Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain

The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna™ spinal cord stimulation (SCS) system for the treatment of chronic pain
This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems ^§1,2,3

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) approval of the company's Eterna™ spinal cord stimulation (SCS) system the smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain.* 4 Eterna SCS utilizes Abbott's proprietary low-dose BurstDR™ stimulation, the only SCS waveform technology with the highest level of clinical evidence (1A evidence), proven to reduce pain 23% more than traditional waveform technology approaches. 5

Abbott developed Eterna based on extensive studies with patients, physicians and caregivers to understand the unmet needs of people living with chronic pain. The studies found that people wanted a smaller implant for comfort while reducing the need to charge the device daily or weekly. With patient needs front of mind, Abbott created Eterna to be recharged less than five times a year under normal use, making it the lowest recharge burden platform on the market. ^§1,2,3

Key features include:

Smallest device: Designed with daily comfort in mind ⁶ the Eterna SCS system is the smallest implantable, rechargeable spinal cord stimulator* ⁴ on the market.
Clinically proven therapy: The Eterna SCS system features Abbott's proprietary BurstDR stimulation, which mimics natural firing patterns found in the brain ⁷ to deliver superior** ⁸ pain relief. BurstDR stimulation is preferred to traditional "tingling" tonic stimulation by 87% of patients. ⁹
Lowest recharging requirements: Paired with Abbott's new Xtend™ energy technology, Eterna optimizes the patient charging experience, requiring as few as five recharges per year under standard use from a wireless charger. ^§^1,2,3
MRI capabilities: Eterna uses Abbott's TotalScan™ MRI technology, which allows for full-body MRI scans – a critical need of chronic pain patients who require accessibility to improved diagnostics and healthcare.
U pgradable platform: As Abbott continues to make advancements in SCS therapy, the Eterna SCS system can adapt to future innovations without replacing the implant.
iPhone integration: Abbott's patient-focused mobile app supports real-time battery life and charging status updates of the Eterna SCS system on a personal or Abbott-provided Apple device.

"Abbott's low-dose BurstDR stimulation is clinically proven to reduce pain, improve people's ability to perform everyday activities, and reduce emotional suffering associated with pain," ^{^8} said Timothy Deer , M.D., DABPM, president and chief executive officer of the Spine and Nerve Centers of the Virginias in Charleston, W.Va. "Until now, it wasn't available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds – a small, best-in-class rechargeable device with superior stimulation therapy."

More than 50 million people in the U.S. suffer from chronic pain. ¹⁰ According to the U.S. Pain Foundation, chronic pain is the leading cause of people going to the doctor and costs the nation approximately $635 billion each year in healthcare, disability and lost productivity costs. ¹¹ SCS, also known as neurostimulation, has been recommended by doctors for more than 50 years to help people manage chronic pain and improve their quality of life. Devices used for SCS consist of thin wires placed between the spinal cord and the vertebrae and a small implant placed under the skin in the lower back that helps disrupt pain signals before they can reach the brain.

"At Abbott, we deliver products and solutions with the goal of simplifying healthcare, improving clinical outcomes and providing people suffering from chronic pain with the best experience possible. As we progress on this commitment, Eterna is the next major leap forward," said Pedro Malha, vice president, neuromodulation, Abbott. "Eterna is the smallest rechargeable spinal cord stimulator on the market, provides the longest therapy between charges and offers an optimized recharging experience – all key features when selecting the best overall system."* ^§^3,4

Abbott's portfolio of neuromodulation devices also includes Proclaim™ XR, the recharge-free SCS system, and Proclaim Plus featuring FlexBurst360™, the SCS system that offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can be adjusted as a person's therapeutic needs evolve. All use the clinically proven low-dose BurstDR stimulation therapy.

* Smallest size determined by volume in cubic centimeters.
** BurstDR stimulation superiority when compared to traditional tonic stimulation as studied in SUBNURST.
^ Pain and suffering as measured by visual analog scale.
^§ Approximately one hour per month or three hours five times per year at standard (nominal) settings for BurstDR™ programs: 30/90 dosing when programmed with amplitude of 0.6mA and all other BurstDR™ settings are left at default compared to recommended charging frequency and duration of competitors. Recommended recharge frequency and duration for competitor product described in their respective IFU.

