KUALA LUMPUR, June 14 (Bernama) -- Impulse Dynamics, a commercial-stage medical device company focused on delivering CCM therapy to people with heart failure, announced that the first implants in Europe for the newly launched Optimizer® Smart Mini device were recently completed in Italy.
According to a statement, the company announced the launch of the new technology on April 29, 2022, and the first U.S. implants on May 10, 2022.
In March 2022, the company announced that its quality management system received certification under the new European Union Medical Device Regulation.
The new components of the Optimizer Smart Mini system are equally important across international markets, including a rechargeable battery with a 20-year life and new internal technology with improved programming and potential for remote monitoring in a smaller design to make the implant procedure easier for patients and physicians.
“The pace of this international rollout is a reflection of our commitment to delivering innovation that is relevant to patients worldwide,” said Mateusz Zelewski, MD, Impulse Dynamics’ Vice President International.
“It is exciting to see how quickly we can increase access to new and better technology that offers hope for more patients living with heart failure.”
The Optimizer Smart Mini delivers CCM therapy, which consists of electric pulses applied to the heart between heartbeats and serves to enhance the performance of cardiac muscular contraction, making the heart work more efficiently without increasing the heart rate or the oxygen consumption of the cardiac muscle.
CCM therapy is currently indicated in Europe to reduce hospitalisations and improve physical exercise tolerance, quality of life, and functional status for a large population of patients with systolic heart failure who remain symptomatic despite guideline-directed medical therapy.
To date, CCM therapy has already been used to treat over 7,000 patients worldwide and is available in 44 countries. The therapy has been studied in almost 2,000patients and has appeared in more than 100 peer-reviewed journal articles.
More details at www.ImpulseDynamics.com.
-- BERNAMA
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