CVRx has announced the first 10 heart failure patients treated with the Barostim neo system under CE mark approval.
The newly approved therapy was made available to a few select Barostim Heart Failure Centers of Excellence beginning 1 October. German institutions: Asklepios Hospital Altona in Hamburg, The Heart Center of the University of Cologne, Universitatsklinikum Giessen, and Herzzentrum Dresden Universitatsklinik became the first treating patients with the therapy.
Barostim neo is approved for use in heart failure patients having an ejection fraction <35% and in New York Heart Association Functional Class III without restriction on QRS duration, concomitant medical device treatment or presence of atrial fibrillation. The system received the CE mark approval based on patient results from randomised, controlled clinical studies conducted in Europe, Canada and the United States.
“We are very excited to perform the first successful commercially available Barostim heart failure implants in the world. Having performed the first clinical Barostim heart failure implants in 2011 while at the University of Cologne and continuing since, we are very encouraged about the performance of the therapy for our patients. We believe there is a heart failure population who can significantly benefit from Barostim therapy,” says Jochen Muller-Ehmsen from Asklepios Hospital Altona.
“By impacting both limbs of the autonomic nervous system, unique among proposed neuromodulation therapies, Barostim provides integrated autonomic modulation,” explains Marcel Halbach from the Heart Center of the University of Cologne.
“Based on strong collaboration with our heart surgery department we feel very confident in offering Barostim therapy for our heart failure patients,” says Stephan Baldus.
“We are very excited to be one of the first centres to have a successful Barostim neo implant in a patient with heart failure. Barostim therapy is a potential treatment option for narrow QRS patients as well as patients who have been previously treated with cardiac resynchronisation therapy but who are still NYHA Class III with ejection fraction < 35%,” says Christian Hamm from Universitatsklinikum Giessen.
About Barostim therapy
CVRx completed enrolment of a 140 patient randomised, controlled clinical trial to determine the performance of Barostim therapy for patients suffering from chronic heart failure with advanced symptoms. Promising results from an earlier study demonstrating clinical improvement and reduced hospitalisations have been presented and published (European Journal of Heart Failure 2014; 16(9):977-983). The six month results from the randomised, controlled trial are being prepared for publication.
About Barostim neo
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body’s own natural blood flow regulation system to treat patients suffering from chronic heart failure. The therapy is also a treatment option for patients with resistant hypertension. The system works by electrically activating the baroreceptors. By activating this afferent pathway, Barostim restores sympatho-vagal balance by reducing sympathetic activity and increasing parasympathetic activity.
Barostim neo has received CE marking for the treatment of heart failure. It has also received CE marking for the treatment of hypertension. It is under clinical evaluation for the treatment of heart failure and hypertension in the United States.