For U.S. important safety information on the Abbott Eterna spinal cord stimulation system, visit: https://bit.ly/3Wgpude .

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

¹ Abbott. Eterna IPG Battery Recharge Characterization Report (90903492); 2022.
² Abbott. Eterna IPG Elect Design Verification Report: Current Draw (90860050). 2022
³ Abbott. Eterna Lowest Recharge Burden Comparison Memo (MAT-2210739); 2022.
⁴ Abbott. Eterna SCS IPG Size Comparison Memo (MAT-2210151); 2022.
⁵ Karri J, Orhurhu V, Wahezi S, Tang T, Deer T, Abd-Elsayed A. Comparison of Spinal Cord Stimulation Waveforms for Treating Chronic Low Back Pain: Systematic Review and Meta-Analysis. Pain Physician. 2020 Sep;23(5):451-460. PMID: 32967388.
⁶ Baranidharan G, Bretherton B, Richert G, et al. Pocket pain, does location matter: a single-centre retrospective study of patients implanted with a spinal cord stimulator. Reg Anesth Pain Med. 2020.; 0:1-7. doi:10.1136/rapm-2020-101752
⁷ De Ridder D., Vanneste, S., Plazier, M., & Vancamp, T., (2015). Mimicking the Brain: Evaluation of St. Jude Medical's Prodigy Chronic Pain System with Burst Technology. Expert Review of Medical Devices, 12(2), 143-150.
⁸ Deer T, Slavin KV, Amirdelfan K, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2017;20(6):543-552.
⁹ Deer, T. Randomized, Controlled Trial Assessing Burst Stimulation for Chronic Pain: 2-Year Outcomes from the SUNBURST Study. Presented at NANS 2018.
¹⁰ Yong RJ, Mullins PM, Bhattacharyya N. Prevalence of chronic pain among adults in the United States . Pain. 2022 Feb 1 ;163(2):e328-e332.
¹¹ U.S. Pain Foundation. Chronic Pain Facts. https://uspainfoundation.org/pain/ . Accessed June 27, 2022 .

View original content: https://www.prnewswire.com/news-releases/abbott-launches-the-worlds-smallest-implantable-rechargeable-spinal-cord-stimulation-system-for-chronic-pain-301705855.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

Abbott Laboratories ABT Medical Device Investing

ABT

Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
The new programs build on a successful first year of the multi-million-dollar corporate initiative

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Aehr Test Systems Receives Orders of Over $2.3 million

Aehr Test Systems (NASDAQ:AEHR) has over 2,500 systems installed over the world that test optical and memory integrated circuits, semiconductors and reliability qualification equipment announced that it received over $2.3 million in orders for test and burn-in services. These orders came from a major manufacturer where Aehr’s services would be implemented for automotive products.

As quoted in the press release:

Keep reading...Show less

Cyclacel Reports Fourth Quarter And 2016 Financial Results

Cyclacel Pharmaceuticals (NASDAQ:CYCC) posted its financial results for the fourth quarter and full year 2016.
As quoted in the press release:

The Company’s net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.

Keep reading...Show less

Enanta Pharmaceuticals Announces AbbVie’s Investigational Regimen of Glecaprevir/Pibrentasvir Shows High SVR Rates

Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR₁₂) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR₁₂was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. These new data from the Phase 3 EXPEDITION-4 study, evaluating patients with chronic HCV infection across all major genotypes (GT1-6) and severe CKD, will be presented as a late-breaker today at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The EXPEDITION-4 results are the latest to be released from
registrational studies in AbbVie’s G/P clinical development program,
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing areas of continued
unmet need.
Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second
protease inhibitor being developed through its collaboration with
AbbVie. G/P is a once-daily regimen that combines two distinct antiviral
agents. G/P is a fixed-dose combination of glecaprevir (300mg) and
pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral
tablets.
HCV is common among people with severe CKD, reaching prevalence of up to
80 percent in some regions of the world.¹ In the U.S., it is
estimated that over 500,000 people have both chronic HCV and CKD².
Some chronic HCV infected patients with severe CKD, particularly those
with GT2 and GT3 HCV infection, currently don’t have access to
direct-acting antivirals (DAAs). The development of new, safe and
effective regimens to treat HCV in these patients remains a critical
unmet medical need.³
The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney
disease, including 85 patients (82 percent) who were receiving dialysis
at enrollment and 20 patients (19 percent) who had compensated
cirrhosis. The study also included those who were not cured with
previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with
interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
The majority of treatment related adverse events (AEs) were mild or
moderate. The most commonly reported AEs included pruritus, fatigue and
nausea. Of the 24 percent of patients who experienced serious AEs, none
were considered related to G/P. Four AEs (4 percent) led to the
discontinuation of G/P and one patient died after achieving SVR₄
due to a serious AE (intracerebral hemorrhage) considered not-related to
G/P.
*Patients who achieve a sustained virologic response at 12 weeks post
treatment (SVR₁₂) are considered cured of
hepatitis C
About the EXPEDITION-4 Study
EXPEDITION-4 is a single-arm,
open-label, Phase 3 study evaluating the safety and efficacy of 12 weeks
of G/P in patients with GT1-6 chronic HCV infection and chronic kidney
disease, including those on dialysis. The primary endpoint is SVR₁₂.
Patients in the study had severe or end stage kidney disease (stage 4
and 5 CKD), with an eGFR < 30 mL/min/1.73 m2 required at screening.
Prior treatment in the study is defined as treatment with interferon
(IFN)/pegIFN ± RBV, or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov/.
About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on four disease
targets: Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Non-alcoholic
Steatohepatitis (NASH) and Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with AbbVie, include paritaprevir, which
is contained in AbbVie’s marketed DAA regimens for HCV, and glecaprevir
(ABT-493), Enanta’s second protease inhibitor product, which AbbVie has
developed in Phase 3 studies in a fixed-dose combination (G/P) with
pibrentasvir (ABT-530), AbbVie’s second NS5A inhibitor, and is preparing
for regulatory approval filings in the U.S., Europe and Japan.
Enanta has also discovered EDP-305, an FXR agonist product candidate for
NASH, currently in Phase 1 clinical development, as well as a
cyclophilin inhibitor, EDP-494, a novel host-targeting mechanism for
HCV, which is also in Phase 1 clinical development. In addition, Enanta
has early lead candidates for HBV and RSV in preclinical development.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s investigational
HCV treatment regimen containing glecaprevir (ABT-493). Statements that
are not historical facts are based on management’s current expectations,
estimates, forecasts and projections about Enanta’s business and the
industry in which it operates and management’s beliefs and assumptions.
The statements contained in this release are not guarantees of future
performance and involve certain risks, uncertainties and assumptions,
which are difficult to predict. Therefore, actual outcomes and results
may differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual results
include: the efforts of AbbVie (our collaborator developing glecaprevir)
to develop its glecaprevir/pibrentasvir(G/P) combination and
successfully obtain regulatory approval and commercialize it; the
regulatory and marketing efforts of others with respect to competitive
treatment regimens for HCV; regulatory and reimbursement actions
affecting G/P, any competitive regimen, or both; the need to obtain and
maintain patent protection for glecaprevir and avoid potential
infringement of the intellectual property rights of others; and other
risk factors described or referred to in “Risk Factors” in Enanta’s most
recent Form 10-K for the fiscal year ended September 30, 2015 and other
periodic reports filed more recently with the Securities and Exchange
Commission. Enanta cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this release, and Enanta undertakes no
obligation to update or revise these statements, except as may be
required by law.
________________________________________________
¹ Fabrizi F, Poordad FF, Martin P. Hepatitis C infection in
the patient with end stage renal disease. Hepatology. 2002;36(1):3-10.
² IMS Health, July 2016. Parsippany, NJ; Medivo, July 2016.
New York, NY (Estimate based on IMS Health Dx Medical Claims
12/2013-4/2016; IMS Health Life Link Patient Level Data 12/2013-4/2016;
Medivo Lab Data 12/2013-4/2016).
³ American Association for the Study of Liver Diseases.
Recommendations for Testing, Managing, and Treating Hepatitis C,
February 24, 2016, https://www.hcvguidelines.org/full-report/monitoring-patients-who-are-starting-hepatitis-c-treatment-are-treatment-or-have.
Accessed March 15, 2016.

