Abbott Laboratories ABT recently received the CE Mark for its fourth-generation MitraClip Transcatheter Mitral Valve Repair (TMVR) System, MitraClip G4. It is a renowned minimally invasive mitral valve repair device, which is already approved for use in the United States.
Post the approval, the MitraClip G4 is now eligible for use in Europe and other countries recognizing the CE Mark as a non-surgical option for the treatment of mitral regurgitation (“MR”) or a leaking heart valve (a condition in which the mitral valve does not close completely and allows blood to flow backward into the heart instead of forwards and to the rest of the body).
For investors’ note, the MitraClip system has been commercially available in the United States since 2013 and Europe since 2008.
Notably, data presented at PCR e-Course this year from a real-world clinical study of more than 1,000 MitraClip patients illustrated a high implant success rate and MR reduction to the level of none or trace in patients with either primary or secondary MR at 30 days. This recent data confirms MitraClip's significant impact on patients, including improved clinical outcomes and quality of life.
With the recent approval, Abbott aims to fortify its ground in the global structural heart products business, which is a component of its broader Medical Devices arm.
Significance of the Approval
In current times, MR is one of the most common heart conditions affecting one in 10 adults aged 75 and above. The symptoms of this progressive heart condition can be managed via medication, but it does not treat the leaky valve itself. Prior to the introduction of the MitraClip, open-heart surgery was the standard treatment for MR. However, all patients are not eligible or appropriate for open-heart surgery due to the potential risk of complications stemming from comorbidities, advanced age and other issues.
The availability of the MitraClip G4 system enables the physicians to overcome the aforementioned risks as it provides them with enhancements to MitraClip's first-of-its-kind clip-based technology. Apart from providing advanced steering during implantation, the new delivery system offers a variety of clip sizes for tailored treatment options, depending on the patients' individual needs. The TMVR therapy of the MitraClip can be used as a life-saving treatment option for select patients with primary or secondary MR.
The clip-based MitraClip G4, which can be delivered to the heart through a vein in the leg, improves the heart’s blood pumping efficiency once in place.
Per a report by Markets And Markets, the global structural heart devices market is projected to reach $15.08 billion by 2023 from $8.16 billion in 2017 at a CAGR of 10.2%. Factors like a rising elderly population, increasing demand for minimally invasive procedures and growing incidence of structural heart diseases are likely to drive the market.
Given the market potential, the receipt of the CE Mark will significantly boost Abbott’s business.
Recent Developments in Medical Devices
Of late, Abbott has been witnessing a slew of developments in its Medical Devices business.
The company initiated its LIFE-below-the-knee (BTK) clinical trial to assess the safety and effectiveness of its new Esprit BTK Everolimus Eluting Resorbable Scaffold System this month.
In July, the company’s next-generation Gallant implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator devices were approved by the FDA.
In June, Abbott announced late-breaking data on various products available for the treatment of structural heart diseases. The data included findings on the MitraClip system for transcatheter mitral valve repair and data on two first-in-the-world devices approved in the European Union — the TriClip system for transcatheter tricuspid valve repair and the Tendyne transcatheter mitral valve implantation system for people needing a replacement mitral valve.
In the same month, Abbott, for the first time, commercially introduced the MitraClip therapy to China. The company also received approval in Japan for the MitraClip G4 in the same month.
Shares of the company have gained 23.9% in the past year compared with the S&P 500’s 11.5% growth and against the industry’s 4.9% decline.
Zacks Rank & Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are QIAGEN N.V. QGEN, Thermo Fisher Scientific Inc. TMO and Hologic, Inc. HOLX.
QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently flaunts a Zacks Rank #1. (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Thermo Fisher’s long-term earnings growth rate is estimated at 15.5%. It currently carries a Zacks Rank #2 (Buy).
Hologic’s long-term earnings growth rate is estimated at 16.4%. The company presently sports a Zacks Rank #1.
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