SMART trial one-year data demonstrates Medtronic Evolut TAVR platform as optimal treatment for severe aortic stenosis in patients with small annulus, which is primarily women

New data from largest head-to-head randomized control TAVR trial demonstrates non-inferior clinical outcomes and superior valve performance for Evolut TAVR compared to Sapien™ at one year

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced new data from the largest head-to-head comparative trial of transfemoral transcatheter aortic valve replacement (TAVR), were presented as a late breaking clinical trial at the American College of Cardiology Annual Scientific Session and simultaneously published in The New England Journal of Medicine . The one-year results of the SM all A nnuli R andomized T o Evolut or SAPIEN (SMART) Trial in individuals with aortic stenosis (AS) with small aortic annuli (SAA) demonstrated noninferior clinical outcomes and superior valve performance as measured by bioprosthetic valve dysfunction performance for the Evolut™ TAVR platform compared to the SAPIEN™ platform.

"SMART was launched to better understand how the two most commonly used TAVR systems perform in patients with small aortic annuli, and particularly in women who tend to have smaller heart valves," said Nina Goodheart , senior vice president and president, Structural Heart & Aortic, which is part of the Cardiovascular Portfolio at Medtronic. "We continue to develop evidence to better understand the benefits of our Evolut TAVR technology in all patients, including patient populations that are underrepresented, under-diagnosed and under-treated. The results from the SMART trial demonstrate these benefits in a large patient population and reinforce our commitment to driving health equity and engineering the best technology to solve unmet patient needs."

In addition to being the largest comparative trial of TAVR, SMART is also the largest TAVR trial to date to enroll primarily women (87%). Symptomatic severe aortic stenosis can be fatal if left untreated and the average patient survival is two years without treatment. 1 Despite women's longer life expectancy, once impacted by severe aortic stenosis they suffer from higher mortality than men, even after matching for age. 2 Both TAVR and surgical aortic valve replacement (SAVR) are options for women to treat AS. Due to their smaller aortic annuli, women can often receive a valve replacement that does not properly fit their anatomy — highlighting the need for clinical evidence to inform the best treatment approaches. 3 Additionally, despite prevalence of chronic conditions associated with AS in women over 65, a new survey of over 1,000 women announced today found that the majority have never been referred to a cardiologist.

"As clinicians, we know that tailored approaches are needed to address the unique presentation of AS in the small annulus patient population, which is primarily women. Little comparative data exists to help us with valve selection," said Howard C. Herrmann , M.D., Perelman School of Medicine at the University of Pennsylvania , Philadelphia, Penn. , and lead investigator of the SMART Trial. "While we know women have a greater benefit than men when treated with TAVR vs SAVR, now for the first time there is definitive data demonstrating that women have the best valve performance when treated with the Evolut TAVR system."

The SMART Trial is an international, prospective, multi-center, randomized (1:1) post-market trial comparing the safety and performance of self-expanding versus balloon-expandable TAVR in patients with symptomatic severe AS and SAA. The trial randomized and treated 716 patients, 87% of which were women, across more than 80 sites worldwide. Eligible patients had a computed tomography aortic valve annulus area of ≤430 mm 2 and suitable anatomy for transfemoral TAVR with both an Evolut PRO/PRO+/FX or a SAPIEN 3™/3 Ultra™ valve.

"For patients with heart valve replacements, early bioprosthetic valve dysfunction can lead to increased risk of serious long term outcomes including mortality and rehospitalization," added Dr. Herrmann. "As clinicians, these data further reinforces that not all valves are the same, and we strongly need to consider valve performance when determining device selection."

Results demonstrated that the Evolut TAVR platform met both co-primary endpoints of clinical non-inferiority and hemodynamic superiority at one year.

  • Evolut TAVR met non-inferiority for the clinical outcome primary endpoint, a composite of all-cause mortality, disabling stroke, or heart failure rehospitalization at one year (9.4% Evolut vs. 10.6% SAPIEN, p
  • Evolut TAVR demonstrated superiority for the valve function primary endpoint, bioprosthetic valve dysfunction through one year (9.4% Evolut vs. 41.6% SAPIEN, p

"Medtronic is committed to providing clinicians and patients with aortic stenosis long-term data to help to inform their treatment decisions," said Jeffrey Popma , M.D., vice president and Chief Medical Officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business at Medtronic. "Our prior studies have shown an important link between valve performance, mortality, and re-hospitalization at five years. All SMART patients will be followed for five years to assess the relationship between better valve performance and improved clinical outcomes in patients with small annuli."

Analyst and Investor Briefing  

Medtronic will host an analyst and investor briefing to discuss the results from the SMART Trial on Sunday, April 7, 2024, at 10:45 AM EDT. The briefing will feature remarks from Medtronic management, immediately followed by answering questions from institutional investors and equity analysts. A live, listen-only webcast will be available and can be accessed by clicking on the Events link at investorrelations.medtronic.com on April 7. An archived replay will be available on the same webpage later in the day. This event is not part of the official ACC Scientific Sessions.

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 95,000+ passionate people across 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.

SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation.