Artificial Intelligence Reshaping Healthcare Industry with Unimaginable Potential

FN Media Group News Commentary - The Healthcare Artificial Intelligence (AI) market exhibits a high degree of innovation, characterized by ongoing advancements in technology. Rapid developments in ML, deep learning, NLP, and computer vision are driving the evolution of AI-powered healthcare solutions. One primary factor driving market growth is the increasing demand in the healthcare sector for enhanced efficiency, accuracy, and better patient outcomes. According to a March 2024 Microsoft-IDC study, 79% of healthcare organizations are presently utilizing AI technology. In addition, the return on investment (ROI) is realized within 14 months, generating USD 3.20 for every USD 1 invested in artificial intelligence (AI). AI technologies hold transformative potential in various areas including medical imaging analysis, predictive analytics, personalized treatment planning, and drug discovery, potentially transforming conventional healthcare practices. A report from Grand View Research said the global AI in healthcare market size, which was estimated at USD 19.27 billion in 2023, is expected to grow at a CAGR of 38.5% from 2024 to 2030. The report said: "Mergers & acquisitions (M&As) play a significant role in shaping the healthcare AI market landscape. Companies [that] engage in M&A activities to expand their AI software and services increase their market reach or acquire specialized technology and expertise. End-users are becoming increasingly aware of the potential benefits of AI in improving patient care, operational efficiency, and healthcare outcomes. Education initiatives and industry events helped raise awareness about the capabilities and applications of AI in healthcare." A.I. companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Teladoc Health, Inc. (NYSE: TDOC), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Clover Health Investments, Corp. (NASDAQ: CLOV).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Medtronic receives FDA clearance for new InPen app, paving the way for its Smart MDI system launch with Simplera CGM

New Smart MDI system will be the first system to deliver real-time, personalized insights on when and how much to dose including for missed or inaccurate mealtime doses.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM). The company's Smart MDI system combines its InPen™ smart insulin pen with its newest Simplera™ CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Knight Therapeutics Announces Health Canada Approval for JORNAY PM to Treat Attention-Deficit Hyperactivity Disorder

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved JORNAY PM ™, an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children.

JORNAY PM ™ is the first and only evening-dosed methylphenidate product commercially available in Canada to treat ADHD in patients from 6 to 12 years of age. JORNAY PM ™ consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient starting in the morning and continuing throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until the evening.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

Gold Investing

Contacts:
Janet Cho	Ryan Weispfenning
Public Relations	Investor Relations
+1-818-403-7028	+1-763-505-4626

MEDTRONIC PLC WORLD WIDE REVENUE ⁽¹⁾ (Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 3,102	$ 2,923	6.1 %	$ 16	$ 3,086	$ 2,923	5.6 %	$ 6,108	$ 5,773	5.8 %	$ (23)	$ 6,132	$ 5,773	6.2 %
Cardiac Rhythm & Heart Failure	1,578	1,492	5.8	11	1,567	1,492	5.0	3,114	2,938	6.0	(8)	3,122	2,938	6.2
Structural Heart & Aortic	881	819	7.6	4	877	819	7.1	1,736	1,633	6.3	(8)	1,744	1,633	6.8
Coronary & Peripheral Vascular	643	613	4.9	1	642	613	4.8	1,259	1,202	4.7	(7)	1,266	1,202	5.3
Neuroscience	2,451	2,288	7.1	10	2,441	2,288	6.7	4,768	4,506	5.8	(8)	4,776	4,506	6.0
Cranial & Spinal Technologies	1,234	1,157	6.7	3	1,231	1,157	6.4	2,382	2,260	5.4	(6)	2,387	2,260	5.6
Specialty Therapies	737	705	4.6	5	732	705	3.9	1,450	1,400	3.5	(2)	1,452	1,400	3.7
Neuromodulation	480	426	12.6	2	478	426	12.1	937	846	10.8	(1)	938	846	10.9
Medical Surgical	2,128	2,103	1.2	10	2,117	2,103	0.7	4,123	4,107	0.4	(18)	4,142	4,107	0.8
Surgical & Endoscopy	1,649	1,641	0.5	9	1,641	1,641	—	3,193	3,187	0.2	(13)	3,207	3,187	0.6
Acute Care & Monitoring	478	462	3.6	1	477	462	3.3	930	921	1.0	(5)	935	921	1.6
Diabetes	686	610	12.4	9	678	610	11.0	1,333	1,189	12.1	5	1,329	1,189	11.8
Total Reportable Segments	8,366	7,923	5.6	45	8,322	7,923	5.0	16,333	15,575	4.9	(46)	16,379	15,575	5.2
Other ⁽²⁾	37	61	(38.9)	—	—	—	—	(15)	111	(113.5)	(2)	—	—	—
TOTAL	$ 8,403	$ 7,984	5.3 %	$ 45	$ 8,322	$ 7,923	5.0 %	$ 16,318	$ 15,686	4.0 %	$ (48)	$ 16,379	$ 15,575	5.2 %


(1)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.
(2)	Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the three months ended July 26, 2024, impacting year-to-date figures, $90 million of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015.
(3)	The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
(4)	The three months ended October 25, 2024 includes $82 million of revenue adjustments related to $37 million of inorganic revenue for the transition activity noted in (2) and $45 million of favorable currency impact on the remaining segments. The three months ended October 27, 2023 excludes $61 million of inorganic revenue related to the transition activity noted in (2).
(5)	The six months ended October 25, 2024 excludes $61 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $75 million of inorganic revenue related to the transition activity noted in (2), and $46 million of unfavorable currency impact on the remaining segments. The six months ended October 27, 2023 excludes $111 million of inorganic revenue related to the transition activity noted in (2).

MEDTRONIC PLC U.S. ⁽¹⁾⁽²⁾ REVENUE (Unaudited)

	SECOND QUARTER						YEAR-TO-DATE
	REPORTED			ORGANIC			REPORTED			ORGANIC
(in millions)	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth	FY25	FY24	Growth	Adjusted FY25	Adjusted FY24	Growth
Cardiovascular	$ 1,434	$ 1,427	0.5 %	$ 1,434	$ 1,427	0.5 %	$ 2,836	$ 2,776	2.2 %	$ 2,836	$ 2,776	2.2 %
Cardiac Rhythm & Heart Failure	768	782	(1.8)	768	782	(1.8)	1,534	1,502	2.1	1,534	1,502	2.1
Structural Heart & Aortic	388	367	5.7	388	367	5.7	757	724	4.5	757	724	4.5
Coronary & Peripheral Vascular	278	278	0.1	278	278	0.1	546	550	(0.8)	546	550	(0.8)
Neuroscience	1,677	1,560	7.5	1,677	1,560	7.5	3,242	3,057	6.0	3,242	3,057	6.0
Cranial & Spinal Technologies	926	863	7.2	926	863	7.2	1,781	1,685	5.7	1,781	1,685	5.7
Specialty Therapies	418	403	3.6	418	403	3.6	816	795	2.6	816	795	2.6
Neuromodulation	333	293	13.7	333	293	13.7	645	577	11.8	645	577	11.8
Medical Surgical	944	948	(0.4)	944	948	(0.4)	1,825	1,815	0.5	1,825	1,815	0.5
Surgical & Endoscopy	675	688	(1.9)	675	688	(1.9)	1,304	1,308	(0.2)	1,304	1,308	(0.2)
Acute Care & Monitoring	269	260	3.6	269	260	3.6	521	508	2.6	521	508	2.6
Diabetes	232	217	6.9	232	217	6.9	447	405	10.4	447	405	10.4
Total Reportable Segments	4,286	4,151	3.3	4,286	4,151	3.3	8,350	8,054	3.7	8,350	8,054	3.7
Other ⁽³⁾	18	23	(22.2)	—	—	—	37	45	(19.0)	—	—	—
TOTAL	$ 4,304	$ 4,175	3.1 %	$ 4,286	$ 4,151	3.3 %	$ 8,387	$ 8,099	3.6 %	$ 8,350	$ 8,054	3.7 %


(1)	U.S. includes the United States and U.S. territories.
(2)	The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely.
(3)	Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested.

