Abbott's Less-Invasive Surgery For Heart Pump Gets FDA Nod
Zacks Investment Research | Jan 07, 2020 09:23PM ET
Abbott Laboratories (NYSE:ABT) received the FDA’s approval for the implantation of its HeartMate 3 heart pump through minimally invasive surgical procedures, new surgical procedure that is an alternative to open heart surgery for advanced stages of heart failure. The latest offering will provide surgeons an option to decide the surgery type for patients receiving the HeartMate 3 Left Ventricular Assist Device (LVAD), the industry's most popular heart pump.
Notably, the HeartMate 3 received the FDA approval in 2017 for patients with advanced heart failure and was approved in 2018 as a destination therapy for those who require new hearts but are not eligible for a transplant.
With the latest approval, Abbott aims to strengthen its Cardiovascular and Neuromodulation Product portfolio globally.
A Peek Into the Approval
The FDA approval is based on two studies — the ELEVATE study and the LAT Feasibility study. The former is based on a multi-center, voluntary, observational registry collecting post-marketing data, while the latter is a single-arm, prospective, multicenter study. Both studies found that bleeding (requiring surgery), infection and arrhythmias (a condition in which the heart beats with an irregular or abnormal rhythm) were lower in cases of minimally invasive surgery, unlike those undergoing open heart surgery.
Significance of the Approval
Currently, around 615,000 people in the United States alone suffer from heart failure and approximately 40% are considered to have reached an advanced stage, where traditional therapies are no longer useful. Traditionally, such patients had to undergo open heart surgery for heart pump implant.
However, with the approval for an alternative surgical technique, the implantation can be done through minimally invasive surgeries like lateral thoracotomy. This marks an improvement as it will lead to less bleeding and a shorter recovery period. Notably, the HeartMate 3 LVAD is the first LVAD with Full MagLev technology, which is commercially (CE Mark and FDA) approved.
Industry Prospects
Per a report by Original post
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