 Jan. 07, 2020: U.S. FDA approved Abbott’s HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery.
The new, less persistent approach is designed in order to provide surgeons a choice in surgical method for patients receiving the HeartMate 3™ Left Ventricular Assist Device (LVAD), the industry’s leading heart pump.
Around 615,000 people in the U.S. are living with heart failure and almost 40% are considered to have reached an advanced stage where traditional therapies no longer work. Heart pumps are small, implantable mechanical devices that pump blood through the body in the people whose heart is too weak to do so on its own.
People living with a heart pump may be waiting for a heart transplant or may not be candidates for the transplant and will live with the device for the rest of their life.
Abbott’s HeartMate 3 heart pump can now be implanted using lateral thoracotomy – a surgical approach where an incision is made between a patient’s ribs to access the heart.
The approval is based on two studies – the ELEVATE study: a multi-center, controlled, observational registry collecting post-marketing data, and the LAT Feasibility study: a single arm, prospective, multicenter study.
Results of two trials found that the bleeding (requiring surgery), infection and arrhythmias were lower in the group implanted via the less-invasive surgical approach than those who underwent open heart surgery.
The HeartMate 3 received approval from the FDA in 2017 for the patients with advanced heart failure whose hearts are unable to circulate blood through the body, and are waiting for a transplant, known as bridge to transplant.
In 2018, HeartMate 3 was approved as a destination therapy for those individuals who require a new heart but are not eligible for a transplant.https://abbott.mediaroom.com/2020-01-07-FDA-Approves-Less-Invasive-Surgical-Approach-for-Abbotts-Heart-Pump-to-Help-Patients-Avoid-Open-Heart-Surgery
