Business Wire

VNS Therapy Receives CE Mark for Expanded MRI Labeling

Del

LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced its latest VNS Therapy® Systems (“VNS Therapy”) received CE Mark for expanded MRI labeling. VNS Therapy is now the only implantable device indicated for epilepsy therapy that allows patients to have high-quality 1.5T and 3T MRI scans without the need for special equipment.

“The CE Mark comes one month after we received U.S. FDA approval for similar expanded MRI labeling,” said Damien McDonald, LivaNova’s Chief Executive Officer. “Earning CE Mark and FDA approval to expand our MRI labeling removes a barrier to care for patients with drug-resistant epilepsy.”

The labeling change applies to the latest VNS Therapy technology, which includes AspireHC® and AspireSR® devices. Now, patients who have or desire to have VNS Therapy can more easily receive routine MRI scans.

“In addition to offering patients more seizure-free moments, we can now better support comprehensive epilepsy treatment throughout a patient’s lifetime,” adds Jason Richey, LivaNova’s President of North America & General Manager of the Neuromodulation franchise.

To date, more than 100,000 patients worldwide use VNS Therapy—a minimally invasive treatment designed to prevent seizures before they start and stop them if they do. More than one in three people with epilepsy has drug-resistant seizures, meaning seizures persist in spite of treatment with antiepileptic medications.1 To learn more, visit www.VNSTherapy.com or www.SeizureControl.com.

INTENDED USE/INDICATION – EPILEPSY – EU

The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.

AspireSR™ (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience cardiac rhythm increases that are associated with seizures.

Common side effects include hoarseness or changes in voice tone, prickling feeling in the skin, shortness of breath, sore throat and coughing. Visit www.VNSTherapy.com/important-safety-information to view safety and full prescribing information.

1. Kwan P., Brodie M.J. New England Journal of Medicine. 2000;342:314-19.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London and with a presence in more than 100 countries worldwide, the company employs more than 4,500 employees. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation and Cardiac Rhythm Management, with operating headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart (France), respectively.

For more information, please visit www.livanova.com .

Contact information

LivaNova PLC
Deanna Wilke, +1-281-727-2764
Corporate External Communications Manager
corporate.communications@livanova.com
or
Havas PR
Melissa Reiger, +1-412-251-2172
melissa.rieger@havas.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Ant Financial to Share Full Suite of AI Capabilities with Asset Management Companies20.6.2018 01:10Pressemelding

Ant Financial Services Group (“Ant Financial” or “the Company”) today announced that the Company will share a full suite of AI capabilities with asset management companies in China to support their digital transformation. Following its successful launch last year, Caifuhao, an AI-powered corporate account on the Ant Fortune platform, has brought tangible benefits to 27 fund management companies. “By combining Ant Financial’s AI technologies with the capabilities of asset management companies in investor education and fund management, together we are making customized wealth management services more accessible for ordinary users,” said Eric Jing, Executive Chairman and CEO of Ant Financial. With the support of AI-powered services offered by their Caifuhao account, including operational optimization, content generation, compliance and risk management, 27 fund management companies have been able to increase their operational efficiency by 70% while reducing their overall costs by 50%. Add

Avalara Announces Closing of Initial Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares19.6.2018 21:20Pressemelding

Avalara, Inc. (NYSE: AVLR) today announced the closing of its initial public offering of 8,625,000 shares of common stock, including the full exercise by the underwriters of their option to purchase 1,125,000 additional shares of common stock, at a price to the public of $24.00 per share. The shares began trading on the New York Stock Exchange on June 15, 2018 under the symbol “AVLR.” Goldman Sachs & Co. LLC, J.P. Morgan, and BofA Merrill Lynch acted as book-running managers for the offering. JMP Securities, KeyBanc Capital Markets, and Stifel acted as co-managers. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at 866-471-2526, or by email at prospectus-ny@ny.email.gs.com, or from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at

