FDA approved the second-generation programmer in April, and the device is compatible with the CVRx Barostim implantable systems for heart failure patients.
July 12, 2022
CVRx announced today the launch of its second-generation programmer that is compatible with all Barostim implantable systems. FDA approved the new programmer in April.
The Minneapolis, MN-based company said the new programmer has a modernized design, operates on an upgraded cellular network that enables remote view access, and includes an improved user interface intended to simplify implantable pulse generator programming.
"The new Barostim programmer builds upon the earlier model and includes significant enhancements to both hardware and software," said Nadim Yared, president/CEO of CVRx. "This upgrade allows CVRx to continue to provide superior customer support and reflects our commitment to innovating across all aspects of Barostim therapy."
A complete rollout of the new Barostim programmer is planned across the U.S. market throughout 2022.
The Barostim System is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. The implantable device is designed to deliver electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. In addition to FDA approval, the device has a CE mark for heart failure and resistant hypertension in the European Economic Area.
The company's technology earned it a spot among MD+DI's Company of the Year Finalists in 2016. CVRx went public in 2021.
Back in 2015 FDA announced the Expedited Access Pathway (EAP), which was intended to give patients quicker access to innovative medical devices, and CVRx received an EAP designation for its Barostim Therapy in November 2015, making it among the first technologies accepted into that program. The EAP later became part of the 21st Century Cures Act signed into law in December 2016, and the EAP is now known as the Breakthrough Devices Program.
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