Dive Brief:

• FDA announced Thursday it approved an implantable device sold by Impulse Dynamics to treat patients with Class III moderate to severe heart failure who are not eligible for cardiac resynchronization therapy (CRT).
• The Optimizer Smart system is implanted under the skin in the upper chest and connected to the heart via three leads. It delivers an electrical pulse during the refractory period just after the heart contracts, to modulate the strength of the muscle contraction. This is different from a pacemaker or defibrillator that regulates the heart's rhythm.
• Impulse Dynamics said it plans to launch the device in the U.S. market later this year. It is currently available in Europe, China, Brazil, India and more than 40 other countries.

Dive Insight:

The device gained FDA's breakthrough designation in 2015 to speed its development because it treats a life-threatening disease and is intended to address a significant unmet need in moderate to severe chronic heart failure patients not benefiting from standard treatments. In December, the system received a 12-0 vote on its benefit-to-risk ratio from FDA's Medical Devices Advisory Committee.

Patients eligible for the implant are those who have not responded to medical therapy or who are unable to be treated due to underlying conditions. Patients should have a regular heart rhythm, not be candidates for CRT and have a left ventricular ejection fraction of 25% to 45%, below the normal range of 55% to 75%.

About 5.7 million Americans have heart failure, which is caused by conditions such as high blood pressure and diabetes. Symptoms that include fatigue and swelling in the feet or ankles often limit physical activities. Drugs such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers or beta blockers may be prescribed to lower blood pressure and reduce strain on the heart.

Impulse Dynamics said only 30% of moderate to severe chronic heart failure patients are candidates for CRT, which leaves the majority of patients with the diagnosis with limited treatment options.

FDA said data from two clinical trials that studied a total of 389 patients with moderate to severe heart failure supported approval of the treatment. All patients received optimal medical therapy, and 191 patients also received an Optimizer Smart system implant. Those treated with the device showed improvements in the distance they were able to walk in six-minute tests and improvements on standard assessments to measure heart failure symptoms.

The agency said there are potential complications associated with the device, including infection, bleeding, worsened heart failure or problems such as dislodgement or fracture of the leads implanted in the heart.