Medtronic's (MDT) Cryoablation Suited for Patients With PAF

Medtronic plc MDT announced two trial results, which illustrated the superiority of the Arctic Front Advance Cardiac Cryoballoon and Freezor MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (“PAF”). The cryoablation treatment has been proved to be superior to the antiarrhythmic drug (“AAD”) treatment.

The first one is the randomized STOP Atrial fibrillation (“AF”) First trial whose primary results were presented as a late-breaking clinical trial at the European Society of Cardiology Congress. The results showed the superiority of cryoablation for treating AF, atrial tachycardia and atrial flutter.

The second trial, Cryo-FIRST, presented a significant improvement in AF-related quality of life with the use of the Medtronic’s cryoablation system. The outcomes of using the cryoablation system were better than the AAD therapy in patients who had not previously received AAD drugs to treat their symptomatic PAF.

For investors’ note, the Arctic Front Advance Cryoablation System is approved in Europe for the treatment of AF. The FDA also expanded the indication for Medtronic’s cryoablation therapy to include the treatment of patients with symptomatic and recurrent persistent AF in addition to patients with drug refractory, recurrent, symptomatic PAF. The FDA has not reviewed the STOP-AF First trial results.

Medtronic’s Cardiac Rhythm & Heart Failure arm within the broader Cardiac and Vascular Group is expected to progress with the latest study outcomes.

Significance of the Study Outcomes

AF is a progressive cardiac condition, impacting more than 33 million people worldwide. Without early intervention, the progression of the condition is associated with a host of cardiac issues and a reduced quality of life. Currently, AAD therapy is a standard first-line treatment for patients with AF.

However, even after treatment with AAD, AF recurs in approximately 50% of patients within a year of therapy onset. Additionally, AAD therapy often causes side effects, leading to many patients discontinuing the treatment.

Cryoablation uses cold energy (freezing) delivered through an inflatable balloon to create scar tissue to interrupt unwanted electrical pathways in the heart. The first trial results indicate that cryoablation can be a potential first-line treatment for these patients. Further, the second trial results show encouraging benefits of the treatment approach on patients’ quality of life.

Industry Prospects

Per a report by Coherent Market Insights, the global cryoablation devices market was valued at $132.4 million in 2018 and is projected to witness a CAGR of 8.5% between 2019 and 2027. Factors like technological development and recurrence of AF even after treatment with AAD are expected to drive the market.

Given the market potential, favorable study outcomes are expected to significantly boost Medtronic’s business.

Recent Developments in Cardiac and Vascular Group

Of late, Medtronic has been witnessing a slew of developments in this business arm.

The company’s Evolut Transcatheter Aortic Valve Replacement system won the FDA’s approval for revised commercial labeling in this month.

Further, in August, Medtronic published a favorable outcome of the IN.PACT arteriovenous (“AV”) Access trial in The New England Journal of Medicine, which demonstrates that the IN.PACT AV drug-coated balloon leads to fewer disruptions in dialysis therapy.

In July, the company received the FDA’s approval and CE Mark for its LINQ II insertable cardiac monitor with remote programming. In the same month, Medtronic announced the start of a prospective, observational, global, multi-center, real-world, post-market study to assess the safety and effectiveness of the Valiant Navion Thoracic Stent Graft System for the treatment of thoracic aortic dissection.

In June, the company announced the receipt of the CE Mark for its Evolut Transcatheter Aortic Valve Implantation system and its subsequent Europe launch for patients with severe native aortic stenosis who are at low risk of surgical mortality. Further, in the same month, Medtronic received the CE Mark for its Micra atrioventricular Transcatheter Pacing System.

Also, Medtronic announced the receipt of the CE Mark for its one-month dual antiplatelet therapy indication to address high bleeding risk patients who are implanted with the Resolute Onyx Drug-Eluting Stent.

Price Performance

Shares of the company have gained 5.1% in the past six months compared with the industry’s 7.2% rise and the S&P 500’s 13.5% growth.

 

 

Zacks Rank & Key Picks

Currently, Medtronic 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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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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