CCM® Therapy: A Breakthrough Treatment Option for Heart Failure
Category: Analytical/Test
Developers: Impulse Dynamics
United States
Product Description:CCM (Cardiac Contractility Modulation) therapy, delivered by Impulse Dynamics’ the Optimizer, is a breakthrough treatment that can help many people with heart failure feel better and reduce their symptoms. The therapy is designed to improve the heart’s ability to contract by delivering precisely timed pulses of energy directly to the heart. The Optimizer, is the first implantable cardiac device to be granted Breakthrough Device designation by the FDA, get a unanimous vote by an FDA advisory panel, based on safety and efficacy, and then to receive FDA approval. The Optimizer is the first and only FDA-approved device in the United States or elsewhere for the delivery of CCM therapy. The approach was proven to be safe and effective in numerous clinical studies, including several randomized controlled trials, and has now been successfully implanted in over 4,500 patients. Patients often report they have a new sense of hope and a renewed positive outlook on life because they can start doing the things they love again and are able to enjoy spending time with their loved ones.
Developers: Impulse Dynamics
United States
Product Description:CCM (Cardiac Contractility Modulation) therapy, delivered by Impulse Dynamics’ the Optimizer, is a breakthrough treatment that can help many people with heart failure feel better and reduce their symptoms. The therapy is designed to improve the heart’s ability to contract by delivering precisely timed pulses of energy directly to the heart. The Optimizer, is the first implantable cardiac device to be granted Breakthrough Device designation by the FDA, get a unanimous vote by an FDA advisory panel, based on safety and efficacy, and then to receive FDA approval. The Optimizer is the first and only FDA-approved device in the United States or elsewhere for the delivery of CCM therapy. The approach was proven to be safe and effective in numerous clinical studies, including several randomized controlled trials, and has now been successfully implanted in over 4,500 patients. Patients often report they have a new sense of hope and a renewed positive outlook on life because they can start doing the things they love again and are able to enjoy spending time with their loved ones.
Optimizer® System