Abbott's Less-Invasive Surgery for Heart Pump Gets FDA Nod

Abbott Laboratories 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 Research And Markets, the global cardiovascular devices market is expected to reach $71.1 billion in 2027 from $40.8 billion in 2018, witnessing a CAGR of 6.5% between 2019 and 2027. Factors like increasing prevalence of cardiovascular diseases, rising developments for cardiovascular devices and increasing elderly population are expected to drive the market.

Given the market potential, the FDA approval has been well-timed.

Developments in Cardiovascular and Neuromodulation

Of late, Abbott has been seeing a slew of developments in its Cardiovascular and Neuromodulation segment.

In September 2019, the company announced new analyses of the COAPT trial, which showed that its MitraClip device is cost effective. The device is likely to increase both life expectancy and quality of life in heart failure patients with secondary mitral regurgitation (MR) or a leaky mitral heart valve as compared to guideline-directed medical therapy (GDMT) alone.

Further, Abbott presented new data that suggests that its investigational TriClip device may offer physicians an effective minimally invasive repair option for patients suffering from a leaky tricuspid valve, a condition also known as tricuspid regurgitation (TR).

Also, Abbott received the FDA clearance for its Proclaim XR recharge-free neurostimulation system for people with chronic pain, marking a significant step for the treatment of issues related to the spinal cord. This neurostimulation system uses Abbott's low-energy BurstDR therapy with the BoldXR low dosing protocol for safe, effective pain relief, with a long-lasting battery.

Price Performance

Shares of Abbott have gained 23.7% in the past year compared with the industry’s 16.7% growth.

Zacks Rank & Stocks to Consider

Currently, Abbott carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Haemonetics Corporation HAE, Medtronic plc MDT and Hill-Rom Holdings, Inc HRC.

Haemonetics, currently flaunting a Zacks Rank #1 (Strong Buy), has a projected long-term earnings growth rate of 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Medtronic’s long-term earnings growth rate is estimated at 7.4%. The company currently carries a Zacks Rank #2 (Buy).

Hill-Rom’s long-term earnings growth rate is estimated at 11.7%. It currently carries a Zacks Rank #2.

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