Medtronic Inc announced US Food and Drug Administration approval and commercial release of the InSync Maximo cardiac resynchronisation therapy (CRT) defibrillator system, expanding the company's broad portfolio of industry-leading medical devices to treat heart failure, said a company release.
The InSync Maximo device incorporates proven cardiac resynchronisation therapy to treat heart failure and the capacity to deliver high-output defibrillation energy to stop a lethally fast heart rhythm. With 35 joules of delivered energy and the industry's fastest charge times, InSync Maximo provides the highest margin of safety in treating sudden cardiac arrest. Charge time is the number of seconds between the time the device detects an abnormally fast rhythm in the heart's lower chambers and the moment it is ready to deliver a life-saving defibrillation therapy. The sooner therapy is delivered, the higher the probability of a successful, life-saving defibrillation.
"The InSync Maximo is a good example of a device that reflects Medtronic's mission of working with physicians to develop products that help increase safety for their patients and deliver more value to the health care community," said Steve Mahle, president, Medtronic Cardiac Rhythm Management. "More and more, defibrillators offering 35 joules have become accepted by doctors, and many are adopting it as standard therapy for patients at risk of sudden cardiac arrest. There are 35-joule devices available from other companies, but none that can match the combination of power, charge time, size and longevity that patients will experience throughout the life of the InSync Maximo," he added.
Implantable defibrillation technology has been proven to be more than 98 percent effective in treating potentially lethal heart rhythms that can lead to sudden cardiac arrest. Sudden cardiac arrest kills approximately 450,000 people in the United States each year, more than lung cancer, breast cancer, stroke and AIDS combined.
The InSync Maximo system offers unique anti-tachycardia pacing (ATP) options for pain-free termination of life-threatening fast ventricular tachyarrhythmias. Clinical studies have shown that Medtronic's sophisticated anti-tachycardia pacing function can dramatically reduce shocks for treating ventricular arrhythmias - a significant patient benefit - by as much as 77 per cent, the release says.