Minneapolis-based devicemaker CVRx said Monday it has completed enrollment of the Barostim HOPE4HF heart failure study. The implantable Barostim neo device triggers the body’s own natural blood flow regulation system to treat heart failure and hypertension, according to the company.

The randomized, controlled clinical trial will evaluate the performance of Barostim in 140 patients suffering from chronic heart failure with advanced systems, CVRx spokesman Tom Moore told Device Daily Bulletin. The Barostim neo currently is being clinically evaluated for the treatment of hypertension in the U.S.

The Barostim neo received CE Mark approval for the treatment of hypertension on in December 2011, said CVRx Chief Financial Officer John Brintnall. The HOPE4HF trial is being conducted to gain an additional CE Mark for the treatment of heart failure and to provide the basis for designing a larger U.S. trial to gain FDA approval for a heart failure indication, he added.

Meanwhile, the French health ministry has selected Barostim neo for resistant hypertension as one of five investigator-initiated studies it will fund in 2014. The investigator-initiated study to evaluate the incremental cost-effectiveness of Barostim for the treatment of resistant is sponsored by the Nancy University Hospital in France. The study will randomize 128 patients to receive optimal medical management or Barostim neo plus optimal medical management at 13 hypertension centers of excellence across France, CVRx said. — Kellen Owings

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