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Medtronic (MDT) Gets FDA Nod for Micra AV to Treat AV Block
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Medtronic plc (MDT - Free Report) received the FDA’s approval for its latest innovation within the Micra product line — Micra AV — which is the world’s smallest pacemaker with atrioventricular (AV) synchrony to date. The Micra AV is the first and only FDA-approved leadless pacemaker, which is currently offered by the company for the treatment of patients with AV block. Notably, AV block is a condition, where the electrical signals between the heart chambers (the atria and the ventricle) are hampered.
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.
Further, the favorable results obtained were presented at the American Heart Association 2019 Scientific Sessions and published in JACC: Clinical Electrophysiology.
With the approval, Medtronic aims to strengthen its Cardiac and Vascular Group segment globally. Notably, in 2016, the FDA approved the first device from the Micra product line — Micra Transcatheter Pacing System (TPS) — the first leadless pacemaker to treat heart rhythm disorders.
Significance of the Latest Approval
The FDA clearance is significant since Micra AV is the only pacemaker offering advantages of leadless pacing. The latest device is superior to the 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.
Industry Prospects
Per a report by Mordor Intelligence, the cardiovascular devices market is expected to witness a CAGR of 6.3% between 2019 and 2024. Factors like the increasing incidence of cardiovascular diseases and growing elderly population are expected to drive the market.
Given the market potential, the approval is well-timed.
Recent Developments
Of late, Medtronic is winning the headlines with a spree of developments across several of its business arms.
In January 2020, the company announced favorable study results from a large, multi-center randomized controlled trial, which provided superior back pain relief with Differential Target Multiplexed (DTM) Spinal Cord Stimulation (SCS) compared with traditional SCS.
In the same month, Medtronic’s Stealth Autoguide platform was adopted by the Phoenix Children’s Hospital, thus becoming the first-ever health system in the United States to receive and deploy the platform. Notably, the company received the FDA clearance for the system in December 2019.
Again, in January, Medtronic received the CE Mark for its InterStim Micro neurostimulator and InterStim SureScan MRI leads, thus allowing the technologies for commercial sale and clinical use in Europe. The company also received the CE Mark for Percept PC neurostimulator, which is the only Deep Brain Stimulation system with BrainSense technology to be launched in the European Union.
In November, Medtronic’s IN.PACT AV drug-coated balloon was approved by the FDA for the treatment of failing AV access in patients with end-stage renal disease and currently undergoing dialysis.
Price Performance
Shares of Medtronic have gained 38% in the past year compared with the industry’s 19.8% growth.
Zacks Rank & Key Picks
Currently, the company carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space are Haemonetics Corporation (HAE - Free Report) , Hill-Rom Holdings, Inc. and Myomo, Inc. (MYO - Free Report) .
Hill-Rom’s long-term earnings growth rate is estimated at 11.7%. The company presently carries a Zacks Rank of 2 (Buy).
Myomo’s long-term earnings growth rate is expected at 25%. It currently has a Zacks Rank #2.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year.
These 7 were selected because of their superior potential for immediate breakout.
Image: Bigstock
Medtronic (MDT) Gets FDA Nod for Micra AV to Treat AV Block
Medtronic plc (MDT - Free Report) received the FDA’s approval for its latest innovation within the Micra product line — Micra AV — which is the world’s smallest pacemaker with atrioventricular (AV) synchrony to date. The Micra AV is the first and only FDA-approved leadless pacemaker, which is currently offered by the company for the treatment of patients with AV block. Notably, AV block is a condition, where the electrical signals between the heart chambers (the atria and the ventricle) are hampered.
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.
Further, the favorable results obtained were presented at the American Heart Association 2019 Scientific Sessions and published in JACC: Clinical Electrophysiology.
With the approval, Medtronic aims to strengthen its Cardiac and Vascular Group segment globally. Notably, in 2016, the FDA approved the first device from the Micra product line — Micra Transcatheter Pacing System (TPS) — the first leadless pacemaker to treat heart rhythm disorders.
Significance of the Latest Approval
The FDA clearance is significant since Micra AV is the only pacemaker offering advantages of leadless pacing. The latest device is superior to the 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.
Industry Prospects
Per a report by Mordor Intelligence, the cardiovascular devices market is expected to witness a CAGR of 6.3% between 2019 and 2024. Factors like the increasing incidence of cardiovascular diseases and growing elderly population are expected to drive the market.
Given the market potential, the approval is well-timed.
Recent Developments
Of late, Medtronic is winning the headlines with a spree of developments across several of its business arms.
In January 2020, the company announced favorable study results from a large, multi-center randomized controlled trial, which provided superior back pain relief with Differential Target Multiplexed (DTM) Spinal Cord Stimulation (SCS) compared with traditional SCS.
In the same month, Medtronic’s Stealth Autoguide platform was adopted by the Phoenix Children’s Hospital, thus becoming the first-ever health system in the United States to receive and deploy the platform. Notably, the company received the FDA clearance for the system in December 2019.
Again, in January, Medtronic received the CE Mark for its InterStim Micro neurostimulator and InterStim SureScan MRI leads, thus allowing the technologies for commercial sale and clinical use in Europe. The company also received the CE Mark for Percept PC neurostimulator, which is the only Deep Brain Stimulation system with BrainSense technology to be launched in the European Union.
In November, Medtronic’s IN.PACT AV drug-coated balloon was approved by the FDA for the treatment of failing AV access in patients with end-stage renal disease and currently undergoing dialysis.
Price Performance
Shares of Medtronic have gained 38% in the past year compared with the industry’s 19.8% growth.
Zacks Rank & Key Picks
Currently, the company carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space are Haemonetics Corporation (HAE - Free Report) , Hill-Rom Holdings, Inc. and Myomo, Inc. (MYO - Free Report) .
Haemonetics currently sports a Zacks Rank #1 (Strong Buy) and has a projected long-term earnings growth rate of 13.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Hill-Rom’s long-term earnings growth rate is estimated at 11.7%. The company presently carries a Zacks Rank of 2 (Buy).
Myomo’s long-term earnings growth rate is expected at 25%. It currently has a Zacks Rank #2.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.6% per year.
These 7 were selected because of their superior potential for immediate breakout.
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