NEWS

Impulse Dynamics Announces First US Implant in the FIX-HF-5CA Continued Access Study.

Orangeburg, New York. August 7, 2017 – Impulse Dynamics announced today the first implant in the Company’s FIX-HF-5CA Continued Access Study. The FIX-HF-5CA study is a multicenter, prospective, single-arm Continued Access evaluation of the company’s Cardiac Contractility Modulation (CCM) device. Impulse Dynamics proprietary CCM technology delivers non-excitatory electric pulses to the cardiac muscle with the potential for improved exercise capacity and quality of life.

The study allows ongoing access to treatment for up to 250 patients suffering from moderate to severe heart failure, as Impulse Dynamics prepares to submit the PMA application to the FDA for the Optimizer device later this year. The first US implant was performed by Rodrigo Chan MD of the Chan Heart Rhythm Institute in Mesa, Arizona on August 5, 2017.

As part of the Continued Access study, the protocol includes the “Optimizer SMART” device, which is slightly smaller and more physiologically shaped than previous models. “Including the Optimizer SMART in the FIX-HF-5CA study serves patients with heart failure by giving them access to recent improvements in the CCM Technology portfolio” said Dr. Simos Kedikoglou, Impulse Dynamics’ CEO. “We are confident that the data gained in our continued access study will positively contribute to the body of evidence supporting our therapy and look forward to including these results in the PMA submission”

Additional information can be found on the Clinicaltrials.gov website at https://clinicaltrials.gov/ct2/show/NCT03102437

About the Optimizer and CCM Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart’s cardiac cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 4,000 patients and is currently available in the US, Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals.

 

About Impulse Dynamics
Impulse Dynamics is a medical device company dedicated to transforming the treatment of chronic heart failure. With global headquarters in Mount Laurel, N.J., the company has additional offices in; Stuttgart, Germany, Orangeburg, N.Y. and Curacao For more information please visit www.impulse-dynamics.com.

Impulse Dynamics (USA), Inc.
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Mt. Laurel, NJ 08054

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