Abbott Starts GUIDE-HF Clinical Trial for CardioMEMS Device

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In a bid to fortify its Heart Failure business, Abbott ABT recently announced the start of the — GUIDE-HF clinical trial — largest heart failure medical device study in the United States. The trial will evaluate the effectiveness of CardioMEMS HF System in improving the survival and quality of life for patients with New York Heart Association (NYHA) Class II – IV heart failure.

Per Abbott, positive results from the trial will help the company in expanding its customer base as well as provide additional clinical evidence to expand coverage for the CardioMEMS HF System.

What is CardioMEMS HF System?

Featuring a small pressure-sensing device, the FDA-approved CardioMEMS HF System allows physicians to monitor pressure changes before the patient's condition deteriorates, lowering the possibility of hospitalization. Notably, the CardioMEMS device has already been proven its effectiveness for patients with NYHA Class III heart failure.

GUIDE-HF Cinical Trial in Detail

The GUIDE-HF clinical trial will enroll 3,600 patients at 140 hospitals with stage C, NYHA Class II-IV heart failure along with either elevated brain-type natriuretic peptide (BNP) levels or prior heart failure hospitalizations in the past year across North America.  These patients will be enrolled at 140 hospitals.

A Peek in to Heart Failure Business

This business by Abbott has continued to deliver stable top-line performance in recent times. In the last reported quarter, sales within this business improved double-digits.

Notably, the Heart Failure business accounted for 6.3% of total revenues in the broader Medical Device segment. Under the segment, the company made HeartMate 3 commercially available in the United States. Management also informed about working on expanding indications for the product to include destination therapy for patients who are barred from opting for transplants.

Market Prospects

Per a report by GlobalData published on Drug Development & Delivery, the heart failure market is estimated to reach a value of $11.8 billion by 2025, at a CAGR of 13.7% from 2015 to 2025.

Per the company, over 5.7 million people suffer from heart failure in the United States with around 915,000 more people getting diagnosed with the condition each year. Furthermore, the American Heart Association (AHA) estimates more than 8 million heart failure patients in the United Stated by 2030, with around three million hospitalizations annually.

Thus, positive results from the trial will help Abbott cash in on the opportunities in the heart failure market.

Share Price Movement

Over the past six months, Abbott has been outperforming its industry. The stock has gained 11.5% compared with the industry's 4.8%.

 

Zacks Rank & Key Picks

Abbott carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical sector are Bio-Rad Laboratories BIO, athenahealth, Inc. ATHN and Edwards Lifesciences Corporation EW.

Bio-Rad Laboratories sports a Zacks Rank of 1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. It has long-term expected earnings growth rate of 20%.

athenahealth is a Zacks #1 Ranked player. It has long-term expected earnings growth rate of 21.5%.

Edwards Lifesciences has long-term expected earnings growth rate of 15.1%. The stock carries a Zacks Rank of 2 (Buy).

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