Impulse Dynamics, developer of the Optimizer Smart system for delivering cardiac contractility modulation (CCM) therapy, has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart system for the treatment of heart failure.
According to a press release, the Optimizer Smart system offers a new therapy for heart failure patients with reduced ejection fraction who are still symptomatic despite receiving guideline-directed medical therapy. The press release says that new algorithms in the two-lead version, of the Optimizer Smart system, deliver therapy in a similar way to the previous version of the device. However, the algorithms no longer require inputs from an atrial lead. Furthermore, recent evidence from the FIX-HF-5C2 clinical study indicates that patients who received the two-lead system experienced better outcomes, including improved peak VO2 (a common measure of exercise tolerance), and fewer device-related complications.
Thomas Mattioni (Scottsdale, USA) says: “I have had the opportunity to provide CCM therapy using both the two-lead and three-lead Optimizer Smart systems. In my opinion, this approval represents an important advancement that will make this breakthrough therapy even more accessible to patients. Patients with Class III heart failure who remain unresponsive to conventional therapy have few options, and CCM is an important addition to our armamentarium in this respect. I have several patients who have had a remarkable response to CCM, and think it is an option that providers should be able to consider for patients who are appropriately indicated.”
The press release describes CCM as a “unique” electrical therapy delivered during the heart’s absolute refractory period. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.
The Optimizer Smart System is the first and only CCM device approved by the FDA to improve six-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for cardiac resynchronisation therapy (CRT), and have a left ventricular ejection fraction (LVEF) ranging from 25% to 45%.
Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first Breakthrough Device to go before the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a unanimous recommendation for approval based on their assessment of benefit versus risk. Optimizer then went on to receive FDA approval on March 21, 2019.