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Press Releases

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) praised several process improvements included in the recently announced medical device user fee agreement with FDA, stressing they would lead to greater efficiency, consistency and accountability in the agency’s device review process.

 

DUBLIN and ROME - Aug. 29, 2016 - Medtronic plc (NYSE:MDT) today announced results from the Cardiac Resynchronization Therapy Efficacy Enhancement (CRTee) study. The study showed that the Medtronic-exclusive device-based EffectivCRT(TM) during AF algorithm improves therapy delivery in heart failure patients with atrial fibrillation (AF). The results were presented at the 2016 European Society of Cardiology (ESC) Congress in Rome.

Amsterdam, Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA) today announced its sponsorship of the documentary COPD: Highly Illogical - Remembering Leonard Nimoy. The documentary seeks to educate viewers about COPD through Leonard Nimoy’s personal story of courage, while also providing the latest information about treatments for the chronic disease.

PR Newswire, CINCINNATI, Aug. 22, 2016: Ethicon*, a trusted leader in advancing wound closure, announces the launch of STRATAFIX Spiral PDS Plus and STRATAFIX Spiral Monocryl Plus Knotless Tissue Control Devices. 

DUBLIN - Aug. 26, 2016 - Medtronic plc (NYSE: MDT), on behalf of its indirect, wholly-owned subsidiary HeartWare International, Inc., today announced that, in connection with the completion of the acquisition of HeartWare by Medtronic, HeartWare has commenced an offer to repurchase (the "Convertible Notes Repurchase Offer"), at the option of each holder, any and all of its outstanding 3.50% Convertible Senior Notes due 2017 (the "2017 Notes") and 1.75% Convertible Senior Notes due 2021 (the "2021 Notes," and together with the 2017 Notes, the "Notes"). 

DUBLIN - Aug. 23, 2016 - Medtronic plc (NYSE: MDT), the global leader in medical technology, has completed its acquisition of HeartWare International, Inc., a leading innovator of less-invasive, miniaturized, mechanical circulatory support technologies (MCS) for treating patients with advanced heart failure.

Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today the first two patients with abdominal aortic aneurysms (“AAA”) have been treated with the Ovation Alto™ Abdominal Stent Graft System. The patients were treated by Andrew Holden, MD, and Andrew Hill, MD, of Auckland City Hospital, Auckland, New Zealand.

Minneapolis, MN, Aug. 11, 2016 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing the PURE EP(TM) System, a novel cardiac electrophysiology (EP) information system, today announced the Journal of the American College of Cardiology: Clinical Electrophysiology has published an article entitled “Novel Electrophysiology Signal Recording System Enables Specific Visualization of the Purkinje Network and Other High-Frequency Signals” by Ammar M. Killu, MBBS, Niyada Naksuk, MD, Kalpathi L. Venkatachalam, MD, and Samuel J. Asirvatham, MD from Mayo Clinic.

IRVINE, Calif., July 27, 2016 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that Health Canada has approved the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients living with severe, symptomatic aortic stenosis and at high or greater risk for surgical aortic valve replacement.

REDWOOD CITY, Calif. – July 21, 2016 – Providence Health Care has become the first center in Canada to adopt the HeartFlow® FFRctAnalysis, and also first in the world to utilize the next generation version of the platform. The HeartFlow FFRct Analysis, which was recently approved by Health Canada, is a novel, non-invasive technology used by clinicians to assess their patients for coronary artery disease. 

WALTHAM, MA – July 5, 2016 – Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, announced that its CorPath® System will be highlighted in several presentations on new therapies and techniques for the treatment of high-risk patients with complex cardiovascular disease at SDCI 2016: San Diego Cardiovascular Interventions Course, July 8 and 9, at the Estancia La Jolla Hotel & Spa, La Jolla, CA. Corindus' CorPath System, the first FDA-cleared medical device to bring robotically-assisted precision to radial, coronary and peripheral procedures, will be featured in two live robotic-assisted complex percutaneous coronary interventions (PCIs) during the course.

DUBLIN - July 13, 2016 - Medtronic plc (NYSE: MDT) has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm length balloon, available in four, five, and six mm diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease (PAD). 

ST. LOUIS, July 13, 2016 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that the University of Chicago Medicine will implement the Company’s Niobe® ES remote magnetic navigation system as part of its vision to create a cutting-edge arrhythmia technology suite. 

LOS ANGELES, July 12, 2016 /PRNewswire-USNewswire/ --  Good Samaritan Hospital is the first hospital on the West Coast to offer patients with coronary artery disease (CAD) a first-of-its-kind dissolving heart stent.   Abbott's Absorb™ dissolving heart stent is a drug eluting coronary stent that dissolves, completely and naturally, in the body over time.  Absorb™ treats coronary artery disease like a metallic stent, propping the diseased vessel open to restore1 blood flow, but then disappears after the artery is healed, leaving no metal behind to restrict natural vessel motion.

TAMPA, Fla., July 13, 2016 /PRNewswire/ -- CareDx, Inc. (NASDAQ: CDNA), a molecular diagnostics company, today called for Medicare Administrative Contractor First Coast Service Options, Inc. to reverse its recent proposal to drastically reduce reimbursement for its FDA-cleared diagnostic test AlloMap, which measures gene expression levels to help clinicians determine a heart transplant recipient's risk for organ rejection. 

WBR technology increases patient safety and comfort, reduces nuclear radiation doses, and shortens scan times.

WINSTON-SALEM, N.C., June 23, 2016 /PRNewswire-USNewswire/ -- Researchers at Wake Forest Baptist Medical Center have developed a medical app for risk-evaluation and clinical support that can help emergency department personnel more efficiently determine which patients with acute chest pain can be discharged safely. 

DUBLIN - June 28, 2016 - Medtronic plc (NYSE:MDT) today announced availability of its Beacon Heart Failure Management Service in the United States. This new service from Medtronic Care Management Services (MCMS) combines data from Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices with post-acute monitoring from MCMS, enabling providers to focus on heart failure patients with the greatest risk and evaluate early intervention before a heart failure event occurs. 

Insignia Medical Systems, the pioneering UK based Picture Archiving and Communication System (PACS) provider, is pleased to announce the appointment of a new Software Engineer, Brett Jones, who joins their growing development team.

SAN RAMON, Calif., June 17, 2016 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced that it has launched the PHenomenal campaign, which gives people with PH and their loved ones the opportunity to submit photos and videos of themselves showing what makes them interesting and inspiring. To learn more about PH and the PHenomenal campaign, please visit http://youtube.com/c/SteadymedPHenomSelf

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