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Abbott Begins BTK Clinical Trial to Evaluate DRS Therapy

Zacks Equity Research

Abbott Laboratories ABT recently 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. Notably, this marks the first Investigational Device Exemption (IDE) trial in the United States which will evaluate a fully-resorbable device for the treatment of blocked arteries BTK or critical limb ischemia (CLI). CLI is mainly observed in people with advanced stages of peripheral artery disease (PAD).

For investors’ note, the trial has sites in Australia, Japan, New Zealand, Singapore and the United States so far.

The trial is expected to be a step toward the strengthening of Abbott’s efforts for the treatment of CLI and in turn, to combat PAD. With this, the company aims to fortify its Medical Devices business on a global scale.

Few Words About Esprit BTK

The Esprit BTK System has been designed to allow the controlled release of everolimus (a drug that acts to retard cell proliferation) to reduce scar tissue growth in the affected area, which can cause vessel blockage. The Esprit BTK System is an investigational device only in the United States.

The Esprit BTK System is superior to traditional metal stents as the former is not a permanent implant. Post implantation, the Esprit BTK System delivers the drug over a few months, promoting healing and then gets naturally resorbed into the body over time. Long-term clinical data from a meta-analysis of randomized Absorb trials suggested that bioresorbable scaffolds might be an acceptable alternative to metallic drug-eluting stents (DES) for many patients with coronary artery disease.

Significance of the Trial

Per management, patients suffering from PAD, when treated with balloon angioplasty, often require repeat procedures on the treated arteries. Due to this reason, a drug-eluting resorbable scaffold (DRS) is best-suited to provide mechanical support for the vessel and reduce the chance of vessel re-narrowing before gradually disappearing over time.

People with CLI experience blocked vessels that impair blood flow to the lower extremities, leading to discomfort and in some cases, limb amputation. Notably, more than 200 million people across the world suffer from PAD. Additionally, up to 40% of patients with CLI undergo amputations, many of which are preventable.

Due to the absence of any DES, drug-coated balloons or bare-metal stents approved for use BTK in the United States, options for BTK treatment are limited. The FDA has granted Esprit BTK breakthrough device designation, thus simplifying review and pre-market approval timelines.

Industry Prospects

Per a report by Credence Research, the global bioresorbable vascular scaffold market was valued at $165.8 million in 2018 and is expected to see a CAGR of 10.3% between 2019 and 2027. Factors like requirement of repeat procedures on the treated arteries and the absence of any obstacle for future interventions, surgery or imaging are likely to drive the market.

Given the market potential, the initiation of the trial is a major achievement for Abbott’s Medical Devices business.

Recent Developments in Medical Devices

Of late, Abbott has been witnessing a slew of developments in its Medical Devices business.

In August, the company announced the first enrolment under the TactiFlex PAF IDE study to assess a new device to treat people suffering from paroxysmal atrial fibrillation, which is a type of irregular heartbeat.

Abbott, in July, received the FDA’s approval for the use of its Patient Controller app on compatible personal Apple‡ smartphone devices.

In the same month, 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.

Price Performance

Shares of the company have gained 23.7% in the past year against the industry’s 3.3% decline and the S&P 500’s 15.7% growth.

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%. It currently carries a Zacks Rank #2 (Buy).

Hologic’s long-term earnings growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.

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