Impulse Dynamics secures US FDA approval for Optimizer Smart System
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.”
Optimizer Smart System delivers therapy heart failure patients
Optimizer Smart System provides a new therapy for heart failure patients with reduced ejection fraction and suffering from the effects of the disease regardless of guideline-directed medical therapy.
The two-lead version of Optimizer Smart works on new algorithms to deliver therapy similar to the previous device, but eliminates the need for inputs from an atrial lead.
The medical devices maker said that the recent results from the FIX-HF-5C2 clinical study of the two-lead system demonstrated better outcomes in patients, including improved tolerance (peak VO2), and less device-related complications.
CCM is an advanced electrical therapy that works by modulating the strength of the heart muscle contraction rather than the rhythm, unlike pacemaker or defibrillator. The therapy is delivered during the heart’s absolute refractory period, which is just after the heart muscle contracts.
Scottsdale, Arizona-based cardiac electrophysiologist 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.
“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.”