Unilever Calls on Content Creators and Distributors to Eradicate Stereotypes19.6.2018 17:42Pressemelding

Unilever is calling on content creators and distributors to act now to eliminate outdated stereotypes. The move marks the latest step in the company’s industry-leading Unstereotype initiative, which launched two years ago with the aim of eliminating harmful and diminishing portrayals of people across advertising. As part of its Unstereotype commitment Unilever is expanding that initiative across all forms of content and branded entertainment, and today announces a three-year multi-million-dollar deal with Rexona, the world’s biggest deodorant brand, and Simon Fuller’s XIX Entertainment. Rexona (also known as Sure, Degree and Shield depending on the country) will partner with NOW UNITED, the first ever global pop group comprised of 14 artists from 14 countries including Brazil, China, Germany, India, Philippines, Senegal, US and UK. Together, will co-create content across multiple channels that unites different cultures through the joy of dance, celebrating movement and inspiring people

Universal Laser Systems Expands Its Materials Database with Henkel, Hexcel and Saint-Gobain Materials19.6.2018 12:05Pressemelding

Universal Laser Systems (ULS) announces the addition of Henkel, Hexcel® and Saint-Gobain materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The Henkel, Hexcel and Saint-Gobain materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: Henkel Bergquist™ Gap Pad® VO Thermal Material Henkel Bergquist™ Hi-Flow® 105 Thermal Material Henkel LOCTITE® EA 7000 AERO Film Henkel Hysol® EA 9696 AERO Film Henkel Bergquist™ Sil-Pad A2000 Thermal Material Hexcel® HexForce® 353 Aramid Fabric Hexcel® HexForce® 282 Carbon Fabric Saint-Gobain CHEMFILM® DF100 Cast PTFE Film Saint-Gobain CHEMFILM® ETFE-E2 Extruded Fluoropolymer Film Laser processing notes, describing the results of the laser-material interaction fo

Valence Advises Itaúsa on Sale of Brazilian Chemical Co Elekeiroz to H.I.G. Capital19.6.2018 11:57Pressemelding

The Valence Group acted as advisor to Itaúsa on its sale of Brazilian chemical company Elekeiroz for R$160 million (EV), reduced by the net debt and proportionate to its shareholding (96.5% of total capital stock). The Company is a leading local producer of oxo-alcohols, plasticizers and anhydrides. About Itaúsa Itaúsa is a Brazilian holding company which controls several companies active in areas such as the financial sector; industries include wood panels, bathroom fittings and fixtures; infra-structure; and retail. It is one of the largest private conglomerates in Brazil and one of the largest in the world. About Elekeiroz Founded in 1894 and headquartered in Várzea Paulista – São Paulo, Elekeiroz operates in the chemicals manufacturing market. Through two production sites in Várzea Paulista and Camaçari – Bahia, the Company’s portfolio includes Oxo-Alcohols, Plasticizers, Phthalic & Maleic Anhydrides, Sulfuric Acid and other by-products. Elekeiroz has a diversified client base, com

Dole Adds Industry Veteran Michael Solomon as President of Dole Fresh Vegetables19.6.2018 10:00Pressemelding

Dole Food Company, Inc. announced the appointment of Michael H. Solomon as the new President of Dole Fresh Vegetables effective June 18, 2018. As Dole Fresh Vegetables President, Solomon will have responsibility for all of the division's operations across North America. He will report directly to Dole Food Company President and Chief Executive Officer Johan Linden. With 30 years experience, including within the food and beverage industry, Solomon has a proven success record of taking high-performance brands to the next level, increasing performance and margins in sales, plant operations, and profit growth. Among other positions, Solomon has held roles of President of POM Wonderful and President and CEO of Ready Pac Foods, Inc., prior to joining Dole. “Michael has built an impressive track record of strategic, operational and commercial accomplishments,” said Johan Linden, President and Chief Executive Officer of Dole Food Company. “He has considerable experience and knowledge of the fr