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Medtronic Enrolls First Patient Under STOP AF First Trial

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One of the world’s largest medical technology, services and solutions companies, Medtronic plc MDT has been consistently expanding its core structural heart business within Cardiac and Vascular Group. Medtronic recently announced the first enrollment to its STOP AF First clinical trial. STOP AF First is a prospective, interventional, multicenter, randomized, controlled, clinical trial enrolling up to 210 patients in around 30 sites in the U.S. for 12 months.

The trial will assess the safety and effectiveness of pulmonary vein isolation (PVI) when used with the Arctic Front Advance Cryoballoon in symptomatic paroxysmal atrial fibrillation (AF) patients before treating them with antiarrhythmic medications. In other words, this test will determine whether earlier treatment with the Cryoballoon can improve outcome for a greater number of AF patients.

In this regard we note that, according to American Heart Association, AF is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 

First-line treatment of symptomatic paroxysmal AF with the Arctic Front Advance Cryoablation System in the U.S. is currently for investigational use only. The system is approved in the U.S. for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF whereas in Europe for the treatment of AF.

Over the last few years, the problem of arrhythmia has taken an endemic shape globally.

As per the company, over 250,000 patients in 50 countries have been treated with Cryoballoon.

Accordingly, the market for diseases like AF is growing in leaps and bounds. There are 6.1 million AF patients in the U.S. out of 33 million worldwide. The number of AF patients is expected to double over the next 25 years.                              

According to an RnR Market Research report published in CISION PR Newswire, the global AF market is likely to see a CAGR of 13.26% in the 2016–2021 period. North America is a leading market among all the regions. Undoubtedly, the latest development at Medtronic is encouraging.

Over the last six months, Medtronic has been observed to outperform the Zacks categorized Medical - Products industry. As per the latest share price movement, the company has gained 16.9%, as compared to the 15.3% gain of the broader industry.

Recent Developments

Of late, Medtronic’s Cardiac and Vascular Group has made several developments. Notably, in April, the company received FDA clearance for Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, CoreValveEvolutPRO valve and Melody Transcatheter Pulmonary Valve (TPV) for less-invasive treatment.

The company also unveiled results from a new clinical study evaluating Insertable Cardiac Monitors (ICMs). These devices detect high incidence of AF in patients previously undiagnosed but suspected to be at high-risk for AF and stroke.

Also, the company recently announced positive data on cardiac resynchronization therapy (CRT) devices within the Cardiac and Vascular segment. Data from a latest clinical trial reveals that Medtronic’s CRT devices, when combined with its proprietary AdaptivCRT and EffectiveCRT algorithms, reduce costs of healthcare system and improve therapy delivery in heart failure patients who also suffer from AF.

Zacks Rank & Key Picks

Medtronic currently carries a Zacks Rank #3 (Hold). A few better-ranked medical stocks are Mesa Laboratories, Inc. MLAB, Edwards Lifesciences Corporation EW and Align Technology, Inc. ALGN. Notably, Mesa Laboratories and Edwards Lifesciences sport a Zacks Rank #1 (Strong Buy), while Align Technology carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Mesa Laboratories has a positive earnings surprise of 2.84% over the last four quarters. The stock has added roughly 13.3% over the last three months.

Edwards Lifesciences has a long-term expected earnings growth rate of 15.2%. The stock has gained around 25.6% over the last three months.

Align Technology has an expected long-term adjusted earnings growth of almost 24.1%. The stock has added roughly 34.1% over the last three months.

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