Medtronic receives FDA approval for its next generation Micra leadless pacing systems

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

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its Micra™ AV2 and Micra™ VR2, the next generation of its industry-leading miniaturized, 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 the median projected 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 are projected to only need one device for life. 3

The new Micra AV2 also includes advanced algorithms that automatically program AV synchrony, thereby coordinating the heart's upper and lower chambers. Also, for patients who are active, Micra AV2 has a higher available tracking capability for faster heart rates (increased from 115 to 135 beats per minute for upper limits). 4

"Improved AV synchrony – requiring less in-office reprogramming thanks to algorithm optimization – and longer battery life are major wins for patients," said Camille Frazier-Mills , M.D., MHS, an electrophysiologist at Duke University Health System. "I'm excited to offer my patients the new Micra devices. This best-in-class technology transforms the patient experience by eliminating pocket-related complications, and now reduces the chance that patients will need their device changed in the future."

"Our goal is to improve the patient experience by continuously reinventing our ground-breaking leadless pacemaker," 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. "Since inventing the first battery-operated cardiac pacemakers 65 years ago, Medtronic has transformed pacing technologies to benefit patients, including the nearly 200,000 patients globally who have received a Micra device so far."

Comparable in size to a multivitamin, 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 This FDA approval 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).

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 follow @Medtronic on Twitter 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 Device Manual. April 2023 .

Contacts:


Emily Dornfeld

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-242-8241

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-receives-fda-approval-for-its-next-generation-micra-leadless-pacing-systems-301811516.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

MDT
The Conversation (0)

PrairieSky Announces First Quarter 2024 Results, Record Oil Royalty Production

-

PrairieSky Royalty Ltd. ("PrairieSky" or the "Company") (TSX: PSK) is pleased to announce its first quarter ("Q1 2024") operating and financial results for the three-month period ended March 31, 2024.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

PrairieSky Announces Fourth Quarter And Year-End Results For 2023, Including Record Oil Royalty Production, Strong Leasing Activity And Increased Annual Dividend

PrairieSky Royalty Ltd. (" PrairieSky " or the " Company ") (TSX: PSK) is pleased to announce its fourth quarter (" Q4 2023 ") and year-end operating and financial results for the period ended December 31, 2023. PrairieSky is also pleased to announce a 4% increase in its annual dividend to $1.00 per common share ($0.25 per common share quarterly).

Fourth Quarter Highlights

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

PrairieSky Announces 2023 Third Quarter Results

PrairieSky Royalty Ltd. (" PrairieSky " or the " Company ") (TSX: PSK) is pleased to announce its third quarter (" Q3 2023 ") results for the three-month period ended September 30, 2023.

Third Quarter Highlights

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
doctor with hands together, palms up below digital medical symbols

Innovations and Opportunities in European Healthcare Technologies

In recent years, European companies have emerged as trailblazers in healthcare technology, effectively changing the face of health and patient care. Through innovation, they're not only improving systems, processes and patient outcomes but also saving lives.

These advanced European technologies are often only distributed and implemented exclusively within the European Union. The good news is that it doesn't need to stay this way.

Bringing European healthcare technologies to the North American market can potentially improve healthcare in this part of the world, open up new market opportunities for investors and expose those companies to significant growth capital.

Keep reading...Show less
Illustration of heart attack.

Investing in Cardiovascular MedTech Companies

Cardiovascular diseases remain the leading global cause of death, taking an estimated 17.9 million lives annually, based on data from the World Health Organisation. Over 80 percent of these deaths are due to heart attacks and strokes, while one-third of them occur in people under seventy years of age.

Efforts to address the core risk factors associated with cardiovascular diseases are coinciding with recent innovations in medical technology, which have been critical in not only preventing and managing them but also increasing the survival rate.

As medical technologies associated with the diagnosis and treatment of cardiovascular disease continue to evolve, medical technology companies provide an opportunity for investors to create wealth through health.

Keep reading...Show less

Thermo Fisher Scientific Reports First Quarter 2024 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the first quarter ended March 30, 2024.

First Quarter 2024 Highlights

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
March Quarterly Appendix 4C

March Quarterly Appendix 4C

Cardiex Limited (ASX:CDX) (Cardiex, the Company) has released its Quarterly Cash Flow Report.


Keep reading...Show less
Cardiex March 2024 Quarter Update

Cardiex March 2024 Quarter Update

Cardiex Limited (ASX:CDX) (Cardiex, the Company) is pleased to present its Quarterly Report.
Keep reading...Show less

Medtronic: Americans Favor Quality Over Quantity in Pursuit of Longevity

According to a new survey from Medtronic and Morning Consult, nearly two-thirds of U.S. adults say they'd opt for a shorter, healthier life than a longer one with health issues

Americans overwhelmingly say that when they think about longevity, it's more than just living longer - it's about living their healthiest, best lives. While most want to live to 90-well past the average U.S. life expectancy of 77.5 years-nearly two-thirds (66%) would choose a shorter, healthier life over a longer one with health issues. These findings, from a survey conducted by global healthcare technology leader Medtronic with Morning Consult, highlight a gap between U.S. adults' desire to live healthier years and the opportunity for more people to improve their quality of life through healthcare technology

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×