MEDTRONIC PLC INTERNATIONAL REVENUE ⁽¹⁾ (Unaudited)

	SECOND QUARTER							YEAR-TO-DATE
	REPORTED				ORGANIC			REPORTED				ORGANIC
(in millions)	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁴⁾	Adjusted FY24 ⁽⁴⁾	Growth	FY25	FY24	Growth	Currency Impact ⁽³⁾	Adjusted FY25 ⁽⁵⁾	Adjusted FY24 ⁽⁵⁾	Growth
Cardiovascular	$ 1,668	$ 1,496	11.5 %	$ 16	$ 1,652	$ 1,496	10.4 %	$ 3,272	$ 2,996	9.2 %	$ (23)	$ 3,295	$ 2,996	10.0 %
Cardiac Rhythm & Heart Failure	811	710	14.2	11	799	710	12.6	1,580	1,436	10.0	(8)	1,588	1,436	10.6
Structural Heart & Aortic	492	451	9.1	4	488	451	8.3	980	909	7.8	(8)	988	909	8.7
Coronary & Peripheral Vascular	365	335	8.9	1	364	335	8.7	713	652	9.3	(7)	720	652	10.4
Neuroscience	774	728	6.3	10	764	728	5.0	1,526	1,449	5.3	(8)	1,535	1,449	5.9
Cranial & Spinal Technologies	308	293	5.0	3	305	293	3.9	600	576	4.2	(6)	606	576	5.2
Specialty Therapies	319	302	5.8	5	315	302	4.3	634	605	4.8	(2)	636	605	5.1
Neuromodulation	146	133	10.4	2	144	133	8.8	292	269	8.8	(1)	293	269	9.1
Medical Surgical	1,183	1,155	2.5	10	1,173	1,155	1.6	2,298	2,292	0.3	(18)	2,317	2,292	1.1
Surgical & Endoscopy	974	953	2.3	9	966	953	1.4	1,889	1,879	0.5	(13)	1,902	1,879	1.2
Acute Care & Monitoring	209	202	3.5	1	208	202	2.8	409	413	(0.9)	(5)	414	413	0.4
Diabetes	455	394	15.5	9	446	394	13.2	886	784	13.1	5	882	784	12.5
Total Reportable Segments	4,080	3,772	8.2	45	4,035	3,772	7.0	7,983	7,521	6.1	(46)	8,028	7,521	6.7
Other ⁽²⁾	19	37	(49.4)	—	—	—	—	(51)	66	(178.3)	(2)	—	—	—
TOTAL	$ 4,099	$ 3,809	7.6 %	$ 45	$ 4,035	$ 3,772	7.0 %	$ 7,931	$ 7,587	4.5 %	$ (48)	$ 8,028	$ 7,521	6.7 %

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited)

	Three months ended		Six months ended
(in millions, except per share data)	October 25, 2024	October 27, 2023	October 25, 2024	October 27, 2023
Net sales	$ 8,403	$ 7,984	$ 16,318	$ 15,686
Costs and expenses:
Cost of products sold, excluding amortization of intangible assets	2,946	2,761	5,707	5,390
Research and development expense	697	698	1,373	1,365
Selling, general, and administrative expense	2,757	2,686	5,412	5,299
Amortization of intangible assets	413	425	827	855
Restructuring charges, net	30	40	77	94
Certain litigation charges, net	—	65	81	105
Other operating income, net	(34)	(31)	(33)	(30)
Operating profit	1,595	1,340	2,873	2,608
Other non-operating income, net	(173)	(154)	(330)	(230)
Interest expense, net	209	180	376	329
Income before income taxes	1,559	1,313	2,827	2,510
Income tax provision	281	402	500	802
Net income	1,278	911	2,327	1,708
Net income attributable to noncontrolling interests	(9)	(2)	(15)	(8)
Net income attributable to Medtronic	$ 1,270	$ 909	$ 2,312	$ 1,700
Basic earnings per share	$ 0.99	$ 0.68	$ 1.79	$ 1.28
Diluted earnings per share	$ 0.99	$ 0.68	$ 1.79	$ 1.28
Basic weighted average shares outstanding	1,282.4	1,330.2	1,288.6	1,330.3

