FDA puts CVRx’s BaroStim heart failure treatment on the fast track

CVRx said today that it won a fast-track designation from the FDA that could shave 1 or 2 years from the timeline to approval for its Barostim Neo heart failure treatment.

The Barostim Neo device is a neurostimulation implant designed to treat heart failure by influencing both the sympathetic and parasympathetic nervous systems, reducing sympathetic activity and increasing parasympathetic activity. The Minneapolis-based company said the FDA put its Beat-HF pivotal trial on its “expedited access pathway,” created in April as an alternative to pre-market or de novo approval for devices designed for conditions with no other treatments.

“We applaud FDA for creating the EAP designation. This comes at a critical time for heart failure physicians, who are actively looking for treatment options for patients who are not adequately managed with current guideline-directed therapies,” Dr. William Abraham of Ohio State University’s Wexner Medical Center said in prepared remarks. “Barostim therapy is designed to activate the baroreflex through the afferent (sensory) pathway causing a simultaneous reduction in sympathetic activity and increase in parasympathetic activity. Restoring autonomic balance leads to a reduction in symptoms and has the potential to significantly improve cardiovascular function and patient outcomes. This mechanism of action is unique to Barostim Therapy when compared to other neuromodulation-based therapies.”

Barostim Neo passed the safety and efficacy endpoints in a 146-patient Phase II trial presented in May at the annual meeting of the Heart Rhythm Society; the device won CE Mark approval in the European Union for the heart failure indication in September 2014.

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