1 Carabello BA, Paulus WJ. Aortic stenosis. Lancet. March 14, 2009 ;373(9667):956-966.

2 Am Heart Assoc. 2021;10:e018816. DOI: 10.1161/JAHA.120.018816.

3 Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. April 1998 ;113(4):1109-1114

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

Kimberly Powell
Public Relations
+1-202-498-2601

(PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/smart-trial-one-year-data-demonstrates-medtronic-evolut-tavr-platform-as-optimal-treatment-for-severe-aortic-stenosis-in-patients-with-small-annulus-which-is-primarily-women-302109869.html

SOURCE Medtronic plc

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/07/c5818.html

News Provided by Canada Newswire via QuoteMedia

MDT
The Conversation (0)
Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. (TSX: PNE) ("Pine Cliff" or the "Company") announces its first quarter 2024 financial and operating results, an operational update and information regarding the annual meeting of shareholders.

First Quarter 2024 Results

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Canadian Natural Resources Limited Announces 2024 First Quarter Results

Canadian Natural's (TSX: CNQ) (NYSE: CNQ) President, Scott Stauth, commented on the Company's first quarter results, "Canadian Natural is a world class company and during our 35 years of operations, we've delivered significant value, including recently reaching a position where, commencing in 2024, we are returning 100% of our free cash flow to our shareholders. Crude oil price forecasts have strengthened for the remainder of 2024, including improvements in West Texas Intermediate ("WTI"), Western Canadian Select ("WCS") and Synthetic Crude Oil ("SCO") pricing over those prices experienced in the first quarter of 2024, driving significant targeted free cash flow generation going forward.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. (TSX: PNE) (OTCQX: PIFYF) ("Pine Cliff" or the "Company") is pleased to announce the appointments of Mr. Daniel Keenan P. Eng to the position of Vice President Exploitation and Mr. Austin Nieuwdorp CA, CPA to the position of Vice President Finance and Controller both effective May 1, 2024.

Mr. Keenan became part of Pine Cliff in 2016. He holds a Bachelor of Mechanical Engineering Degree from the University of Victoria obtained in 2001. Throughout his 20-year career, he has taken on increasingly challenging roles in exploitation, production operations and facilities engineering, culminating in his most recent position as Pine Cliff's Manager of Exploitation. Notably, Mr. Keenan has played a pivotal role in identifying and expanding Pine Cliff's asset portfolio and drilling opportunities, showcasing his leadership and strategic vision.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. (TSX: ACO.X) (TSX: ACO.Y)

2024 ATCO AGM (CNW Group/ATCO Ltd.)

ATCO Ltd. (ATCO) will hold its 57th Annual General Meeting of share owners at 10 a.m. MDT on Wednesday , May 15, 2024. In addition to the formal business of the meeting, attendees will hear management's view of ATCO's full year 2023 and first quarter 2024 operational and financial performance.

At this year's meeting, members of the ATCO executive leadership team will also outline growth strategies and goals for ATCO Structures, ATCO EnPower and ATCO Energy Systems.

Attendees will hear from:

  • Nancy Southern , Chair & Chief Executive Officer
  • Katie Patrick , Executive Vice President, Chief Financial & Investment Officer
  • Adam Beattie , President, ATCO Structures
  • Bob Myles , Chief Operating Officer, ATCO EnPower
  • Wayne Stensby , Chief Operating Officer, ATCO Energy Systems

Share owners and interested parties can view the meeting virtually using Microsoft Teams via this link using a web browser (Chrome, Safari, Edge or Firefox) on a smartphone, tablet or computer. Using Internet Explorer is not recommended as it is no longer supported and may not function properly.

Attendees who are share owners or proxyholders wishing to vote their shares should review the information contained in the ATCO Management Proxy Circular dated March 11, 2024 , beginning on page one.

As a global enterprise ATCO Ltd. and its subsidiary and affiliate companies have approximately 20,000 employees and assets of $25 billion . ATCO is committed to future prosperity by working to meet the world's essential energy, housing, security and transportation challenges. ATCO Structures designs, builds and delivers products to service the essential need for housing and shelter around the globe. ATCO Frontec provides operational support services to government, defence and commercial clients. ATCO Energy Systems delivers essential energy for an evolving world through its electricity and natural gas transmission and distribution, and international operations. ATCO EnPower creates sustainable energy solutions in the areas of renewables, energy storage, industrial water and clean fuels. ATCO Australia develops, builds, owns and operates energy and infrastructure assets. ATCOenergy and Rümi provide retail electricity and natural gas services, home maintenance services and professional home advice that bring exceptional comfort, peace of mind and freedom to homeowners and customers. ATCO also has investments in ports and transportation logistics, the processing and marketing of fly ash, retail food services and commercial real estate. More information can be found at www.ATCO.com .

