Updated to include commentary from Impulse Dynamics.
The FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation.
The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the heart muscle. An FDA advisory panel last December recommended approval for Optimizer Smart, voting voted 12-1 on safety, 11-2 on efficacy and 12-0, with a single abstention, that its benefits outweigh the risks. The system has had CE Mark approval in the European Union since 2002.
The FDA indication covers patients with chronic, moderate-to-severe heart failure who can’t be treated with other devices.
“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” FDA director of cardiovascular devices Dr. Bram Zuckerman said in prepared remarks. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our breakthrough device program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness.”
The federal safety watchdog said it based the approval on a pair of trials covering 389 patients, all of whom received optimal medical therapy; 191 or 49.1% were treated with the Optimizer Smart device. Patients with the implant showed improved six-minute walking tests and improved heart failure symptoms, the agency said.
Impulse Dynamics touted the system as the first and only FDA-cleared CCM to improve 6-minute hall walk distance, quality of life and functional status for NYHA Class III heart failure patients who remain symptomatic despite driected medical therapy and who are in normal sinus rhythm, not indicated for CRT with an LVEF ranging from 25% to 45%.
The company said that CCM is a unique electrical pulse delivered during the absolute refractory period just after the heart contracts, which works by modulating the strength of the heart muscle contraction rather than the rhythm.
“FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm. We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations,” Impulse Dynamics medical advisor Dr. Daniel Burkhoff said in a prepared statement.
The company said that it plans to launch the device in the U.S. later this year.
“We are extremely excited that the Optimizer Smart System with CCM therapy is now available in the United States,” he said. “We look forward to growing our commercial presence in the US and globally,” CEO Dr. Simos Kedikoglou said in a press release.