FDA approves alternative approach for Abbot HeartMate 3 heart pump
pharmafile | January 8, 2020 | News story | Research and Development | Abbott, FDA, Heart Pump, US Pharma, heart disease
The FDA announced today that it has approved a new alternative surgical technique for Abbot’s HeartMate 3 heart pump.
The less invasive approach is designed to provide surgeons with a choice in the surgical method it uses to install this pump. This is to allow patients to avoid open-heart surgery.
Open-heart surgery has been the conventional way these types of pumps have been installed. With the FDA’s decision, Abbott’s HeartMate 3 heart pump can now be implanted via lateral thoracotomy. This is a surgical approach where an incision is made between a patient’s ribs to gain access to the heart.
Igor Gosev, a heart surgeon at University of Rochester Medical Center, commented on the FDA decision and said: “This is a significant advancement for patients who can now receive a life-saving LVAD through an alternative procedure that can yield shorter hospital stays and a faster recovery.”
Robert L. Kormos, Medical Director for Mechanical Circulatory Support at Abbot, also commented saying: “The first approved LVAD—HeartMate I—was approved more than 25 years ago. Since that time, the technology has evolved immensely. Today’s HeartMate 3 device, including its design and size, allows physicians to successfully implant it without having to perform open heart surgery and offers survival rates, as demonstrated in the MOMENTUM 3 clinical trial, at two-years that are comparable to heart transplants.”
The FDA’s approval is based on two studies, the ELEVATE study and the LAT Feasibility study. The results combined showed that bleeding, infection and arrhythmias were lower in the group that was given the less invasive surgical approach compared to those who underwent open heart surgery.
In the US, 615,000 people are living with heart failure with nearly 40% reaching an advanced stage where traditional therapies no longer work. Heart pumps help these patients cope with the condition, as it pumps blood through the body.
Conor Kavanagh
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