CCM therapy is now indicated for symptomatic heart failure patients with diastolic or systolic ventricular dysfunction, offering a broader range of patients a new option for improving quality of life and reducing heart failure hospitalization
Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it received European CE Mark approval for an expanded indication for the Optimizer Smart Mini system, which delivers the company’s proprietary CCM therapy. This new indication now offers millions of patients with diastolic HF a way to alleviate debilitating symptoms, improving their quality of life and reducing hospitalizations related to heart failure.
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“This expanded indication addresses an important unmet clinical need for patients with diastolic HF or HF with preserved ejection fraction (HFpEF), as it is now also called,” said Prof. Stefan Anker, MD, of Charité Berlin, Germany. “These patients currently have only a few effective treatment options, therefore, the new development by Impulse Dynamics is most welcome. HF specialists in Europe now have an approved device-based treatment for diastolic HF patients that has been shown to improve quality of life and to reduce their need for HF-related hospitalizations.”
“Impulse Dynamics has established leadership and commitment to significantly changing the treatment options available for HF patients,” said Jason Spees, CEO of Impulse Dynamics. “The expanded indication for CCM therapy in Europe is a reflection of the company’s drive to provide proven treatment solutions for all HF patients.”
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HF affects more than 64 million people worldwide and causes symptoms like fatigue, shortness of breath, and swelling that can severely limit daily activities and overall quality of life. Diastolic HF accounts for almost half of the HF population and occurs when the heart’s ventricles become stiff and unable to relax properly, preventing them from filling with enough blood between beats. These patients have limited treatment options available for managing their symptoms.
In Europe, the OPTIMIZER Smart Mini system is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic and diastolic left ventricular dysfunction despite appropriate medical therapy. CCM therapy, as delivered by the OPTIMIZER system, has been shown to improve the clinical status, functional capacity, and quality of life, and prevent hospital admissions in patients with symptomatic left heart failure in eligible patients.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure (HF) for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer technology platform, to improve quality of life in HF patients. CCM therapy is delivered through the Optimizer system, which includes an implantable pulse generator (IPG) implanted in a minimally invasive procedure and approved for commercial use in the United States and countries worldwide. More than 10,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them.
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Source – GlobalNewswire