Diluted weighted average shares outstanding	1,286.9	1,331.9	1,292.5	1,332.8

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾ (Unaudited)

	Three months ended October 25, 2024
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 8,403	$ 2,946	64.9 %	$ 1,595	19.0 %	$ 1,559	$ 1,270	$ 0.99	18.0 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	413	4.9	413	338	0.26	18.2
Restructuring and associated costs ⁽²⁾	—	(11)	0.1	46	0.5	46	37	0.03	19.6
Acquisition and divestiture-related items ⁽³⁾	—	(5)	0.1	(25)	(0.3)	(25)	(30)	(0.02)	(20.0)
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	(10)	(21)	(0.02)	(100.0)
Medical device regulations ⁽⁵⁾	—	(9)	0.1	12	0.1	12	10	0.01	16.7
Certain tax adjustments, net	—	—	—	—	—	—	16	0.01	—
Non-GAAP	$ 8,403	$ 2,921	65.2 %	$ 2,041	24.3 %	$ 1,995	$ 1,620	$ 1.26	18.3 %
Currency impact	(45)	(103)	1.1	145	1.9			0.09
Currency Adjusted	$ 8,358	$ 2,818	66.3 %	$ 2,186	26.2 %			$ 1.35

	Three months ended October 27, 2023
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 7,984	$ 2,761	65.4 %	$ 1,340	16.8 %	$ 1,313	$ 909	$ 0.68	30.6 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	425	5.3	425	360	0.27	15.3
Restructuring and associated costs ⁽²⁾	—	(15)	0.2	91	1.1	91	76	0.06	17.6
Acquisition and divestiture-related items ⁽³⁾	—	(6)	0.1	58	0.7	58	51	0.04	12.1
Certain litigation charges, net	—	—	—	65	0.8	65	50	0.04	23.1
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	25	21	0.02	20.0
Medical device regulations ⁽⁵⁾	—	(21)	0.3	30	0.4	30	24	0.02	20.0
Certain tax adjustments, net ⁽⁶⁾	—	—	—	—	—	—	176	0.13	—
Non-GAAP	$ 7,984	$ 2,720	65.9 %	$ 2,009	25.2 %	$ 2,008	$ 1,667	$ 1.25	16.9 %


See description of non-GAAP financial measures contained in the press release dated November 19, 2024.
(1)	The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.
(2)	Associated costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs.
(3)	The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business-related charges. The three months ended October 25, 2024, also include gains related to certain business or asset sales.
(4)	We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
(5)	The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.
(6)	The charge primarily relates to the establishment of a valuation allowance against certain net operating losses.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS ⁽¹⁾ (Unaudited)

	Six months ended October 25, 2024
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 16,318	$ 5,707	65.0 %	$ 2,873	17.6 %	$ 2,827	$ 2,312	$ 1.79	17.7 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	827	4.9	827	678	0.52	18.0
Restructuring and associated costs ⁽²⁾	—	(20)	0.1	108	0.6	108	87	0.07	19.4
Acquisition and divestiture-related items ⁽³⁾	—	(16)	0.1	(13)	(0.1)	(13)	(19)	(0.01)	(46.2)
Certain litigation charges, net	—	—	—	81	0.5	81	68	0.05	16.0
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	(27)	(38)	(0.03)	(37.0)
Medical device regulations ⁽⁵⁾	—	(20)	0.1	27	0.2	27	22	0.02	18.5
Other ⁽⁶⁾	90	—	0.4	90	0.5	90	70	0.05	22.2
Certain tax adjustments, net	—	—	—	—	—	—	33	0.03	—
Non-GAAP	$ 16,408	$ 5,651	65.6 %	$ 3,993	24.3 %	$ 3,921	$ 3,213	$ 2.49	17.7 %
Currency impact	46	(134)	0.9	246	1.5			0.16
Currency Adjusted	$ 16,454	$ 5,517	66.5 %	$ 4,239	25.8 %			$ 2.65

