Impulse Dynamics has secured approval from the US Food and Drug Administration (FDA) for its Optimizer smart system to treat patients with chronic and moderate-to-severe heart failure.
The Optimizer smart system has been approved to deliver cardiac contractility modulation (CCM) therapy to treat heart failure patients who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat.
CCM is the non-excitatory electrical pulses delivered by the implantable Optimizer device during the absolute refractory period of the heart cycle to enhance systolic contraction of the heart.
FDA’s Center for Devices and Radiological Health cardiovascular devices division director Dr Bram Zuckerman said: “Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do.”
The company secured breakthrough device designation from the FDA for Optimizer smart system in 2015.
Optimizer smart system is claimed to be the first and only CCM device secured FDA approval to improve six-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients.
Optimizer system, which has been implanted in more than 3,500 patients, is currently marketed in Europe, China, Brazil, India, and over 40 other countries across the world.
The company has completed multiple clinical studies for the system, including several randomized controlled trials.
Impulse Dynamics medical advisor Dr Daniel Burkhoff said: “FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm.
“We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.”
With operations in the US, Europe, and Asia, Impulse Dynamics is engaged in the development of electrical therapies for the treatment of chronic heart failure.