Medtronic receives CE Mark for its next generation Micra leadless pacing systems

Rhea-AI Summary

Medtronic plc (MDT) has received CE Mark for its Micra™ AV2 and Micra™ VR2, the next generation of its miniature, leadless pacemakers. The new pacemakers offer 40% more battery life, projecting a battery life of nearly 16 and 17 years, respectively. Additionally, they are the world's smallest pacemakers and the only leadless pacemakers with remote monitoring capabilities, providing significant benefits to patients. Medtronic's legacy in cardiac pacing includes several groundbreaking innovations, positioning the company as a leader in the industry.

Positive

• CE Mark approval for Micra AV2 and VR2 signifies a significant milestone for Medtronic, enhancing its position in the cardiac pacing market.
• The new pacemakers offer a substantial increase in battery life, projecting a battery life of nearly 16 and 17 years, respectively, which is a remarkable advancement in the industry.
• Micra devices are the world's smallest pacemakers and the only leadless pacemakers with remote monitoring capabilities, providing patients with additional benefits and convenience.

Negative

• None.

Insights

Cardiology Expert

The introduction of Medtronic's Micra AV2 and VR2 pacemakers represents a significant advancement in cardiac pacing technology. The 40% increase in battery life is a considerable improvement, which translates to nearly 16 to 17 years of device functionality before a replacement might be necessary. This longevity is crucial for patients, as it reduces the frequency of invasive procedures needed for device replacement, thereby minimizing the associated risks and healthcare costs.

Furthermore, the leadless design of these pacemakers mitigates common complications associated with traditional pacemakers, such as lead dislodgement or infection. The smaller size of the device also enhances patient comfort and reduces the psychological impact of having a visible pacemaker pocket. These improvements not only contribute to better patient outcomes but also may broaden the patient population eligible for this technology.

Medical Device Market Analyst

Medtronic's CE Mark approval for the Micra AV2 and VR2 pacemakers is a strategic milestone that strengthens its position in the cardiac pacing market. The approval indicates compliance with European health, safety and environmental protection standards, allowing Medtronic to expand its market reach within the European Economic Area. The remote monitoring capabilities of these devices align with the growing trend towards telemedicine and patient-centric healthcare solutions, potentially increasing their adoption rate.

The leadless pacemaker market is expected to grow due to the aging population and the increasing prevalence of cardiovascular diseases. Medtronic's pioneering efforts in this field, coupled with its history of innovation, position it favorably against competitors. The extended battery life and reduced need for replacements could also lead to cost savings for healthcare systems over time, which may influence purchasing decisions and enhance Medtronic's market share.

Healthcare Economist

The extended battery life of Medtronic's new pacemakers could have substantial economic implications for the healthcare system. By potentially reducing the number of device replacements needed over a patient's lifetime, there could be significant cost savings in terms of both the devices themselves and the surgical procedures required for implantation. Additionally, remote monitoring capabilities can decrease the need for routine follow-up visits, thereby saving on healthcare resources and reducing patient travel costs.

However, the upfront cost of these advanced devices compared to traditional pacemakers must be considered. While the long-term savings are evident, the initial investment may be higher, which could impact healthcare budgets and insurance coverage decisions. The economic benefits, therefore, need to be evaluated against the short-term financial implications for widespread adoption to occur.

New pacemakers offer 40% more battery life,¹ extend Medtronic legacy of pacing leadership

DUBLIN, Jan. 5, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniature, leadless pacemakers.

Micra AV2 and Micra VR2, the world's smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.²

With approximately 40% more battery life compared to previous generations,¹ Medtronic projects the battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively.³ This means more than 80% of patients who receive a Micra may only require one device for life.³

This CE Mark milestone follows U.S. Food and Drug Administration approval for the Micra AV2 and VR2 devices in 2023.

In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient's heart device without the need for a patient to travel to their clinic for an in-person appointment.  Other patient benefits of remote monitoring may include a reduction in hospitalizations and increase in sense of security.^4,5

"For more than eight years, our Micra leadless pacemakers have provided meaningful benefits to people in Europe who require a pacemaker. Now, these patients have access to the latest leadless pacing technology that, for most of them, may be the only device they will ever need," said Robert C. Kowal, M.D., Ph.D., general manager, Cardiac Pacing Therapies within the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic.

