US-based medical device company Impulse Dynamics has secured the US FDA Supplemental-PMA approval for its next-generation, two-lead Optimizer Smart System intended for the treatment of heart failure.
Impulse Dynamics has designed the Optimizer Smart System as an implantable device to deliver Cardiac Contractility Modulation (CCM) therapy for treating heart failure patients.
Impulse Dynamics commercial operations vice-president Chris Baer said: “With the recent commercial launch of this technology in the U.S. market, we have already seen patients make decisions for CCM therapy that clearly indicate and reinforce the significant gap in therapeutic options for this large population of patients in need. This improvement in our platform allows us to bring innovations that deliver hope to more patients than ever before.”