Reflecting Company Commitment to Innovation in Support of Patient Need
MARLTON - Oct. 30, 2023 (GLOBE NEWSWIRE) -- Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole-body MRI-conditional approval for the Optimizer® Smart Mini system from the United States Food and Drug Administration (FDA). The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.
“We are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment,” said Jason Spees, CEO of Impulse Dynamics. “This furthers our commitment to supporting the heart failure patients who benefit from important and life-changing CCM therapy with the Optimizer Smart Mini system.”
“Full body MRI capability is part of our promise to deliver an ongoing pace of innovation,” said David Prutchi, Ph.D., Chief Technology Officer, Impulse Dynamics. “This advance will ensure that patients who can benefit from our CCM therapy are able to pursue the option without limiting important future diagnostic options.”
The Optimizer Smart Mini delivers CCM therapy to the heart. CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart’s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.1 CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA (New York Heart Association) Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT (cardiac resynchronization therapy), and have a left ventricular ejection fraction ranging from 25 to 45 percent.
The Optimizer Smart Mini incorporates a rechargeable battery with 20-year battery life, offering HF diagnostic monitoring that provides important clinical insights to providers to assist in managing their patients with heart failure. This latest generation also offers internal technology with improved programming and a smaller size designed to make the implant procedure faster and easier for patients and physicians.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure 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 heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 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.