LivaNova PLC Announces Approval of Perceval
LONDON, 2016-01-11 15:00 CET (GLOBE NEWSWIRE) --
LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN) (the “Company”) announced that, on January 8, 2016, the Company received approval from the United States Food and Drug Administration (“FDA”) for the Perceval Sutureless Heart Valve (“Perceval”). The approval is effective immediately, and the Company will begin commercial distribution of the device in the U.S. over the coming quarter.
Perceval is a surgical aortic valve with a unique self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place. The valve’s functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. Clinical results in patients implanted with Perceval have shown a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement with aortic cross-clamp times typically reduced by at least 50%.
“We are excited to bring this important product to the U.S. market, which will provide real value to patients and physicians,” said André-Michel Ballester, Chief Executive Officer. “The rapid acceptance of Perceval in Europe, an increasing number of positive publications on the product, and the solid preparation of our U.S. sales team, all provide a strong base for the achievement of our short and long term plans,” concluded Mr. Ballester.
Perceval is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The sale and distribution of the Perceval heart valve is limited to prescription use by specially-trained practitioners, and the Company has developed a nationwide training and proctoring program to help ensure the safety and effectiveness of the device.
LivaNova PLC, headquartered in London, UK, is a global medical technology company formed by the merger of Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and Cyberonics Inc., a medical device company with core expertise in neuromodulation. LivaNova transforms medical innovation into meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company employs approximately 4,500 employees worldwide. With a presence in more than 100 countries, LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac Surgery, and Neuromodulation, with operating headquarters in Clamart (France), Mirandola (Italy) and Houston (U.S.A.), respectively.
LivaNova is listed on NASDAQ and listed on the Official List of the UK’s Financial Conduct Authority and traded on London Stock Exchange (LSE) under the ticker symbol “LIVN”.
For more information, please visit www.livanova.com, or contact:
Chief Financial Officer
Investor Relations and Media:
Senior Vice President, Finance
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
FDA Grants Diazyme 510(k) Clearance to Market Its New EZ Vitamin D Assay for Clinical Chemistry Analyzers22.1.2018 15:00 | Pressemelding
SAN DIEGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers. Diazyme's two reagent EZ Vitamin D assay provides the only fully automated two reagent Vitamin D test for use on validated clinical chemistry analyzers. "Diazyme's EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analyzers. This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. This assay enables clinical laboratories of almost any size to run Vitamin D test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellen
Fura Completes Acquisition of Colombian Emerald Mine, Coscuez22.1.2018 13:00 | Pressemelding
TORONTO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Fura Gems Inc. (TSXV:FURA) is pleased to announce that it has completed its acquisition of 76% of the issued and outstanding shares of Esmeracol S.A. ("Esmeracol"), which owns a 100% interest in mining licence no. 122 - 95M (the "Coscuez Licence"). Dev Shetty, President & CEO of Fura, commented: "Fura has achieved one more important milestone by adding the iconic Colombian emerald mine, Coscuez, to its portfolio. With this acquisition, Fura now has two important silos in its portfolio, Colombian emeralds and Mozambican rubies. Fura will now work towards modernisation of the Coscuez emerald mine and deployment of the best health and safety standards for its employees while keeping the environmental impact minimal. Fura will also closely work with the local community and relevant authorities to promote the social-economic development in the region. We would like to thank our local partner and also the entire team on the ground in the Colombia fo
Agency for the Cooperation of Energy Regulators (ACER) continues to use Nasdaq's SMARTS for Pan-European Market Monitoring of EU Wholesale Energy Markets22.1.2018 12:30 | Pressemelding
NEW YORK, Jan. 22, 2018 (GLOBE NEWSWIRE) -- The Agency for the Cooperation of Energy Regulators (ACER) has officially extended its contract with Nasdaq (Nasdaq:NDAQ) to continue to leverage Nasdaq's SMARTS Market Surveillance technology to detect insider trading and market manipulation across the European Union's wholesale energy markets by digesting and analyzing massive volumes of data from hundreds of power producers, exchanges, operators, and brokers across 28 member states. The new agreement contract extension will continue to allow national regulatory authorities to share data, technology, and expertise, with the aim of creating a cooperative regulatory infrastructure. Under the contract, SMARTS technology will continue being leveraged to monitor the European wholesale gas and electricity markets, covering both spot trading and derivative markets across Europe in accordance with the obligations under the REMIT legislation. Further, the surveillance technology will support ACER's
Bell Canada Reaches Milestone in Network 3.0 Vision with Open Network Automation Platform (ONAP) and Strategic Partnership with Amdocs22.1.2018 12:00 | Pressemelding
Bell's leadership in bringing open source ONAP into production enables innovative new offerings to customers faster and at lower cost ST. LOUIS, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Amdocs (NASDAQ:DOX), a leading provider of software and services to communications and media companies, today announced that Bell, Canada's largest communications company, has successfully implemented the first network automation use case in production leveraging the Linux Foundation's Open Network Automation Platform (ONAP). As Bell's strategic partner, Amdocs brings unparalleled ONAP expertise and DevOps scrum team agility and delivery capabilities with the goal of driving innovation faster and reducing the cost of building and operating the data center of the future. With clear benefits such as a more elastic network and increased business agility to be gained from taking advantage of network functions virtualization (NFV), Bell is driving its network transformation by leveraging the ONAP-based network serv
Alvogen CEO Robert Wessman speaks exclusively to World Finance about new opportunities in generic pharmaceuticals22.1.2018 11:51 | Pressemelding
LONDON, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Industry disruptor Robert Wessman, the CEO of rapidly growing generic pharmaceuticals company Alvogen, shares his thoughts on the latest market trends in the new edition of World Finance magazine. Only different in name and price, generic pharmaceuticals in the US are a whopping 50 to 70 percent less expensive than their branded equivalents. Unsurprisingly, in an era of ever-rising medical costs, a growing number of governmental entities and corporations are now choosing generics over branded pharmaceuticals. For some time, just a handful of big-name organisations dominated this nascent market. But, following its peak in 2015, over-valuations have prompted vulnerability, opening the door for new, more nimble competitors to join and disrupt the market. Among this innovative group of 'next generation' pharmaceutical companies is Reykjavik-based Alvogen. Though it was only established in 2009, this global-facing organisation now boasts an annual t
SD-WAN Market Leader Aryaka Names Claudio Perugini Senior Vice President of Global Channels22.1.2018 06:00 | Pressemelding
SAN MATEO, Calif., Jan. 22, 2018 (GLOBE NEWSWIRE) -- Aryaka®, the leading global SD-WAN provider, announced today that networking industry veteran Claudio Perugini has joined the company's leadership team as Senior Vice President of Global Channels. In his new role, Perugini will lead and further scale Aryaka's global partner program as the company continues to grow rapidly and expand its market footprint in 2018. "Aryaka's channel partners have played an essential role in establishing the company as the market leader in the global SD-WAN space," said Perugini. "Our technology is a game-changer for the channel community as we offer global enterprises a next-generation alternative to legacy network technologies. As the Senior Vice President of Global Channels, my key focus areas will be recruitment, further scaling the channel organization, enhancing the structure of the Aryaka Global Partner Program, and improving partner enablement." Perugini has more than 30 years of channel and sale
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom