GlobeNewswire

Medtronic Evolut TAVI System Receives Expanded Indication in Europe to Treat Severe Aortic Stenosis Patients at Low Risk for Surgical Mortality

Share

The Evolut TAVI Platform Receives New Indication for Patients with Bicuspid Aortic Valves at Extreme, High or Intermediate Risk of Surgical Mortality

DUBLIN, June 22, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced CE (Conformité Européenne) mark and European launch of the Evolut™ Transcatheter Aortic Valve Implantation (TAVI) system for patients with severe native aortic stenosis who are at a low risk of surgical mortality. The low-risk patient population is the final surgical risk category to be approved for this minimally invasive alternative to open-heart surgical valve replacement (SAVR) and includes patients who may be younger1 and more active than higher-risk patients. The Evolut TAVI platform also received a new indication approval that allows for the treatment of patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

The expanded low-risk indication approval is based on clinical data from the global, prospective, randomized, multi-center Evolut Low Risk Trial, which evaluated three valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves) against SAVR in more than 1,400 patients. The data showed TAVI to have an excellent safety profile and be an effective treatment option in low-risk patients with shorter hospitals stays and improved 30-day quality-of-life scores compared to SAVR. In addition to a lower rate of the composite of all-cause death or disabling stroke with TAVI at 30 days, the Evolut system demonstrated superior hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients and larger EOAs (effective orifice area) compared to surgery at one year – factors that may be important for more active patients. The rate of new pacemaker implantation and residual aortic regurgitation was higher in the TAVI group.

“The low-risk indication marks an important milestone for patients across Europe as TAVI expands into a potentially younger and more active patient population,” said Thomas Modine, M.D., Ph.D, MBA, cardiac surgeon at Hôpital Cardiologique Lille, in Lille, France, and investigator in the Evolut Low Risk Trial. “While surgical valve replacement will still be an option for many patients, we anticipate TAVI to be accepted as an important valve replacement therapy in patients for whom it is an appropriate treatment option. Heart teams will have more freedom to choose the best aortic valve replacement procedure based on each patient’s individual characteristics.”

The Evolut TAVI System, with its excellent hemodynamics, allows for improved heart function that helps many patients resume their pre-aortic stenosis activity. The valve is engineered with a self-expanding nitinol frame that conforms the replacement valve to the native annulus with consistent radial force and includes an external tissue wrap that increases surface area contact with native anatomy for enhanced valve sealing. The CoreValve device leads the industry in longer-term clinical data, reporting durability data out to 8 years with the Italian Registry on the original CoreValve TAVI.

Severe aortic stenosis, which occurs when the aortic valve becomes diseased (stenotic), affects approximately more than 500,000 patients in western Europe per year. The valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and, therefore, impacting an individual’s daily activities. If left untreated, symptomatic patients with severe aortic stenosis can die from heart failure in as little as two years.

With this approval, the Evolut TAVI platform is now indicated in Europe for severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low), and includes new labeling that allows for the treatment of patients with bicuspid aortic valves for patients at extreme, high and intermediate risk of surgical mortality. The Evolut TAVR platform is indicated in the U.S. for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low). Bicuspid valve patients at intermediate risk or higher may be candidates for TAVR in the U.S.

“It is important that we expand access to a less invasive treatment option to this low-risk patient population. It’s also encouraging that we now have new labeling to address a large portion of bicuspid valve patients, too,” said Didier Tchétché, M.D., interventional cardiologist and director of the Structural Heart Disease Department at Clinique Pasteur in Toulouse, France, and investigator in the Evolut Low Risk Trial. “Based on excellent data from the STS/ACC TVT Registry, bicuspid patients (excluding low risk), will for the first time, be indicated for TAVI, which is another big win for patients and the future of the therapy.”

Bicuspid aortic valves are a congenital heart defect affecting 1-2 percent of the general population and is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid). Further, bicuspid aortic valve stenosis represents almost 40 percent of the intermediate and high risk severe symptomatic aortic stenosis patient population.2

“With these approvals, more patients will now be candidates for the Evolut TAVI system while surgical aortic valve replacement will evolve to serve a more complex patient population,” said Pieter Kappetein, M.D., Ph.D., vice president and chief medical officer for the Structural Heart and Cardiac Surgery businesses, which are part of the Cardiac and Vascular Group at Medtronic. “Medtronic is well positioned to provide a variety of therapy options to meet the varying needs of patients with heart valve disease.”

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 Earlier CoreValve Evolut TAVR trials enrolled patients at an average age of 80 to 83 while the Evolut Low Risk trial enrolled patients at an average age of 74).

2 Medtronic data on file.



Joey Lomicky
Public Relations
+1-763-526-2494

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

Election Committee for Eolus Vind AB appointed16.7.2020 13:00:00 CESTPress release

Hässleholm, Sweden, July 16, 2020 The Election committee consists of the following members: Hans-Göran Stennert, Chairman of the Board, Eolus Vind AB. Ingvar Svantesson, appointed by Domneåns Kraftaktiebolag. Hans Gydell, appointed by Hans-Göran Stennert. Hans Johansson, appointed by Åke Johansson. According to a decision of the Annual General Meeting of January 25, 2020, the Election Committee shall consist of one member appointed by each of the three largest shareholders and the Chairman of the Board. The appointment of the Election Committee has been carried out in such a manner that, Hans-Göran Stennert, Chairman of the Board of Eolus, on the basis of the Euroclear list of registered shareholders as of 31 May 2020, has contacted the largest known shareholders in the company, who have been invited to each propose a representative to the Election Committee. After such contacts, the Election Committee has been appointed. In total, approximately 34.3 percent of the votes are represente

