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Two-lead version of implantable pulse generator for HF garners approval
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Impulse Dynamics announced that a two-lead version of its implantable pulse generator to deliver cardiac contractility modulation therapy to patients with HF has been approved by the FDA.
The implantable pulse generator (Optimizer Smart) initially received FDA approval in March after a recommendation by the agency’s Circulatory System Devices Panel in December 2018. The device is indicated for patients with NYHA class III HF who remain symptomatic despite guideline-directed medical therapy, are in sinus rhythm, are not candidates for cardiac resynchronization therapy and have left ventricular ejection fraction of 25% to 45%.
The new version of the device works similarly to the previous generation but does not require inputs from an atrial lead, according to a press release from the company.
In the FIX-HF-5C2 single-arm study, patients who received the two-lead system experienced improved peak VO2 and fewer device-related complications compared with patients from studies of the older system, the company stated in the release.
“The benefits of cardiac contractility modulation have now been proven with evidence-based medicine and in my clinical practice,” Benjamin A. D’Souza, MD, assistant professor of clinical medicine at Penn Medicine, said in the release. “Patients already receive significant benefit from this therapy in its present form and removing the need for an atrial lead is an important advancement for both patients and providers.”
Disclosure: D’Souza reports he is a speaker and consultant for Impulse Dynamics.