Medtronic MDT achieved a new milestone with respect to its pacemaker product line. The company received the CE Mark for its Micra AV Transcatheter Pacing System (TPS), which is the world’s smallest pacemaker with atrioventricular (AV) synchrony to date.
This European regulatory approval comes after the device’s FDA approval in January. With the approval, Medtronic aims to strengthen its Cardiac and Vascular Group segment globally.
With the latest go-ahead, Micra AV became the first and only CE Mark-approved leadless pacemaker, which is currently offered by the company for the treatment of patients with AV block. Notably, AV block is a condition in which the electrical signals between the heart chambers (the atria and the ventricle) are hampered.
Medtronic now offers the first and only CE Mark approved leadless pacemaker portfolio, expanding the number of potential candidates for this groundbreaking technology throughout the world.
Per the medical fraternity, with the approval of the device, more pacemaker patients will be eligible for a new treatment option. Notably, the regulatory approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, assessing the safety and effectiveness of accelerometer-based atrial sensing algorithms.
The results showed that the primary efficacy objective was met. The results were presented at the American Heart Association 2019 Scientific Sessions and published in JACC: Clinical Electrophysiology.
We note that the first device from the Micra product line that received CE Mark was— Micra Transcatheter Pacing System (TPS) — the first leadless pacemaker to treat heart rhythm disorders in 2015. The following year, the same device got FDA approval.
Significance of the Latest Approval and Market Prospects
The latest device is superior to traditional pacemaker devices as it involves a minimally invasive implant procedure of a cosmetically invisible device. Even though the chances of complications with traditional devices are rare, they do involve costly and invasive surgery. However, the use of Micra has shown a substantial drop in major complications, unlike its traditional counterparts.
Another advantage of Micra AV over the original Micra TPS is that it has several additional internal atrial sensing algorithms, which can detect cardiac movement. This allows the device to adjust pacing in the ventricle to coordinate with the atrium, thus, providing AV synchronous pacing therapy to patients with an AV block.
The CE Mark is significant since Micra AV is the only pacemaker offering advantages of leadless pacing in Europe. Going by a 2019 Businesswire data, according to a new study by iData Research, the $2.7 billion European Cardiac Surgery Market is expected to grow 67% by 2024. Given the market potential, the approval is well-timed.
Over the past six months, Medtronic has been observed to underperform the industry it belongs to. The stock has lost 16% compared with the industry's 8.5% decline.
Zacks Rank & Key Picks
Medtronic currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the broader medical space are Quest Diagnostics Incorporated DGX, Hologic, Inc. HOLX and QIAGEN N.V. QGEN.
Quest Diagnostics’ long-term earnings growth rate is projected at 7.6%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Hologic’s long-term earnings growth rate is estimated at 7%. The company presently has a Zacks Rank #2.
QIAGEN’s long-term earnings growth rate is estimated at 12.2%. It currently sports a Zacks Rank #1.
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