Investor & Analyst Inquiries:  
Colin Jackson
Senior Vice President, Finance, Treasury & Sustainability
Colin.Jackson@atco.com
(403) 808 2636

Media Inquiries:
Kurt Kadatz
Director, Corporate Communications
Kurt.Kadatz@atco.com
(587) 228 4571

SOURCE ATCO Ltd.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/29/c6613.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

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
Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed Receives FDA Breakthrough Device Designation for AVIM Therapy

  • Breakthrough Device Designation ("BDD") applies to an estimated U.S. population of over 7.7 million patients with uncontrolled hypertension and increased cardiovascular risk
  • BDD also encompasses pacemaker-indicated patients with uncontrolled hypertension who are the focus of the BACKBEAT global pivotal study Orchestra BioMed is currently enrolling in strategic collaboration with Medtronic, plc (NYSE: MDT)
  • BDD status provides accelerated FDA engagement and reviews for AVIM therapy; it also supports potential pathways to secure higher reimbursement for AVIM-enabled devices in the future

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) ("Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Device Designation ("BDD") for atrioventricular interval modulation ("AVIM") therapy.

Specifically, the BDD is for an implantable system (i.e., a pacemaker) to deliver AVIM therapy using conduction system pacing to reduce blood pressure in patients with increased ten-year atherosclerotic cardiovascular disease ("ASCVD") risk, preserved left ventricular systolic function, and uncontrolled hypertension, despite the use of anti-hypertensive medications or in patients who may have intolerance to anti-hypertensive medications. Orchestra BioMed estimates that there are over 7.7 million patients in the U.S. that meet the criteria for the BDD for AVIM therapy. AVIM therapy is currently being evaluated under an FDA investigational device exemption ("IDE") in the BACKBEAT global pivotal study which is being conducted by Orchestra BioMed in collaboration with Medtronic. The BACKBEAT pivotal study is enrolling pacemaker-indicated patients with uncontrolled hypertension despite the use of anti-hypertensive medication, a key subpopulation under the BDD for which Orchestra BioMed believes AVIM therapy may offer optimal clinical benefit.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
New Simplera Sync sensor for the MiniMed 780G System now FDA approved

New Simplera Sync sensor for the MiniMed 780G System now FDA approved

Latest approval expands Medtronic CGM portfolio in the U.S.

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync™ sensor for use with the MiniMed™ 780G system. With this approval, the MiniMed™ 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection™ technology with both the Guardian™ 4 sensor and Simplera Sync™ sensor.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

FN Media Group News Commentary - Artificial intelligence (AI) is being utilized for disease detection in the global markets. In today's AI-driven world, the use of deep learning algorithms and AI tools in diagnostics can improve the accuracy, speed and efficiency for diagnosing patients with minimal errors. The introduction of AI tools in diagnostics has revolutionized the healthcare industry with supporting the doctors in advanced disease diagnosis and providing personalized treatments to patients with better judgements and quick results. According to Precedence Research, the global artificial intelligence in diagnostics market size was exhibited at USD 1.61 billion in 2024 and is projected to hit around USD 8.54 billion by 2033, growing at a CAGR of 20.37% during the forecast period 2024 to 2033. The report said: "The advances in digital biomarkers technology which uses real-time monitoring systems for early disease diagnosis and prediction has also enhanced the AI in diagnostics market growth. The application of AI tools in diagnostics has led to analyzing medical images for assessing disease progression, predicting patient outcomes, processing and storing of patient data which includes electronic health records (EHRs), identifying patterns and anomalies in patient data and symptom checkers for providing potential diagnosis."   Active healthcaretech companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Illumina Inc. (NASDAQ: ILMN), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Spectral AI, Inc. (NASDAQ: MDAI).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology .

The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
illustration of brain and cell phone.

BlinkLab Completes First Patient Test for US Autism Diagnostic Study

Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.

BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.

The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.

Keep reading...Show less
Artificial Intelligence Influence on Healthcare Industry Reaching All Time Highs for Diagnostics and Treatments

Artificial Intelligence Influence on Healthcare Industry Reaching All Time Highs for Diagnostics and Treatments

FN Media Group News Commentary - A report from Fortune Business Insights said that the global artificial intelligence in healthcare market size is projected to grow from USD 27.69 billion in 2024 to USD 490.96 billion by 2032, exhibiting a CAGR of 43.2% during the forecast period. The report added: "AI in healthcare market in the U.S. is experiencing rapid expansion, driven by the increasing adoption of AI-powered solutions for diagnostics, personalized treatment, and administrative automation. North America dominated the AI in the healthcare market with a market share of 44.93% in 2023. Artificial Intelligence in healthcare is used to analyze the medical data that helps doctors and medical providers deliver accurate diagnoses and treatments to their patients. AI in healthcare assists doctors, nurses, and other healthcare workers to enhance their productivity. This advancement helps patients in treatment and improves their quality of life. Also, according to an article published by GE Healthcare, it is found that healthcare professionals are already using AI to improve data analysis, which has enabled them to diagnose their patients in a better way with proper predictions for the treatment and decrease the time spent by the medical staff on administrative functioning." Active companies active in the healthcare markets include: Avant Technologies Inc. (OTCQB: AVAI), Tempus AI, Inc. (NASDAQ: TEM), Teladoc Health (NYSE: TDOC), Aclarion, Inc. (NASDAQ: ACON), Medtronic plc (NYSE:MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×