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  

 
 

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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.

 

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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.

 

 

 

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