GlobeNewswire by notified

IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints

Share

IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients

DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions. The study met primary safety and effectiveness endpoints and data were presented today at the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) annual meeting in Barcelona, Spain.

“Maintaining patency and limiting the frequency of reinterventions needed to keep AV access sites functioning properly remain significant treatment challenges for physicians treating AV fistulae lesions,” said Andrew Holden, M.D., director of interventional radiology at Auckland Hospital and associate professor of radiology at Auckland University. “These results demonstrate the promise of IN.PACT AV DCB to not only address these critical issues, but to potentially improve the quality of life of patients undergoing dialysis.”

AV fistulae, otherwise known as AV access sites, are created and used to deliver hemodialysis to patients with end-stage renal disease (ESRD). Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three AV fistula maintenance procedures per year.The need for frequent reinterventions can result in significant disruptions to critical hemodialysis care and increased costs to the healthcare system. Drug-coated balloons have the potential to extend the time between reinterventions by maintaining AV access site patency, therefore maximizing a patient’s uninterrupted access to lifesaving dialysis care.

The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan, and New Zealand. The primary effectiveness endpoint was defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through six months post-procedure and the primary safety endpoint was defined as the serious adverse event rate involving the AV Access circuit through 30 days post-procedure. Additional endpoints include but are not limited to: access circuit primary patency, cumulative target lesion revascularizations, and number of interventions required to maintain target lesion patency.

The study enrolled a challenging patient population who had been undergoing dialysis for an average of 4.3 years. Overall, the IN.PACT AV DCB group demonstrated clinical benefit compared to the PTA control group. Key data highlights include:

  •  Per Kaplan-Meier estimates, the primary patency rate of the target lesion at 180 days was 86.1% in the IN.PACT AV DCB group compared to 68.9% in the PTA control group (p<0.001).
  •  Per Kaplan-Meier estimates, the primary patency rate of the target lesion at 210 days was 81.4% in the IN.PACT AV DCB group compared to 59.0% in the PTA control group (p<0.001).
  •  Patients in the IN.PACT AV DCB group required 56.0% fewer reinterventions to maintain target lesion patency through 210 days compared to those in the PTA control group.
  •  A low rate of access circuit-related serious adverse events, with 4.2% in the IN.PACT AV DCB study group compared to 4.4% in the PTA control group through 30 days.

Additionally, the Kaplan-Meier estimated freedom from all-cause death through 360 days was 90.6% in the IN.PACT AV DCB study group and 90.4% in the PTA control group. This data adds to the initial safety data presented at U.S. Food and Drug Administration's Advisory Committee meeting of the Circulatory System Devices Panel in June, showing no difference in mortality rates in this patient population.

“The data presented today at CIRSE demonstrate the potential of IN.PACT AV DCB to address restenosis in high-risk patients who currently have few long-term treatment options available to them,” said Mark Pacyna, vice president and general manager of the Peripheral Vascular business, which is part of the Aortic, Peripheral, and Venous division at Medtronic. “As part of our commitment to improving outcomes, we look forward to generating further clinical evidence in support of this therapy.”

In the U.S., IN.PACT AV DCB is an investigational device and not yet approved for commercial use. In January 2016, the CE (Conformité Européene) indication for the IN.PACT™ Admiral™ DCB was expanded for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

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.

-end-

1 THE USRDS Special Study Center. Transition of care in CKD. Prelude to Dialysis: Trends and Timely Transitions. Kalantar-Zadeh K. Et Al. 2016

Julia Fuller
Public Relations
+1-858-692-2001

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

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye