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Clinical Trials

OrbusNeich’s Genous Bio-engineered R stent Shows Favorable Safety Profile and Clinical Outcomes in Combination with Paclitaxel-Coated Balloon for De Novo Coronary Artery Disease

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PRESS RELEASE

OrbusNeich today announced that six-month follow-up clinical trial data demonstrate the excellent safety profile and efficacy of the company’s Genous Bio-engineered R stent in combination with a paclitaxel-coated balloon for the treatment of de novo coronary artery disease. The data were presented by Jochen Woehrle, M.D., University of Ulm, Germany, principal investigator of the study, in the first report clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington.

Abiomed Reports Updated USpella Results at TCT 2010

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PRESS RELEASE

Abiomed, Inc. (NSDQ:ABMD), a leading provider of breakthrough heart support technologies, today announced updated clinical data from USpella, a U.S. multicenter, observational registry of Impella 2.5 patients.

The new updates, presented today at TCT 2010 reported that 24 U.S. and Canadian centers have contributed data for a total of 352 patients. The USpella registry results were last announced on May 15, 2010 at EuroPCR 2010.

Abbott’s XIENCE V Shows Continued Strong Performance in Key Safety and Efficacy Measures at Two Years in Investigator-Initiated COMPARE Trial

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PRESS RELEASE

Late-breaking data were presented today from the investigator-initiated COMPARE trial of 1,800 real-world patients involving Abbott’s market-leading XIENCE V Everolimus Eluting Coronary Stent System and the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System (TAXUS). The results from COMPARE at two years were presented by Peter Smits, M.D., of Maasstad Ziekenhuis, Rotterdam, the Netherlands, during the Cardiovascular Research Foundation’s 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.

Abbott’s XIENCE V Shows Outstanding Two-Year Clinical Results Versus TAXUS in Key Safety and Efficacy Measures in SPIRIT IV Trial

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PRESS RELEASE

Late-breaking data from the SPIRIT IV trial, one of the largest randomized clinical trials between two drug eluting stents, continued to demonstrate outstanding clinical results of Abbott’s market-leading XIENCE V Everolimus Eluting Coronary Stent System versus the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System (TAXUS) in key areas of safety and efficacy through two years. The impressive two-year results were presented today by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center and NewYork-Presbyterian Hospital, during the Cardiovascular Research Foundation’s 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C.

ImThera Medical Reports Interim Data from OSA Neurostimulation European Clinical Study

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PRESS RELEASE

ImThera Medical, Inc. today announced interim results from its OSA European clinical study. For the study, ten patients have been surgically implanted with ImThera’s aura6000™ hypoglossal nerve neurostimulation device for treating Obstructive Sleep Apnea (OSA). The target population for ImThera’s neurostimulation device is moderate and severe OSA patients who are non-compliant with or cannot tolerate Continuous Positive Airway Pressure (CPAP).

Elixir Medical Corporation Initiates Enrollment in the EXCELLA BD Randomized Clinical Trial of the Elixir Novolimus Eluting Coronary Stent System with Bioabsorbable Polymer

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PRESS RELEASE

Elixir Medical Corporation, a developer of product platforms that combine innovative medical devices with potent pharmaceuticals for site-specific therapies, announced the initiation of patient enrollment in the EXCELLA BD Randomized Clinical Trial designed to evaluate Elixir’s next generation Novolimus Eluting Coronary Stent System (CSS) with bioabsorbable coating, the Elixir DESyne BD Novolimus Eluting CSS. The first cases were enrolled by Professor Joachim Schofer from the Universitäres Herz-und Gefäβzentrum in Hamburg, Germany and Dr. Karl E. Hauptmann from the Krankenhaus der Barmherzigen Brüder in Trier, Germany.