IMPULSE DYNAMICS: LATE-BREAKING RESULTS SHOW CCM EFFICACY IN PATIENTS WITH HFPEF
KUALA LUMPUR, May 24 (Bernama) -- Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), has announced a late-breaking presentation of results from the CCM-HFpEF Piloty Study.
It is the largest clinical trial to date, studying the effects of the company’s proprietary CCM® therapy to treat HF with preserved ejection fraction (HFpEF), according to a statement.
The results presented — including a substantial 18 point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) quality of life score — indicate that, for patients with heart failure and left ventricular ejection fraction (LVEF) ≥50 per cent, CCM therapy not only offered meaningful improvement in quality of life but also substantially decreased hospitalisations versus the patient’s experience prior to the Optimizer® implant.
The results were presented at the European Society of Cardiology’s Heart Failure 2022 Congress.
Cecilia Linde, MD, Professor and Consultant in Cardiology at the Heart and Vascular Theme of Karolinska University Hospital and the Karolinska Institute in Stockholm, Sweden, who was the co-principal investigator for this investigation, said: “The CCM-HFpEF Pilot Study was conducted to explore the hypothesis that CCM therapy might benefit patients with HFpEF.
“In our CCM-HFpEF-Pilot Study, we found significant benefits from CCM therapy in patients with preserved LVEF, supporting prior findings. I look forward to following the progress of the recently begun pivotal AIM HIGHer trial to continue this journey further.”
Meanwhile, Dr Ishu Rao, Medical Director for Impulse Dynamics, welcomed these results because they confirm the potential for positive results in the company’s recently initiated AIM HIGHer trial.
“We are also excited to announce that enrolment is well underway for this landmark IDE-approved, multicentre, randomised, and blinded pivotal trial designed not only to confirm Dr Linde’s groundbreaking work presented today but to go further yet by providing the first long term morbidity and mortality results for a modern Optimizer CCM device.”
HF affects more than 64 million people worldwide and leads to dramatic declines in a patient’s quality of life. Patients are often classified by a measure of cardiac function known as the ejection fraction (EF), which describes the percentage of blood pumped out of the left ventricle with each heartbeat.
CCM therapy is currently indicated in Europe for patients that have an EF below 50 per cent and has been proven to reduce hospitalisations. However, HF patients with higher EF have had few therapeutic options thus far, to alleviate their symptoms and treat their disease.
CCM therapy for HFpEF has already received the FDA’s breakthrough device designation. The Breakthrough Devices Program is a voluntary programme for certain medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
More details at www.ImpulseDynamics.com.
-- BERNAMA
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