to simplify programming of the implantable pulse generator.

“The new Barostim programmer builds on the previous model and includes significant improvements in both hardware and software“, said Nadim Yared, President and CEO of CVRx. “This upgrade allows CVRx to continue to provide superior customer support and reflects our commitment to innovation in all aspects of Barostim therapy.

A full rollout of the new Barostim Controller is planned for the US market throughout 2022.

The Barostim System is the first FDA-approved medical technology that uses neuromodulation to improve symptoms of heart failure. The implantable device is designed to deliver electrical impulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response in the heart. The therapy is designed to restore balance to the autonomic nervous system and thus reduce the symptoms of heart failure. In addition to FDA approval, the device has CE marking for heart failure and resistant hypertension in the European EconOmic area.

The company’s technology earned it a spot as one of MD+DI’s Company of the Year finalists in 2016. CVRx went public in 2021.

In 2015, the FDA announced the Accelerated Access Pathway (EAP), which aimed to give patients faster access to innovative medical devices, and CVRx received an EAP designation for its Barostim therapy in November 2015, which making it one of the first technologies accepted into this program. . EAP then became part of the 21st Century Cures Act enacted in December 2016, and EAP is now known as the Breakthrough Devices Program.

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