News

September 27, 2010 – A premarket approval (PMA) application has been submitted for the Formula balloon-expandable stent to help treat patients suffering from renal artery stenosis. Cook Medical’s submission to the U.S. Food and Drug Administration (FDA) included data from the REFORM trial.

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Technology

September 27, 2010 - Treating varicose veins with a new access kit reduces the number of steps and reduces procedure time. The .018-inch nitinol long-access wire for the VenaCure EVLT system, by AngioDynamics, reduces the number of components involved.

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Technology

September 27, 2010 – Designed for productivity and versatility, the new GE Healthcare Innova 3100-IQ (Optima Edition) is a reliable, cost-effective, high-performance interventional combo lab for treating a wide variety of patients. It addresses diverse interventional cardiology and interventional radiology needs with one system. The system was unveiled at TCT 2010.

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September 24, 2010 - Trial data have established the safety of a reversible PAR-1 thrombin receptor antagonist in patients with acute coronary syndrome. Results from the LANCELOT ACS trial were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting in Washington, D.C. The study looked at atopaxar, by Eisai Pharmaceuticals.

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September 24, 2010 – Drug-eluting stents are beneficial in treating symptomatic peripheral artery disease (PAD) in the femoropopliteal artery. Data from the ZILVER PTX trial demonstrate that paclitaxel-eluting stents had significantly better 12-month patency rates compared to traditional angioplasty with bare-metal stents for lesions in the femoropopliteal artery (above the knee).

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September 24, 2010 - Two-year data from the SPIRIT IV trial show that everolimus-eluting stents demonstrated enhanced safety and efficacy in treating de novo native coronary artery lesions when compared to paclitaxel-eluting stents.

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September 24, 2010 - The first in-human study of a robotically assisted percutaneous coronary intervention system demonstrated that the technique is safe and feasible. The results of the study, which used the CorPath 200 by Corindus Vascular Robotics, were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting.

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September 24, 2010 - The New England Journal of Medicine has published the results of from a trial looking at the treatment of severe aortic stenosis. The results from cohort B of the Partner trial, which studied the Edwards Sapien transcatheter heart valve, successfully met the primary endpoints of all-cause mortality and mortality plus repeat hospitalization.

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September 24, 2010 - The U.S. Food and Drug Administration (FDA) has granted conditional approval to start a trial testing a new treatment to reduce the incidence of new onset postoperative atrial fibrillation.

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September 23, 2010 – The U.S. Food and Drug Administration (FDA) has conditionally approved the first part of a trial testing a new transcatheter heart valve.

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September 23, 2010 - Results from the second stage of a trial studying a bioresorbable vascular scaffold were announced at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C.

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September 23, 2010 – The United States District Court for the District of New Hampshire entered a permanent injunction in a patent infringement lawsuit between two medical device companies.

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September 23, 2010 - Results from a study evaluating the safety and clinical efficacy of the Promus Element everolimus-eluting coronary stent will be released at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C.

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September 23, 2010 - The first-in-human procedure to use ultrasound therapy to treat mitral regurgitation (MR) has been successfully completed. The data from the study, which used ReCor Medical’s ultrasound therapy, will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting in Washington, D.C.

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September 23, 2010 – The first consensus document for treating structural heart disease has been published by the Society for Cardiovascular Angiography and Interventions (SCAI).

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