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Medtronic's (MDT) Micra TPS CED Study Outcome Favorable
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Medtronic plc (MDT - Free Report) recently presented new data from the Micra Coverage with Evidence Development (CED) Study, which demonstrated a significant reduction in complications and reinterventions with Medtronic’s Micra Transcatheter Pacing System (TPS). The company presented data virtually in a late-breaking trials presentation at the European Society of Cardiology (ESC) Congress 2021.
The data presented at ESC will strengthen the major advantages of leadless pacemakers and support earlier findings that showed reduced risk of complications with Micra TPS. The favorable data will assist physicians and patients in choosing the most suitable, customized pacing option to meet their goals.
The recent development is likely to fortify Medtronic’s Cardiac Rhythm Management business, which is part of its Cardiovascular portfolio.
More on Micra TPS
Micra TPS is a leadless pacemaker option for patients who only require pacing in the right ventricle. The device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device during the implant procedure.
Micra TPS does not require leads or a surgical "pocket" under the skin as compared to traditional pacemakers, thereby eliminating the potential sources of complications related to leads and pockets.
In 2015, Micra TPS received CE Mark and was approved by the FDA in 2016 and is the only leadless pacing system available worldwide.
More on Study
Medtronic’s Micra CED study is a continuously enrolling, observational cohort study which evaluates claims-based complications, utilization and outcomes of Micra TPS in the United States Medicare fee-for-service population. Notably, it is the first study to use CMS administrative claims data to assess clinical outcomes of leadless pacing in the real-world setting and compare outcomes to a contemporaneous cohort of patients implanted with transvenous-VVI pacemakers.
Image Source: Zacks Investment Research
Researchers assessed 6,219 patients implanted with Micra VR PTS and 10,212 patients implanted with traditional TV-VVI pacemakers. While reinterventions and chronic complications were reduced, Micra patients did have more comorbidities than transvenous-VVI patients, although there was no difference in adjusted all-cause mortality at two years.
Study Outcome
The study data demonstrated that the Micra TPS was related with a 38% reduction in reinterventions and a 31% decrease in chronic complications at two years as compared to traditional transvenous VVI pacemakers.
The results further support the relationship of a lower risk of complications with leadless pacing compared with traditional transvenous single chamber pacing. The new data will guide physicians in determining the best pacing options for patients.
A rise in the number of eligible patients, an increasing reimbursement scenario, a growing geriatric population and an increasing incidence of cardiovascular disease are factors driving the market.
Recent Developments
In August 2021, Medtronic announced the receipt of FDA approval for its Evolut FX TAVR system -- the latest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system. The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories in the United States. The limited commercial release is planned for the fall, with a full launch expected in early 2022.
In July 2021, Medtronic announced the FDA clearance for two AccuRhythm AI algorithms for use with the LINQ II insertable cardiac monitor (ICM). AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by LINQ II, enhancing the accuracy of information physicians receive to better diagnose and treat abnormal heart rhythms.
Price Performance
Shares of the company have gained 24.5% in a year’s time compared with the industry’s rise of 9.1%.
Zacks Rank and Key Picks
Currently, Medtronic carries a Zacks Rank #3 (Hold).
Image: Bigstock
Medtronic's (MDT) Micra TPS CED Study Outcome Favorable
Medtronic plc (MDT - Free Report) recently presented new data from the Micra Coverage with Evidence Development (CED) Study, which demonstrated a significant reduction in complications and reinterventions with Medtronic’s Micra Transcatheter Pacing System (TPS). The company presented data virtually in a late-breaking trials presentation at the European Society of Cardiology (ESC) Congress 2021.
The data presented at ESC will strengthen the major advantages of leadless pacemakers and support earlier findings that showed reduced risk of complications with Micra TPS. The favorable data will assist physicians and patients in choosing the most suitable, customized pacing option to meet their goals.
The recent development is likely to fortify Medtronic’s Cardiac Rhythm Management business, which is part of its Cardiovascular portfolio.
More on Micra TPS
Micra TPS is a leadless pacemaker option for patients who only require pacing in the right ventricle. The device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device during the implant procedure.
Micra TPS does not require leads or a surgical "pocket" under the skin as compared to traditional pacemakers, thereby eliminating the potential sources of complications related to leads and pockets.
In 2015, Micra TPS received CE Mark and was approved by the FDA in 2016 and is the only leadless pacing system available worldwide.
More on Study
Medtronic’s Micra CED study is a continuously enrolling, observational cohort study which evaluates claims-based complications, utilization and outcomes of Micra TPS in the United States Medicare fee-for-service population. Notably, it is the first study to use CMS administrative claims data to assess clinical outcomes of leadless pacing in the real-world setting and compare outcomes to a contemporaneous cohort of patients implanted with transvenous-VVI pacemakers.
Researchers assessed 6,219 patients implanted with Micra VR PTS and 10,212 patients implanted with traditional TV-VVI pacemakers. While reinterventions and chronic complications were reduced, Micra patients did have more comorbidities than transvenous-VVI patients, although there was no difference in adjusted all-cause mortality at two years.
Study Outcome
The study data demonstrated that the Micra TPS was related with a 38% reduction in reinterventions and a 31% decrease in chronic complications at two years as compared to traditional transvenous VVI pacemakers.
The results further support the relationship of a lower risk of complications with leadless pacing compared with traditional transvenous single chamber pacing. The new data will guide physicians in determining the best pacing options for patients.
Industry Prospects
Per a report by PERSISTENCE MARKET RESEARCH, the global leadless pacing systems market was worth $29.4million in 2017 and is projected to see a CAGR of 10% by 2025.
A rise in the number of eligible patients, an increasing reimbursement scenario, a growing geriatric population and an increasing incidence of cardiovascular disease are factors driving the market.
Recent Developments
In August 2021, Medtronic announced the receipt of FDA approval for its Evolut FX TAVR system -- the latest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system. The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories in the United States. The limited commercial release is planned for the fall, with a full launch expected in early 2022.
In July 2021, Medtronic announced the FDA clearance for two AccuRhythm AI algorithms for use with the LINQ II insertable cardiac monitor (ICM). AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by LINQ II, enhancing the accuracy of information physicians receive to better diagnose and treat abnormal heart rhythms.
Price Performance
Shares of the company have gained 24.5% in a year’s time compared with the industry’s rise of 9.1%.
Zacks Rank and Key Picks
Currently, Medtronic carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space are Envista Holdings Corporation (NVST - Free Report) , BellRing Brands, Inc. (BRBR - Free Report) and Henry Schein, Inc. (HSIC - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.
Envista Holdings has an estimated long-term earnings growth rate of 27%.
BellRing Brands has an estimated long-term earnings growth rate of 29%.
Henry Schein has a projected long-term earnings growth rate of 14%.