Reveal LINQ regulatory approvals
In February 2014, Medtronic (MDT) launched the smallest insertable cardiac monitor (or ICM), Reveal LINQ, after securing 510K clearance from the FDA and the CE mark from the European Commission. This device is used to detect irregular heartbeats and can monitor patient’s heart for up to three years.
On September 14, 2016, Japan’s Ministry of Health, Labor, and Welfare (or MHLW) approved and granted reimbursement for this device. The Reveal LINQ ICM, which has TruRhythm Detection, added sensors, and Bluetooth communication capability to the patient’s phone, was approved by the FDA on March 13, 2017.
Reveal LINQ is being used in patients suffering from stroke, syncope, and cryptogenics. It is also increasingly used for patients who may have to undergo atrial fibrillation (or AF) ablation, although this is still a highly underpenetrated market opportunity.
The chart above shows the market opportunity available for REVEAL LINQ in the US and in Western Europe by 2020. With Reveal LINQ, Medtronic is competing effectively with other ECG monitoring players such as St. Jude Medical (STJ), General Electric Company (GE), and Boston Scientific (BSX).
Around 50% of REVEAL LINQ cardiac monitors are purchased by patients suffering from syncope. There are 20% of these syncope patients who may need pacemakers in the future. With 95% of the patients who use Medtronic’s pacemakers, REVEAL LINQ has helped boost activity in the company’s Pacing segment.
As a leading player in the implantable loop recorder segment for past 20 years, Medtronic has seen robust uptake for its subcutaneous and single lead electrocardiographic (or ECG) monitoring device from patients suffering from cryptogenic stroke and syncope in fiscal 2018.
The increasing uptake of REVEAL LINQ devices could push year-over-year revenue growth for Medtronic’s Diagnostics segment into the high single-digit percentages, similar to that witnessed in fiscal 1Q18. If this growth continues for the rest of fiscal 2018, it could boost the company’s stock and the Health Care Select Sector SPDR ETF (XLV). Medtronic makes up ~3.4% of XLV’s total portfolio holdings.
In the next article, we’ll discuss the growth trends for the company’s transcatheter therapies.