May 5, 2010 (New York, New York) — In a somewhat strange turn of events, a late-breaking clinical trial slated for presentation here at the American Society of Hypertension (ASH) 2010 Scientific Meeting this morning was pulled from the program at almost the last minute.

Dr George Bakris

Yesterday, the intended presenter, incoming president of ASH, Dr George Bakris, spent 20 minutes telling a press conference all about the Rheos system (CVRx, Minneapolis, MN), a pacemakerlike device intended for surgical implantation in the carotid with the aim of activating the baroreflex and reducing blood pressure. He presented what he called a "sneaky preview" of the first 55 patients in the open-label roll-in phase of the trial; 267 out of a planned 322 subjects so far have been enrolled in the study as a whole, at 42 centers in Europe and the US, he said. The full results would be presented at the ASH meeting in 2011, he added.

But this morning at the late-breaking trials session, at which he was a chair, he told attendees that he received a phone call from the company "last night, saying the results are too preliminary and suggesting the statistical analysis is not ready for prime time." Asked by heartwire whether he could expand further on this, he said: "I can't talk about it. They [the company] are going to put out a statement, probably tomorrow or Friday; read between the lines."

The Rheos system, which employs the company's Baroreflex Activation Therapy, has received a CE Mark and is approved for sale for hypertension patients in Europe, according to the firm's website


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