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Medtronic's Freezor Xtra Catheter Gains FDA Nod for AVNRT

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Medical device major Medtronic plc (MDT - Free Report) recently announced the receipt of U.S. FDA approval for its Freezor Xtra Cryoablation Catheter to treat patients with atrioventricular nodal re-entrant tachycardia (AVNRT). The Freezor Xtra Catheter is a flexible, single-use instrument used to freeze cardiac tissue and obstruct unnecessary electrical signals within the heart. The new catheter has been developed under the AF Solutions business which is part of the Cardiac and Vascular Group at Medtronic.

Notably, AVNRT is a type of abnormal fast heart rhythm which occurs most commonly in women rather than men. The main symptom of the disease is palpitations. Frequent attacks may require radiofrequency ablation, in which the abnormally conducting tissue in the heart is destroyed.

The expanded indication for Medtronic’s latest catheter is supported by data from the Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia (ICY-AVNRT) clinical study. The results established safety and effectiveness of the Freezor Xtra Catheter for the treatment of patients with AVNRT. With 397 enrolled patients in 34 clinical trial sites across the U.S. and Canada, the study showed recovery from AVNRT was 92.6% at six months post-procedure.  

Reportedly, more than 49,000 people are diagnosed with this critical heart ailment every year. It is claimed that the expanded indication for this catheter will offer a safe and efficient therapy to patients with AVNRT.

As per a recent Zion Market Research report, the global cardiovascular monitoring and diagnostic devices market was valued at around $1.70 billion in 2015 and is expected to reach almost $2.60 billion by 2021, at a CAGR of around 7.0%. This is because of the rising incidence of death in men and women due to varying heart diseases.

Thus, Medtronic’s Cardiac and Vascular segment is working to offer a wide range of innovative technology for interventional and surgical treatment of cardiac problems. Very recently, management added a new set of tools in a bid to expand its coronary stents portfolio. In the last reported second quarter of 2017, the company made developments in its AF Solutions business. These included the launch of Reveal LINQ Insertable Cardiac Monitor System in Japan and FDA approval for its CRT-D SureScan device for the treatment of heart failure.

 Share Price Movement

Medtronic has been facing a rough patch over the last three months as its share price has consistently traded below the Zacks categorized Medical - Products industry. As per the latest movement, the stock is down 4%, comparing unfavorably with the 4.3% gain of the broader industry.

Additionally, the company has seen five downward revisions with no upward movement for the full year over the last two months. Similarly, for the same period, current year estimates have slid from $4.57 to $4.56. However, the company’s portfolio expansion, regulatory approvals and gain in the global market are expected to boost the stock price.

 Zacks Rank & Key Picks

Medtronic currently has a Zacks Rank #4 (Sell). Better-ranked medical stocks are Glaukos Corporation (GKOS - Free Report) , Cardiovascular Systems and Neogen Corp. (NEOG - Free Report) . Glaukos sports a Zacks Rank #1 (Strong Buy) while Cardiovascular Systems and Neogen carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Glaukos gained over 100% in the last one year in comparison to the S&P 500’s gain of 22.4%. The company has a stellar four-quarter average earnings surprise of over 100%.

Cardiovascular Systems surged over 100% in the last one year in comparison to the S&P 500. It has a four-quarter average earnings surprise of 67.8%.

Neogen gained 34.6% in the past one year, better than the S&P 500 mark. The stock has an impressive long-term earnings growth rate of 16.7% for the next five years compared to the industry average of 15.2%.

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