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Medtronic (MDT) Gets MHLW Approval for Micra AV Sale in Japan

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Medtronic plc (MDT - Free Report) recently announced that the Micra AV Transcatheter Pacing System (TPS) has been approved for sale and reimbursement by Japan's Ministry of Health, Labor and Welfare (MHLW). The company is set to launch the product this month.

The Micra AV is used to treat patients who have atrioventricular (AV) block. It delivers the benefits of leadless pacing to a greater number of patients. The Micra AV is similar in shape and size to the original Micra TPS and features several additional algorithms to detect cardiac movement. This enables the device to adjust ventricle pacing to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block.

The Micra AV authorization is backed by data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which examined the safety and effectiveness of accelerometer-based atrial sensing algorithms.

The latest-MHLW approval expands the number of patients eligible to receive the Micra TPS in Japan. This approval is likely to bolster Medtronic’s Cardiac Rhythm Management business, which is part of the company’s Cardiovascular Portfolio.

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The Micra TPS is the world's smallest as well as the first-ever leadless pacemaker. In 2017, its predecessor, the Micra VR, was authorized in Japan for patients requiring single-chamber pacing only. The Micra TPS gained CE Mark in April 2015 and FDA approval in 2016.

Despite being less than one-tenth the size of traditional pacemakers, the Micra provides advanced pacing technology to patients through a minimally-invasive approach. The Micra does not require leads or a surgical "pocket" under the skin, unlike traditional pacemakers, and it leaves no visible trace of the device.

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Medtronic has been committed to pioneering pacing innovations for physicians and their patients since the introduction of its first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio.

Industry Prospects

Per a report published in Mordor Intelligence, the leadless cardiac pacemaker market is set to witness a CAGR of 10% during 2018-2026. Factors such as an aging population, increasing burden of cardiovascular diseases and several technological advancements are driving the market.

Other Notable Developments

Medtronic engaged in a number of significant developments in January 2022.

The company’s CoreValve Evolut PRO TAVR system gained approval from the National Medical Products Administration (NMPA) to treat severe aortic stenosis in symptomatic patients in China who are at high or extreme risk for open-heart surgery. The Evolut PRO system is the first Medtronic self-expanding transcatheter aortic valve replacement (TAVR) system approved in China. This authorization is based on clinical data from more than 32,000 patients, which demonstrated high survival, low stroke rates, minimal paravalvular leak and excellent hemodynamics (blood flow).

The company entered into a definitive agreement to acquire Affera, Inc. This acquisition broadens Medtronic’s advanced cardiac ablation portfolio to address physician needs in a growing patient population with cardiac arrhythmias. The acquisition is anticipated to close during the first half of Medtronic fiscal year 2023, subject to fulfillment of certain customary closing conditions.

Share Price Performance

The stock has underperformed its industry over the past six months. It has declined 15.3% compared with the industry’s 9% fall.

Zacks Rank and Key Picks

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

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. (AMN - Free Report) , Apollo Endosurgery, Inc. (APEN - Free Report) and Patterson Companies, Inc. (PDCO - Free Report) .

AMN Healthcare, carrying a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 16.2%. The company’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 19.5%, on average.

AMN Healthcare has outperformed its industry over the past year. AMN has gained 51% against the 57.2% industry decline.

Apollo Endosurgery, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 7%. The company‘s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 25.6%, on average. You can see the complete list of today’s Zacks #1 Rank stocks here.

Apollo Endosurgery has outperformed its industry in the past year. APEN has gained 103.1% versus the industry’s 2.2% fall.

Patterson Companies, sporting a Zacks Rank #2, has a long-term earnings growth rate of 9.9%. The company surpassed earnings estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 3.7%.

Patterson Companies has underperformed its industry over the past year. PDCO has declined 10.9% versus the industry’s 4.8% rise.