Valberedning för Eolus Vind AB utsedd16.7.2020 13:00:00 CESTPressemelding

Hässleholm den 16 juli 2020 Valberedningen består av följande ledamöter: Hans-Göran Stennert, styrelseordförande i Eolus Vind AB. Ingvar Svantesson, utsedd av Domneåns Kraftaktiebolag. Hans Gydell, utsedd av Hans-Göran Stennert. Hans Johansson, utsedd av Åke Johansson. Enligt beslut på årsstämman den 25 januari 2020 skall valberedningen bestå av en ledamot utsedd av envar av de tre röstmässigt största ägarna jämte styrelseordföranden. Tillsättningen av valberedningen har skett genom att Eolus styrelseordförande Hans-Göran Stennert på grundval av bolagets, av Euroclear tillhandahållna, förteckning över registrerade aktieägare per den 31 maj 2020 kontaktat de för bolaget största kända ägarna, vilka uppmanats att var och en föreslå en representant till valberedningen. Efter sådana kontakter har valberedningen utsetts. Totalt representeras cirka 34,3 procent av rösterna i valberedningen. Valberedningens uppgift är att inför årsstämman 2021 framlägga förslag avseende antal styrelseledamöter

UPM permanently closes its Chapelle newsprint mill16.7.2020 10:00:00 CESTPress release

(UPM, Helsinki, 16.07.2020 at 11:00 EET) – UPM will permanently cease production at its Chapelle newsprint mill in Grand-Couronne, France today. The consultation process with employee representatives was completed on June 15th, 2020 according to French legislation and approved by French authorities on July 15th, 2020. The closure impacts 228 people. UPM offers support to employees in order to alleviate the effects caused by staff reductions in relation to the closing of the mill. With the closure of the mill UPM will reduce a total of 240.000 tonnes of its newsprint paper capacity. “After UPM announced the intention to sell the Chapelle mill in September we started an active sales process and have been in discussions with interested parties since. However, we have not received binding offers by potential buyers. Consequently, we decided to close the mill, while at the same time working with employee representatives to mitigate the social impact on our employees. We remain committed to

Invitation to UPM’s webcast and press conference on half-year financial report 202016.7.2020 09:00:00 CESTPress release

(UPM, Helsinki, 16 July 2020 at 10:00 EET) – UPM will publish its half-year financial report 2020 on 23 July 2020 at 09:30-10:00 EET. After publishing the report will be available on company's website at www.upm.com. A webcast and a conference call for analysts and investors in English language begins at 13:15 EET. UPM’s financial results will be presented by the President and CEO Jussi Pesonen and CFO Tapio Korpeinen. All participants can view the webcast online at www.upm.com or through this link, but participants who wish to ask questions must attend the conference call by dialling a number in the list below: Conference call title: UPM Interim Report for January – June 2020 International telephone numbers: Australia Toll: +61 284058549 Austria Toll: +43 19287907 Belgium Toll: +32 24035814 Denmark Toll: +45 35445577 Finland Toll: +358 981710310 France Toll: +33 170750711 Germany Toll: +49 6913803430 Hong Kong Toll: +852 30600225 India Toll: +91 2271279610 Ireland Toll: +353 14311252

CellaVision AB: God lönsamhet trots negativ covid-19-effekt16.7.2020 08:20:00 CESTPressemelding

Informationen lämnades för offentliggörande 2020-07-16 kl 08.20 1 april–30 juni 2020 Nettoomsättningen ökade med 5% till 118,0 MSEK (112,4).Organiskt minskade omsättningen med 15% (+18).EBITDA uppgick till 36,2 MSEK (41,3).EBITDA-marginalen uppgick till 31% (37).Resultatet före skatt uppgick till 34,4 MSEK (37,9).Resultat per aktie före och efter utspädning uppgick till 1,14 SEK (1,27).Kassaflödet från den löpande verksamheten uppgick till 34,1 MSEK (17,3). 1 januari–30 juni 2020 Nettoomsättningen ökade med 17% till 252,5 MSEK (216,3). Organiskt minskade omsättningen med 8% (+24). EBITDA uppgick till 77,4 MSEK (79,6). EBITDA-marginalen uppgick till 31% (37). Resultatet före skatt uppgick till 59,8 MSEK (72,8). Resultat per aktie före och efter utspädning uppgick till 1,99 SEK (2,42). Kassaflödet från den löpande verksamheten uppgick till 49,5 MSEK (68,4). Väsentliga händelser relaterade till covid-19 Bolaget räknar med att covid-19-pandemin kommer att ha en betydande negativ påverkan p

CellaVision AB: Good profitability despite negative COVID-19-effect16.7.2020 08:20:00 CESTPress release

The information was submitted for publication at 08.20 CET on July 16, 2020 1 April -30 June 2020 Net sales increased by 5% to SEK 118.0 million (112.4).Sales decreased organically by 15% (+18).EBITDA amounted to SEK 36.2 million (41.3).EBITDA margin amounted to 31% (37).Profit before tax amounted to SEK 34.4 million (37.9).Earnings per share before and after dilution were SEK 1.14 (1.27).Cash flow from operating activities amounted to SEK 34.1 million (17.3). 1 January-30 June 2020 Net sales increased by 17% to SEK 252.5 million (216.3).Sales decreased organically by 8% (+24).EBITDA amounted to SEK 77.4 million (79,6). EBITDA margin amounted to 31% (37).Profit before tax amounted to SEK 59.8 million (72.8).Earnings per share before and after dilution were SEK 1.99 (2.42).Cash flow from operating activities amounted to SEK 49.5 million (68.4). Significant events related to COVID-19 The company expects the COVID-19 pandemic to have a significant negative impact on CellaVision's sales an