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Medtronic (MDT) Gets Canada Nod for Micra AV to Treat AV Block
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Following the receipt of the U.S. and European approvals earlier this year, Medtronic plc’s (MDT - Free Report) Micra AV received regulatory go ahead in Canada as well. Micra AV — which is the world’s smallest pacemaker with atrioventricular (AV) synchrony to date — has received a Health Canada license.
As noted by Medtronic Canada ULC, a subsidiary of Medtronic, Micra AV is the first and only Health Canada-licensed 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.
With the approval, Medtronic aims to strengthen its Cardiac and Vascular Group business globally. Notably, in January 2020, the company received the FDA’s approval for this device. In June, it received the CE Mark for the same.
Significance of the Deal
The Canada clearance is significant since Micra AV is the only available pacemaker offering advantages of leadless pacing. The latest device is superior to the traditional dual-chamber pacemakers, which are implanted in the upper chest, below the collar bone and connected to the heart using leads. Micra AV involves a minimally invasive implant procedure of a cosmetically invisible device.
Micra AV is also superior to the company’s original leadless Micra Transcatheter Pacing System (TPS) in a way 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.
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. According to a Medtronic spokesperson, the real-world use of Micra has shown a 63% reduction in major complications compared to traditional transvenous pacemakers.
Huge Prospects in Canada
As published in a Mordor Intelligence report, the Heart and Stroke Foundation 2019 data says that each year more than 62,000 people get an attack with stroke in Canada and that number is expected to rise. The report says that currently over 405,000 people in Canada live with the effects of stroke.
The Heart and Stroke Foundation analysis also says that between 2007 and 2017, there was a 68% increase in hospitalizations across all age groups for heart valve disease.
Based on these, Mordor Intelligence expects the Canada Cardiovascular Devices Market to register a CAGR of 3.8% during the forecast period of 2020 to 2025.
Looking at the high prevalence of heart disease in Canada, we expect Medtronic’s latest development to be well timed.
Recent Development
In September 2020, Medtronic announced first enrollments in the ALLEVIATE-HF clinical trial, which will evaluate the ability of its Reveal LINQ Insertable Cardiac Monitor (ICM) in identifying patients at high-risk of worsening heart failure.
In May 2020, Medtronic announced favorable results from late-breaking clinical trials evaluating the MyCareLink Heart mobile app and the Micra TPS products that while providing optimal care reduce potential exposure between patients and their clinicians.
The same month, the company’s congenital heart disease (CHD) studies show strong 10-year performance for Melody Transcatheter Pulmonary Valve and Primary Results from the Harmony Pivotal Trial.
Price Performance
Shares of Medtronic have gained 22.6% in the past six months compared with the industry’s 12.1% growth.
Zacks Rank & Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Align Technology has a projected long-term earnings growth rate of 18.3%.
DaVita has a projected long-term earnings growth rate of 18.3%.
Thermo Fisher has an estimated long-term earnings growth rate of 18%.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Medtronic (MDT) Gets Canada Nod for Micra AV to Treat AV Block
Following the receipt of the U.S. and European approvals earlier this year, Medtronic plc’s (MDT - Free Report) Micra AV received regulatory go ahead in Canada as well. Micra AV — which is the world’s smallest pacemaker with atrioventricular (AV) synchrony to date — has received a Health Canada license.
As noted by Medtronic Canada ULC, a subsidiary of Medtronic, Micra AV is the first and only Health Canada-licensed 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.
With the approval, Medtronic aims to strengthen its Cardiac and Vascular Group business globally. Notably, in January 2020, the company received the FDA’s approval for this device. In June, it received the CE Mark for the same.
Significance of the Deal
The Canada clearance is significant since Micra AV is the only available pacemaker offering advantages of leadless pacing. The latest device is superior to the traditional dual-chamber pacemakers, which are implanted in the upper chest, below the collar bone and connected to the heart using leads. Micra AV involves a minimally invasive implant procedure of a cosmetically invisible device.
Micra AV is also superior to the company’s original leadless Micra Transcatheter Pacing System (TPS) in a way 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.
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. According to a Medtronic spokesperson, the real-world use of Micra has shown a 63% reduction in major complications compared to traditional transvenous pacemakers.
Huge Prospects in Canada
As published in a Mordor Intelligence report, the Heart and Stroke Foundation 2019 data says that each year more than 62,000 people get an attack with stroke in Canada and that number is expected to rise. The report says that currently over 405,000 people in Canada live with the effects of stroke.
The Heart and Stroke Foundation analysis also says that between 2007 and 2017, there was a 68% increase in hospitalizations across all age groups for heart valve disease.
Based on these, Mordor Intelligence expects the Canada Cardiovascular Devices Market to register a CAGR of 3.8% during the forecast period of 2020 to 2025.
Looking at the high prevalence of heart disease in Canada, we expect Medtronic’s latest development to be well timed.
Recent Development
In September 2020, Medtronic announced first enrollments in the ALLEVIATE-HF clinical trial, which will evaluate the ability of its Reveal LINQ Insertable Cardiac Monitor (ICM) in identifying patients at high-risk of worsening heart failure.
In May 2020, Medtronic announced favorable results from late-breaking clinical trials evaluating the MyCareLink Heart mobile app and the Micra TPS products that while providing optimal care reduce potential exposure between patients and their clinicians.
The same month, the company’s congenital heart disease (CHD) studies show strong 10-year performance for Melody Transcatheter Pulmonary Valve and Primary Results from the Harmony Pivotal Trial.
Price Performance
Shares of Medtronic have gained 22.6% in the past six months compared with the industry’s 12.1% growth.
Zacks Rank & Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Align Technology (ALGN - Free Report) , DaVita Inc (DVA - Free Report) and Thermo Fisher Scientific (TMO - Free Report) , each presently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Align Technology has a projected long-term earnings growth rate of 18.3%.
DaVita has a projected long-term earnings growth rate of 18.3%.
Thermo Fisher has an estimated long-term earnings growth rate of 18%.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>