	Six months ended October 27, 2023
(in millions, except per share data)	Net Sales	Cost of Products Sold	Gross Margin Percent	Operating Profit	Operating Profit Percent	Income Before Income Taxes	Net Income attributable to Medtronic	Diluted EPS	Effective Tax Rate
GAAP	$ 15,686	$ 5,390	65.6 %	$ 2,608	16.6 %	$ 2,510	$ 1,700	$ 1.28	32.0 %
Non-GAAP Adjustments:
Amortization of intangible assets	—	—	—	855	5.5	855	724	0.54	15.2
Restructuring and associated costs ⁽²⁾	—	(30)	0.2	182	1.2	182	152	0.11	16.5
Acquisition and divestiture-related items ⁽³⁾	—	(12)	0.1	107	0.7	107	97	0.07	9.3
Certain litigation charges, net	—	—	—	105	0.7	105	81	0.06	22.9
(Gain)/loss on minority investments ⁽⁴⁾	—	—	—	—	—	89	85	0.06	5.6
Medical device regulations ⁽⁵⁾	—	(42)	0.3	62	0.4	62	49	0.04	21.0
Certain tax adjustments, net ⁽⁷⁾	—	—	—	—	—	—	375	0.28	—
Non-GAAP	$ 15,686	$ 5,306	66.2 %	$ 3,919	25.0 %	$ 3,910	$ 3,262	$ 2.45	16.4 %


See description of non-GAAP financial measures contained in the press release dated November 19, 2024.
(1)	The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.
(2)	Free cash flow represents operating cash flows less property, plant, and equipment additions.

MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited)

(in millions)	October 25, 2024	April 26, 2024
ASSETS
Current assets:
Cash and cash equivalents	$ 1,394	$ 1,284
Investments	6,595	6,721
Accounts receivable, less allowances and credit losses of $195 and $173, respectively	6,260	6,128
Inventories	5,479	5,217
Other current assets	2,710	2,584
Total current assets	22,438	21,935
Property, plant, and equipment, net	6,438	6,131
Goodwill	41,161	40,986
Other intangible assets, net	12,423	13,225
Tax assets	3,572	3,657
Other assets	4,009	4,047
Total assets	$ 90,042	$ 89,981
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations	$ 3,719	$ 1,092
Accounts payable	2,376	2,410
Accrued compensation	1,893	2,375
Accrued income taxes	947	1,330
Other accrued expenses	3,260	3,582
Total current liabilities	12,195	10,789
Long-term debt	24,607	23,932
Accrued compensation and retirement benefits	1,084	1,101
Accrued income taxes	1,432	1,859
Deferred tax liabilities	473	515
Other liabilities	1,534	1,365
Total liabilities	41,326	39,561
Commitments and contingencies
Shareholders' equity:
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,553,150 and 1,311,337,531 shares issued and outstanding, respectively	—	—
Additional paid-in capital	20,824	23,129
Retained earnings	30,919	30,403
Accumulated other comprehensive loss	(3,250)	(3,318)
Total shareholders' equity	48,494	50,214
Noncontrolling interests	222	206
Total equity	48,716	50,420
Total liabilities and equity	$ 90,042	$ 89,981

Contacts:

Erika Winkels	Ryan Weispfenning
Public Relations	Investor Relations
+1-763-526-8478	+1-763-505-4626

Investor Contact:
Knight Therapeutics Inc.
Samira Sakhia	Arvind Utchanah
President & Chief Executive Officer	Chief Financial Officer
T: 514.484.4483	T. +598.2626.2344
F: 514.481.4116
Email: IR@knighttx.com	Email: IR@knighttx.com
Website: www.knighttx.com	Website: www.knighttx.com

Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain

Latest News

Latest Press Releases

Related News

TOP STOCKS