GlobeNewswire

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

About GlobeNewswire

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

https://globenewswire.com

GlobeNewswire 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

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

Latest releases from GlobeNewswire

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer27.1.2020 07:00:00 CETPress release

·Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Basel, 27 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The FDA is reviewing the application under the Real-Time Oncology Review pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In July 2018, the FDA granted Breakthrough Therapy Designation for Tecentriq in combination with Avastin in HCC based on data from an ongoing Phase Ib trial. “Liver cancer is the most rapidly increasing cause of cancer-related death in the United States. In the IMbrave150 study, Tece

Media Release | MCH Group | Extraordinary General Meeting - Shareholder Questions27.1.2020 07:00:00 CETPress release

Extraordinary General Meeting of MCH Group Ltd. on 29 January 2020: Board of Directors answers shareholder’s questions With the view to the Extraordinary General Meeting on 29 January 2020, MCH Group Ltd. has published the written answers to the list of questions submitted by a shareholder group. As one of various options for financing the investments required as part of the strategic realignment, the Board of Directors is examining the participation of new investors at group level, which can be combined with a capital increase and structural changes. On 26 November 2019, AMG Fondsverwaltung AG, representing the AMG Group (comprising Ursula Lee, Erhard Lee and LLB Swiss Investment AG and acting on behalf of AMG Substanzwerte Schweiz), requested the convocation of an Extraordinary General Meeting and submitted motions for the initiation of a special review of the strategy, for the disclosure of business records and for changes to the Statutes. In conjunction with the motion for the init

Beslut vid årsstämman i Eolus Vind AB den 25 januari 202025.1.2020 17:45:00 CETPressemelding

Hässleholm den 25 januari 2020. I enlighet med styrelsens förslag fastställde årsstämman utdelningen för räkenskapsåret 2018/2019 till 1,50 kronor per aktie med tisdagen den 28 januari 2020 som avstämningsdag. Bolagets styrelseledamöter och VD beviljades ansvarsfrihet. Sigrun Hjelmqvist, Hans Johansson, Jan Johansson, Hans Linnarson, Bodil Rosvall Jönsson samt Hans-Göran Stennert omvaldes till styrelseledamöter och Hans-Göran Stennert omvaldes som styrelsens ordförande. Registrerade revisionsbolaget PricewaterhouseCoopers AB omvaldes till revisor med auktoriserade revisorn Eva Carlsvi som huvudansvarig revisor. Arvode till styrelsen beslutades utgå med totalt 1 250 000 kronor, varav 375 000 kronor till ordföranden och 175 000 kronor vardera till övriga styrelseledamöter som inte är anställda i bolaget. Vidare beslutade stämman att arvode till revisorn ska utgå enligt avtal. I enlighet med förslag från valberedningen fastställde stämman instruktioner för utseende av valberedningen och v

Resolutions at the Annual General Meeting in Eolus Vind AB on January 25th, 202025.1.2020 17:45:00 CETPress release

Hässleholm, Sweden, January 25th, 2020. In accordance with the Board of Directors’ proposal, the Annual General Meeting (“AGM”) resolved to declare a dividend of SEK 1.50 per share for the financial year 2018/2019, and the record date for the payment of dividends was set to Tuesday, January 28th, 2020. The Board members and the CEO were discharged from liability. Sigrun Hjelmqvist, Hans Johansson, Jan Johansson, Hans Linnarson, Bodil Rosvall Jönsson and Hans-Göran Stennert were re-elected as members of the Board of Directors and Hans-Göran Stennert was re-elected as chairman of the Board. Accounting firm PricewaterhouseCoopers AB was re-elected as the company’s auditor, with authorized public accountant Eva Carlsvi as auditor in charge. It was decided that fees to the Board of Directors shall amount to SEK 1,250,000 in total, whereby the fee to the chairman shall amount to SEK 375,000 and the fees for each of the other Board members that are not employed by the company shall amount to

Gold Lion Closes Acquisition of Cuteye Group of Properties24.1.2020 22:05:00 CETPress release

VANCOUVER, British Columbia, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Gold Lion Resources Inc. (“Gold Lion” or the “Company”) (CSE: GL) (FWB: 2BC) is pleased to announce that it has closed its acquisition of the Cuteye Group of Properties from a private British Columbia numbered company (“Numberco”) (see the Company’s January 13, 2020 news release previously announcing the transaction). Under the transaction, Gold Lion issued an aggregate of 6,000,000 Gold Lion common shares to the shareholders of Numberco. No finder’s fees were paid in connection with the transaction. Gold Lion also announces the appointment of Mr. Dan Dente as a Director of the Company. Mr. Dente brings over 20 years’ experience within the financial services industry. About Gold Lion Resources Inc. Gold Lion Resources Inc. is a mineral exploration company, actively involved in the exploration of the Cuteye Group of Properties, as well as the Fairview Copper-Silver-Zinc Property. The Cuteye Group of Properties includes the M

Notice of fourth quarter 2019 results and conference call24.1.2020 18:05:00 CETPress release

Notice of fourth quarter 2019 results and conference call Luxembourg, January 24th, 2020 – Millicom will announce its fourth quarter results for the period ending December 31st, 2019, on February 25th, 2020 at approximately 12:00 (Stockholm) / 11:00 (London) / 6:00 (Miami) via a press release. The company will host a conference call for the global financial community on February 25th, 2020 at 14:00 (Stockholm) / 13:00 (London) / 08:00 (Miami). The conference call will be webcast at www.millicom.com Dial-in information: Please dial in 5-10 minutes before the scheduled start time to register your attendance. Dial-in numbers for the call are as follows: Sweden: +46 (0) 8506 92180 Luxembourg: +352 2786 0515 UK: +44 (0) 2071 928000 US: +1 631 5107 495 The access code is: 2348098 Replay information: A replay of the call will be available for 7 days from February 25th, 2020 at: UK: +44 (0) 3333 009785 US: +1 (917) 677-7532 Replay passcode is: 2348098 For further information, please contact Pr