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 a Premarket Approval (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 contribute positively 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
Over 3,500 patients worldwide have received CCM through an Optimizer device, an innovative therapy designed for patients with a narrow QRS complex, reduced ejection fraction and advanced heart failure. Impulse Dynamics has completed extensive clinical studies, including several randomized controlled trials, published in articles in over 60 leading medical journals. The Optimizer is approved in the United States for investigational use only. An advanced version of the device, the Optimizer Smart, has been successfully launched in Europe, where it is available in a growing number of cardiology centers.
About Impulse Dynamics
Impulse Dynamics N.V., a member of the Hobart Group companies, is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, Asia and Australia. For more information, please visit www.impulse-dynamics.com.
About the Hobart Group
The Hobart Group develops and commercializes medical technologies that target top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the areas of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies have over 200 scientists, engineers, and regulatory and business experts across four continents, benefitting from clinical expertise and extensive regulatory and international market knowledge across Europe, the United States and Asia. For more information, visit www.hobart-group.com.
CCM and Optimizer are trademarks of Impulse Dynamics N.V.
Director, Investor Relations and
New Business Ventures, Hobart Group