Medtronic's LINQ II ICM Gets Multiple Regulatory Approvals

Medtronic plc MDT recently announced the receipt of the FDA approval and the CE Mark for its LINQ II insertable cardiac monitor (“ICM”) with remote programming. Notably, ICM is a new long-term diagnostic device, which is implanted in patients to detect arrhythmias (a condition in which the heart beats with an irregular or abnormal rhythm) associated with conditions such as atrial fibrillation (AF).

The LINQ II device incorporates many of the features of LINQ with TruRhythm, besides other improvements that distinguish the device from other ICMs.

For investors’ note, the ICM will be commercially available in the United States and Europe later this summer.

Notably, Medtronic’s peer, Boston Scientific Corporation BSX, also recently received the FDA 510(k) clearance for its LUX-Dx ICM System.

With multiple regulatory clearances in its stride, Medtronic aims to strengthen its Cardiac Rhythm & Heart Failure business on a global scale. For investors’ note, the Cardiac Rhythm & Heart Failure business is part of the company’s broader Cardiac and Vascular Group.

Significance of the Approval

The remote programming feature of the LINQ II ICM enables physicians to seamlessly connect with their patients through the device, without patients requiring to visit the office or hospital, especially during the ongoing pandemic. Per management, the LINQ II system is expected to improve patient interactions with their physicians and reduce in-office visits.

Another notable feature of the LINQ II ICM is that its longevity is superior to other ICM devices currently available in the market.

The wireless ICM also provides enhanced precision to accurately detect abnormal heart rhythms, thus simplifying the diagnosis and monitoring of patients.

The system also provides physicians with actionable data to help diagnose underlying heart conditions and define treatment protocols for patients with AF or other abnormal heart rhythms.

Industry Prospects

Per a report by Allied Market Research, the global ICM market was valued at $410.4 million in 2016 and is anticipated to reach $678.3 million by 2023, witnessing a CAGR of 7.4%. Factors like growing demand for ICM devices to continuously monitor the heart, rising incidences of cardiovascular diseases and technological advancements are likely to drive the market.

Given the market potential, the receipt of the CE Mark and the FDA clearance bode well for the company.

Recent Developments in Cardiac and Vascular Group

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

The company, in June, announced the receipt of the CE Mark for its Evolut Transcatheter Aortic Valve Implantation system and its subsequent European launch for patients with severe native aortic stenosis who are at low risk of surgical mortality.

In the same month, Medtronic received the CE Mark for its Micra atrioventricular (AV) Transcatheter Pacing System. Per the company, it is the smallest pacemaker with AV synchrony currently available.

Further, in June, 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 lost 22.8% in the past six months compared with the industry’s 9.2% decline and the S&P 500's 2.6%.

Zacks Rank & Stocks to Consider

Currently, Medtronic carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Quest Diagnostics Incorporated DGX and Laboratory Corporation of America Holdings LH or LabCorp.

Quest Diagnostics’ long-term earnings growth rate is projected at 7.6%. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

LabCorp’s long-term earnings growth rate is estimated at 6.1%. The company presently sports a Zacks Rank #1.

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