"The first generation of leadless Micra pacemakers demonstrated a significant reduction in major complications, and this next generation of Micra brings several additional benefits including greater longevity, and specifically for the Micra AV2, new algorithms to optimize AV synchrony at faster heart rates while requiring less in-office programming," said Prof. Dr. Christophe Garweg, Cardiologist at University Hospitals of Leuven, Belgium. "These advantages likely will expand the use of the leadless pacemaker to more patients."

Globally, more than 200,000 patients have received Micra pacemakers.⁶ Comparable in size to a large vitamin, Micra pacemakers are less than one-tenth the size of traditional pacemakers. Unlike traditional pacemakers, Micra pacemakers do not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are eliminated, and there is no visible sign of the device.

Leaders in Cardiac Pacing
Receiving CE Mark for Micra AV2 and VR2 builds on the Medtronic legacy in cardiac pacing, which includes:

1. Inventing the first wearable pacemaker in 1957.
2. Launching the first pacemaker for use in MRIs in 2011.
3. Creating and launching the first leadless pacemaker in 2015.
4. Launching the first leadless pacemaker to coordinate the heart's electrical signals by sensing atrial activity, without a lead or device in the atria, in 2020.
5. Gaining regulatory approval for the first pacing system to activate the heart's natural electrical system, conduction system pacing (approval via the His-bundle in 2018 and via the left bundle branch area in 2022).
6. Receiving U.S. approval for Micra AV2 and VR2 in 2023.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References:

¹ Escalante K. Micra AV2 and Micra VR2 longevity comparison. 2023. Medtronic Data on File.

² El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. December 2018;15(12):1800-1807.

³ Sheldon T, Escalante K, and Fagan D. Device Longevity and AV Synchrony Algorithm Modeling of a Leadless Pacemaker Family: A Virtual Patient Analysis. January 2023. Medtronic Data on File.

⁴ Piccini JP, Mittal S, Snell J, Prillinger JB, Dalal N, Varma N. Impact of remote monitoring on clinical events and associated health care utilization: A nationwide assessment. Heart Rhythm. 2016 Dec;13(12):2279-2286. doi: 10.1016/j.hrthm.2016.08.024. Epub 2016 Aug 17. PMID: 27544748.

⁵ Artico J, Zecchin M, Fantasia AZ, Skerl G, Ortis B, Franco S, Albani S, Barbati G, Cristallini J, Sinagra G. Long-term patient satisfaction with implanted device remote monitoring: a comparison among different systems. Journal of Cardiovascular Medicine. 2019 Aug 1;20(8):542-50^.

⁶ Leick, A. Micra "Largest Reach" supporting data. September 2023. Medtronic Data on file.

Contacts:
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Public Relations	Investor Relations
+1-763-242-8241	+1-763-505-4626

 

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SOURCE Medtronic plc

FAQ

What is the significance of Medtronic plc receiving CE Mark for Micra AV2 and Micra VR2?

The CE Mark approval signifies a significant milestone for Medtronic, enhancing its position in the cardiac pacing market.

How much more battery life do the new pacemakers offer compared to previous generations?

The new pacemakers offer approximately 40% more battery life, projecting a battery life of nearly 16 and 17 years, respectively, which is a remarkable advancement in the industry.

What makes Micra devices unique compared to other pacemakers?

Micra devices are the world's smallest pacemakers and the only leadless pacemakers with remote monitoring capabilities, providing patients with additional benefits and convenience.

What is Medtronic's legacy in cardiac pacing?

Medtronic has a strong legacy in cardiac pacing, including several groundbreaking innovations such as inventing the first wearable pacemaker and launching the first leadless pacemaker.

How many patients have received Micra pacemakers globally?

Globally, more than 200,000 patients have received Micra pacemakers, highlighting the widespread adoption and success of the technology.

What are the potential benefits of remote monitoring for patients with Micra pacemakers?

Remote monitoring may include a reduction in hospitalizations and an increase in the sense of security for patients, providing significant advantages in patient care.