Abbott Laboratories' ( ABT Quick Quote ABT - Free Report) FDA-approved heart pump — HeartMate 3 — recently gained an updated labeling approval from the regulatory body. With the latest labeling update, this device can be implanted in pediatric patients with advanced refractory left ventricular heart failure.
This approval came on the heels of the company’s earlier heart-failure related innovations targeted for pediatric patients. These include the Masters HP, a dime-sized pediatric heart valve, which was approved in 2018, and the Amplatzer Piccolo Occluder, a pea-sized plug that got approval in 2019.
With the latest labeling expansion, Abbott aims to target the untapped pediatric customer base, thereby, strengthening its Cardiovascular and Neuromodulation business in the United States.
The Labeling Expansion at a Glance
The HeartMate 3 left ventricular assist device (LVAD) or heart pump is an implantable device that pumps blood through the body in people with weak hearts. 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. Earlier in 2020, the company received the FDA’s approval for the implantation of HeartMate 3 through minimally-invasive surgical procedures that is an alternative to open heart surgery for advanced stages of heart failure.
With the latest labeling expansion, physicians will get more options to treat pediatric patients who are either awaiting heart transplants or are not eligible to receive a transplant because of potential complications or procedural risks. To note, in the largest global LVAD trial in the world, the HeartMate 3 pump showed a survival rate of 79% at two years.
Significance of the Approval Going by an Allied Academies report , approximately 500-600 pediatric heart transplantation procedures are performed globally every year, which represents around 12% of the total number of heart transplants performed among all patients.
Given the market potential, the labeling expansion is well-timed.
Developments in Cardiovascular and Neuromodulation
For the past year, Abbott has been seeing a slew of developments in its Cardiovascular and Neuromodulation segment.
In November 2020, Abbott announced the receipt of the CE Mark, and approvals in Europe and Australia, respectively, for its new EnSite X EP System and is launching the system throughout the regions.
Earlier in September, the company’s fourth-generation MitraClip Transcatheter Mitral Valve Repair System (MitraClip G4), its minimally-invasive mitral valve repair device in the world, received the CE Mark as a non-surgical option for the treatment of mitral regurgitation (MR) or a leaky heart valve.
Apart from this, earlier this year, it launched TriClip for the tricuspid valve repair and Tendyne, the first product for mitral valve replacement.
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.
Shares of Abbott have gained 24.6% in the past year compared with the
industry’s 3% growth. Zacks Rank & Key Picks
Abbott currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are
Merit Medical Systems, Inc. ( MMSI Quick Quote MMSI - Free Report) , Align Technology, Inc. ( ALGN Quick Quote ALGN - Free Report) and Thermo Fisher Scientific Inc. ( TMO Quick Quote TMO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merit Medical has a projected long-term earnings growth rate of 12.6%.
Align Technology has an estimated long-term earnings growth rate of 18.3%.
Thermo Fisher has a projected long-term earnings growth rate of 18%.
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