Economic Analysis Finds Continuous Monitoring for Respiratory Depression May Provide Benefits to Patients and Reduce Hospital Costs

Economic Model Based on PRODIGY Trial Data Demonstrates Continuous Pulse Oximetry and Capnography Monitoring of High-Risk Patients May Reduce Hospital Costs by Over $500,000 Annually

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the publication of an economic model based on data from the PRODIGY trial (PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY) that demonstrates shorter patient stays and reduced hospital costs associated with continuous pulse oximetry and capnography monitoring for patients receiving opioids on medical-surgical units when compared to intermittent pulse oximetry alone. According to study findings, continuous capnography and pulse oximetry monitoring of high-risk patients who are receiving opioids could result in $535,531 annual hospital cost savings for a median-sized U.S. hospital and a cumulative patient length of stay decrease of 103 days per year, assuming respiratory depression is decreased by 20%.

Pulse oximetry is a simple, noninvasive bedside technology that can accurately measure changes in arterial blood oxygen saturation and pulse rate. Capnography measures exhaled carbon dioxide during the respiration cycle as well as respiratory rate.

Published online in the May 2021 issue of Advances in Therapy   , the analysis was based primarily on data from the PRODIGY trial. PRODIGY is a Medtronic-sponsored, prospective observational, multi-center study conducted to quantify the incidence of and identify patients at high risk for opioid-induced respiratory depression (OIRD), a potentially life-threatening form of respiratory compromise (RC) that reduces the patient's drive to breathe.

"Although respiratory depression occurs in 46% of patients receiving opioids on the general care floor, the cost-benefit of capnography and oximetry for continuous monitoring of patients had not yet been examined," said Ashish K. Khanna , M.D., primary study investigator and an associate professor of Anesthesiology, vice-chair for Research, and intensivist at the Wake Forest School of Medicine. "Our findings suggest that compared to intermittent monitoring, investing in continuous monitoring of high-risk patients receiving opioids could reduce the cost burden and length of patient stay while potentially increasing patient safety. Our model suggests that a mere reduction of 1.5% in the incidence of respiratory depression would allow hospital systems to recover costs associated with the investment in monitoring. The expected reduction from deployment of continuous monitoring on hospital floors is way more."

The economic model was designed using a decision tree framework simulating costs and outcomes of continuous Nellcor™ pulse oximetry and Microstream™ capnography monitoring* versus intermittent pulse oximetry monitoring* for patients at high risk, high and intermediate risk, and any risk of respiratory depression based on their PRODIGY score . Patients' PRODIGY score was derived from five independent patient characteristics — age, gender, sleep-disordered breathing, opioid naivety, and chronic heart failure. The model applied the results of the PRODIGY study to a hypothetical median-sized U.S. hospital with 2,447 patients receiving opioids on a medical surgical floor in a given year.

"Respiratory compromise is a common, costly, potentially deadly — and preventable — condition. RC is a leading cause of ICU admissions and is one of the key contributing factors for code blues, 1 , 2 " said Frank Chan , president of the Patient Monitoring business, which is part of the Medical Surgical Portfolio at Medtronic. "Medtronic has a deep-rooted history of discovering, developing, and commercializing transformative treatment options for patients globally. As RC continues to be studied, we are able to analyze these learnings and design innovative solutions to help physicians better care for their patients who may experience OIRD."

Additionally, the primary objective of the PRODIGY trial was to develop and validate a risk stratification tool to assist clinicians in the identification of high risk patients receiving opioids. 3 The PRODIGY risk stratification tool may support the recent updates from The Joint Commission on monitoring of post-operative patients receiving opioids with the requirement of putting in place a mechanism to identify high risk patients. 4

For additional information about the PRODIGY clinical trial, please visit: medtronic.com/prodigy .

About Respiratory Compromise
Respiratory compromise is a potentially life-threatening, progressive condition negatively impacting a person's ability to breathe adequately to maintain oxygenation and carbon dioxide removal. Patients with respiratory depression may experience shallow, slow, or no breathing after opioid administration which undetected can lead to cardiopulmonary arrest and death. 5 This condition is rapidly becoming the third-most costly hospital inpatient expense in the U.S., and dramatically increases the likelihood of adverse patient outcomes and cost of patient care. 6 Not only is respiratory compromise common and dangerous, it has been very difficult to predict. 7 , 8 , 9

About the Patient Monitoring Operating Unit at Medtronic
The Patient Monitoring business at Medtronic is working together with the global healthcare community to solve clinically meaningful problems, with technologies and solutions for blood oxygen management, respiratory compromise, and perioperative complications.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services, and solutions companies – alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

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.

Pulse oximetry and capnography monitoring systems should not be used as the sole basis for diagnosis or therapy and are intended only as an adjunct in patient assessment.

* Continuous pulse oximetry and capnography device pricing assumptions used list pricing for the following: a Capnostreamâ„¢ portable respiratory monitor prorated over 7 years; a Microstreamâ„¢ capnography filterline, and a disposable Nellcorâ„¢ pulse oximetry sensor, resulting in $52.73 in device costs per continuously monitored patient stay on a medical surgical floor. For intermittent pulse oximetry monitoring, device pricing consisted of a multiparameter monitor prorated over 7 years and a reusable pulse oximetry sensor, resulting in $0.68 in device costs per patient stay. Additional information on pricing and assumptions are available in the study publication.

1 Schein RM, Hazday N, Pena M, Ruben BH, Sprung CL. Clinical antecedents to in-hospital cardiopulmonary arrest. Chest. 1990; 98(6):1388–1392.
2 Fecho K, Jackson F, Smith F, OverdykF. In-hospital resuscitation: opioids and other factors influencing survival. Ther Clin Risk Manag . 2009;5:961–968.
3 Khanna AK, Bergese S, Jungquist CR, et al. Prediction of opioid-induced respiratory depression on inpatient wards using continuous capnography and oximetry: an international prospective, observational trial. Anesth Analg. 2020;131:1012-1024.
4 https://www.jointcommission.org/standards/standard-faqs/hospital-and-hospital-clinics/leadership-ld/000002161/
5 Morris TA, Gay PC, MacIntyre NR, et al. Respiratory compromise as a new paradigm for the care of vulnerable hospitalized patients. Respir Care. 2017 Apr;62(4):497-512. doi: 10.4187/respcare.05021.
6 Wier LM, Henke R, Friedman B. Diagnostic groups with rapidly iCosts, by payer, 2001-2007: statistical brief #91. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville MD ; June 2010 .
7 Belcher AW, Khanna AK, Leung S, et al. Long-acting patient-controlled opioids are not associated with more postoperative hypoxemia than short-acting patient-controlled opioids after noncardiac surgery: a cohort analysis. Anesth Analg. 2016;123(6):1471-9.
8 Khanna AK, Sessler DI, Sun Z, et al. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Brit J Anaesth. 2016;116(5):632-40.
9 Sun Z, Sessler DI, Dalton JE, et al. Postoperative hypoxemia is common and persistent: a prospective blinded observational study. Anesth Analg. 2015;121(3):709-15.

Contacts:


Kira Jastive


Ryan Weispfenning

Public Relations


Investor Relations

+1-508-452-4238


+1-763-505-4626

Medtronic plc (PRNewsfoto/Medtronic plc)

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Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360â„¢ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9â„¢ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Afferaâ„¢ family of technologies, including the next-generation Sphere-360â„¢ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9â„¢ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelectâ„¢ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , 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 95,000+ 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 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. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

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Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugoâ„¢ robotic-assisted surgery (RAS) system.

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMedâ„¢ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuardâ„¢ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , 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 95,000+ 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 LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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