The US Food and Drug Administration (FDA) has approved a PMA supplement to Impulse Dynamics for its next-generation, two lead Optimizer Smart System to treat heart failure.
The Optimizer Smart System is designed to treat heart failure patients with reduced ejection fraction who are struggling with the debilitating results of the disease despite undergoing medical therapy directed by guidelines.
The system works on algorithms to deliver therapy just as the previous device. However, it no longer requires inputs from an atrial lead.
Recent evidence from the FIX-HF-5C2 clinical study indicates that the two-lead system therapy has shown better results in patients, including those with enhanced peak VO2 issues.
Scottsdale cardiac electrophysiologist Dr Thomas Mattioni said: “I’ve 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.
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“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 providers should be able to consider for patients who are appropriately indicated.”
Optimizer Smart System is a cardiac contractility modulation (CCM) device to boost six-minute hall-walk distance and functional status of NYHA Class III patients.
Such patients remain symptomatic even after undergoing medical therapy under guidelines, are in normal sinus rhythm not indicated for CRT and have a left ventricular ejection fraction (LVEF) ranging from 25-45%.
As only 30% of moderate to severe chronic heart failure patients are candidates for CRT, the remaining percentage of patients have few options to manage their disease.
In 2015, the Optimizer Smart System secured the Breakthrough Device designation from the FDA. It received FDA approval in March.