Medtronic Gets CE Mark for Micra AV Pacer to Treat AV Block
Medtronic MDT has reached a new milestone in its pacemaker product line. The company received the CE mark for its Micra AV Transcatheter Stimulation System (TPS), which is the world's smallest pacemaker with atrioventricular (AV) synchrony.
This European approval follows the device's FDA approval in January. With the approval, Medtronic intends to strengthen its Cardiac and Vascular Group segment worldwide.
With the recent release, Micra AV became the first and only CE-approved lead-free pacemaker currently offered by the company for the treatment of patients with AV block. In particular, the AV block is a condition in which the electrical signals between the heart chambers (the atria and the ventricle) are obstructed.
Medtronic is now offering the first and only portfolio of lead-free pacemakers with a CE label, increasing the number of potential candidates for this breakthrough technology worldwide.
According to the medical brotherhood, with the approval of the device, more pacemaker patients can take advantage of a new treatment option. In particular, regulatory approval is based on data from the MARVEL 2 study (Micra Atrial Tracking Using A Ventricular Accelerometer), which evaluates the safety and effectiveness of accelerometer-based atrial detection algorithms.
The results showed that the primary efficacy target was achieved. The results were presented at the American Heart Association 2019 scientific meetings and published in JACC: Clinical Electrophysiology.
We note that the first device in the Micra product line to receive the CE mark was the Micra Transcatheter Pacing System (TPS) - the first lead-free pacemaker to treat cardiac arrhythmias in 2015. The following year, the same device received FDA approval.
Importance of the latest regulatory and market prospects
The latest device is superior to conventional pacemaker devices because it involves a minimally invasive implantation procedure of a cosmetically invisible device. Although complications are rare with conventional devices, they are associated with costly and invasive surgery. However, the use of Micra, unlike its traditional counterparts, has shown a significant decrease in the main complications.
Another advantage of Micra AV over the original Micra TPS is that it has several additional internal atrial detection algorithms that can be used to detect heart movements. This allows the device to adjust pacing in the ventricle to coordinate with the atrium, providing patients with an AV block with synchronous AV pacing therapy.
The CE mark is important because Micra AV is the only pacemaker that offers the benefits of lead-free stimulation in Europe. According to a new study by iData Research in 2019, the European heart surgery market is expected to grow by $ 2.7 billion by 2024 by 2024. Given the market potential, approval is timely.
Value for money
In the past six months, Medtronic has been found to lag behind the industry to which it belongs. The stock lost 16% compared to the industry decline of 8.5%.
Zack's Rank & Key Picks
Medtronic currently has a zacks rank of 4 (sales).
Some better ranked stocks from the broader medical field include Quest Diagnostics Incorporated DGX, Hologic, Inc. HOLX and QIAGEN N.V. QGEN.
Quest Diagnostics' long-term earnings growth rate is forecast to be 7.6%. It currently wears a rank 2 zack (buy). The full list of today's Zacks # 1 Rank (Strong Buy) stocks can be found here.
Hologic's long-term earnings growth rate is estimated at 7%. The company currently has a Zacks rank 2.
QIAGEN's long-term earnings growth rate is estimated at 12.2%. It currently has a rank 1 zack.
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