FDA approves first device of this type for heart failure

Diving Brief:

• The FDA announced Thursday that it has approved an implantable device sold by Impulse Dynamics to treat patients with moderate-to-severe clbad III 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 impulse during the refractory period, just after the contraction of the heart, in order to modulate the force of the muscular contraction. It's different from a pacemaker or a defibrillator that regulates the heartbeat.
• Impulse Dynamics announced plans to launch the device on the US market later this year. It is currently available in Europe, China, Brazil, India and more than 40 other countries.

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The device has achieved FDA breakthrough status in 2015 to accelerate its development as it treats a potentially life-threatening disease and is intended to address an important unmet need in patients with moderate to severe chronic heart failure. not benefiting from standard treatments. In December, the system received a 12-0 vote on the benefit / risk ratio of the FDA Medical Devices Advisory Committee.

Patients eligible for the implant are those who have not responded to medical treatment or who can not be treated because of underlying problems. Patients should have a regular heart rate, not be candidates for CRT and have a left ventricular ejection fraction of 25% to 45%, lower than the normal range of 55% to 75%.

About 5.7 million Americans suffer from heart failure, caused by conditions such as high blood pressure and diabetes. Symptoms such as tiredness and swelling of the feet or ankles often limit physical activity. Drugs such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers or beta-blockers may be prescribed to lower blood pressure and reduce blood pressure. pressure on the heart.

Impulse Dynamics stated that only 30% of patients with moderate-to-severe chronic heart failure were candidates for CRT treatment, leaving the majority of patients diagnosed with limited treatment options.

The FDA said that data from two clinical trials involving a total of 389 patients with moderate-to-severe heart failure confirmed the approval of the treatment. All patients received optimal medical treatment and 191 patients also received an implant with the Optimizer Smart system. People treated with the device showed improvements in distance traveled through six-minute tests and improvements in standard badessments to measure symptoms of heart failure.

The agency said the device presented potential complications, including infection, bleeding, aggravated heart failure or problems such as dislodgement or fracture of the implanted bypbad in the heart.

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