Abbott Presents Positive Study Results for Tendyne Device

Zacks

Abbott ABT has been in the spotlight of late on favorable developments in its Medical Device business including its core Structural Heart division. The company recently announced encouraging results from a global study of its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system. Data was presented at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), in Paris.

Although this global study of Tendyne device expects to register up to 350 adult patients, the early results were based on successful implantation of Tendyne device in 97 of the first 100 patients. The patients enrolled under the study suffered from symptomatic mitral regurgitation (MR) and were not eligible for open heart surgery to repair or replace the mitral valve.

Notably, the results at the end of 30 days demonstrated that patients treated with Tendyne witnessed a major reduction of mitral regurgitation symptoms and low mortality rates. Further, the improvement in symptoms was assessed based on New York Heart Association (NYHA) grade severity and the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Tendyne Device in Details

Repositionable, completely retrievable and minimally invasive replacement option — Tendyne Device — is used to treat functional, degenerative and mixed causes of MR that cannot be treated through minimally invasive valve repair or open-heart surgery.

Notably, the Tendyne device is currently under clinical investigation for approval in Europe. Further, the company plans to enroll the first patient under the U.S. pivotal trial for the same in the near term.

A Glimpse of the Structural Heart Business

Abbott’s Structural Heart business maintained an impressive top-line performance. In the last reported quarter, the segment’s sales rose 14.5% on a reported basis.

Notably, the Structural Heart business accounted for 10.7% of total revenues in the broader Medical Device segment. The upside was led by continued double-digit growth of MitraClip — the company’s market-leading device for the repair of MR. In March, the company announced the receipt of national reimbursement in Japan for the same. Notably, in nearly 50 countries, more than 50,000 people have been treated with MitraClip. Ministry of Health Labour and Welfare (MHLW) approved the MitraClip System in Japan last November.

Further, the company announced the receipt of FDA approval for the world’s smallest rotatable, bileaflet mechanical heart valve — Masters HP 15mm. With the approval, the company has expanded the Masters Series portfolio under the Structural Heart business.

Market Prospects

Abbott’s strategy to gain traction in the Structural Heart segment seems to be aligned with data provided by Allied Market Research and data provided by the company. Per the report, the Tanscatheter Mitral Valve Repair & Replacement market is estimated to reach a worth of $1,878 million (both repair and replacement valves) by 2023, at a CAGR of 30% from 2017 to 2023. Per the company, almost one in 10 people over the age of 75 suffer moderate to severe MR.

Share Price Performance

Abbott has been gaining investor confidence on consistently positive results. Over the past six months, the stock has outperformed the industry. The stock has gained 11.3%, in comparison with the industry’s 6.7% gain.

Zacks Rank & Stocks to Consider

Abbott currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical sector are Intuitive Surgical ISRG, Illumina, Inc ILMN and Amedisys, Inc. AMED. While Intuitive Surgical and Illumina sport a Zacks Rank #1 (Strong Buy), Amedisys carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Intuitive Surgical has an expected long-term earnings growth rate of 12.1%.

Illumina has an expected long-term earnings growth rate of 20%.

Amedisys has an expected long-term earnings growth rate of 17.5%.

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