Abbott (ABT) Launches Pivotal Trial TRILUMINATE in the US

Abbott ABT has initiated a pivotal trial in the field of mitral valve repair space to gain a regulatory approval in the United States. This new clinical study — TRILUMINATE — is aimed at evaluating the safety and effectiveness of the company's TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR).

According to Abbott, there are currently no approved transcatheter tricuspid repair treatments available. Also, there is a lack of sanctioned non-surgical, minimally invasive treatments for people with severe TR. TRILUMINATE is the first crucial U.S. Investigational Device Exemption (IDE) trial to evaluate a catheter-based, non-surgical treatment option for patients with severe TR.

Any progress with this will help Abbott extend its structural heart capabilities.

TR and its Prospects in the United States

TR is a condition when the valve doesn't close properly. This induced the blood to flow backward into the heart forcing the heart to work harder than normal to facilitate sufficient blood movement. In severe cases, this condition can potentially cause heart failure if left untreated.

Patients with symptomatic TR are often at an increased risk of conventional surgery. Accordingly, it is vital to assess the effectiveness of a minimally invasive approach in such cases. Undoubtedly, any favorable outcome of the TRILUMINATE study is important as this will widen treatment alternatives for patients with leaky tricuspid valves, who are at high risk of surgery.

The market prospect also seems upbeat as in the United States alone, approximately one in 30 people over the age of 65 suffers moderate-to-severe TR. As there is a dearth of therapy to substitute surgery, Abbott has huge scope in this regard.

Market Prospects

Per Allied Market Research, the transcatheter mitral valve repair & replacement market was valued at $324 million in 2016 and is anticipated to reach a worth of $1.87 billion at a CAGR of 30.0% from 2017 to 2023. 

The Study at a Glance

This is a prospective, multi-center, randomized, controlled global study of approximately 700 patients expected to enroll in the United States, Canada and Europe. Patients will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years.

Notably, the launch of this study came close on the heels of a smaller, single-arm TRILUMINATE trial conducted in Europe and the United States to evaluate the safety and performance of the TriClip repair system. Results from the study showed that after 30 days, 86.6% of patients who received the TriClip device, saw a reduction of at least one grade in TR severity.

Recent Feat of MitraClip

In July, Abbott received an FDA nod for its fourth-generation MitraClip device, MitraClip G4. With this, the company intends to establish a system that would help physicians deliver a personalized, patient-focused therapy as along with more features that can treat both primary and secondary mitral regurgitation.

Price Performance

In the past year, shares of Abbott have surged 31.4%, outperforming the industry’s 3.8% rise.

Zack Rank and Key Picks

Abbott currently curries a Zacks Rank #3 (Hold). A few better-ranked stocks in the broader medical space are Medtronic MDT, Baxter BAX and NuVasive NUVA, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is expected to be 7.13%.

Baxter’s long-term earnings growth rate is projected at 12.8%.

NuVasive’s long-term earnings growth rate is estimated to be 12.75%

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