CVRx introduces CE Mark approved Barostim neo for treatment of uncontrolled hypertension

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CVRx, Inc., a private medical device company, introduced today its second-generation implantable device, the Barostim neo™, for the treatment of uncontrolled hypertension. The Barostim neo features a new unilateral, 1mm electrode and a new smaller, more advanced stimulator to allow for more focused and efficient delivery of therapy. These improvements have led to shorter procedure times and extended longevity.

“We are delighted to receive CE Mark approval for hypertension. The advanced personalization capabilities offered by the Barostim neo enhance long-term efficacy by allowing physicians to adapt therapy as their patient's clinical condition warrants. The latest clinical evidence obtained with the new system is exciting.”

"A therapy that effectively activates the baroreflex is a much-needed weapon in our armamentarium against resistant hypertension," said Professor Dr. Hermann Haller, Director of the Department of Nephrology at Hannover Medical School in Germany, and Principal Investigator for the Barostim neo hypertension trial. "We are very excited about the new Barostim neo system and look forward to be able to provide it to the many patients who need it."

CE Mark

Nadim Yared, president and chief executive officer of CVRx added, "We are delighted to receive CE Mark approval for hypertension. The advanced personalization capabilities offered by the Barostim neo enhance long-term efficacy by allowing physicians to adapt therapy as their patient's clinical condition warrants. The latest clinical evidence obtained with the new system is exciting."

ESC Symposium on August 30

Dr. Eugene Braunwald, the Distinguished Hersey Professor of Medicine at Harvard Medical School, and Chairman of the TIMI Study Group at the Brigham and Women's Hospital; and Dr. Alberto Zanchetti, Professor Emeritus of Internal Medicine at the University of Milan and Scientific Director of the Istituto Auxologico Italiano, will co-chair a symposium titled Baroreflex Activation Therapy for Resistant Hypertension and Heart Failure at the European Society of Cardiology (ESC) Congress 2011 in Paris. The event will take place Tuesday, August 30 from 14:00 to 15:30 in the Sofia Lecture Room. The latest clinical trial results for the Barostim neo will be shared at this symposium.

Presenters include Professor Dr. Peter de Leeuw, University Hospital, Maastricht, Netherlands; Dr. Hani N. Sabbah, Wayne State University, Detroit, Michigan; and Professor Dr. Gerd Hasenfuss, Chair of the Heart Center and Heart Research Center, Göttingen, Germany.

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Comments

  1. Fred Bradford Fred Bradford United States says:

    I am a participant in the first trial of this device. They do not deserve a second trial because the first trial was a total failure. The words like minimally invasive is the biggest lie along with how well the device really works. The FDA is receiving my complaint towards the company after I had a heart attack during the trial. Once i had the heart attack they dropped me from the trial. If it treats damaged hearts it must also damage some. Dont be sold on this without serious consideration of the side effects they do not tell you about. Like nerve damage to your speech and swallow. I have both.

    • craig rasch craig rasch United States says:

      i am the second implant patient in california. the device has worked perfectly for me. i hope the best for fred! without the RHEOS device my heart condition would  have been dangerious besides continuing to degrade as it was in decline at the time of placement. my bp has changed from an average 172/107 to a steady 110/80. thank you CVRX!

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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