Maquet Cardiovascular received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE mark approval for its new Sensation Plus 7.5 French 40 cc intra-aortic balloon (IAB) catheter. This new larger-volume, fiber-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy “at the speed of light” to smaller patients.

W. L. Gore & Associates (Gore) responded to initial results reported in St. Jude Medical Inc.’s RESPECT clinical trial. The RESPECT study investigated whether transcatheter closure of patent foramen ovale (PFO) using St. Jude’s Amplatzer PFO Occluder device is safe and effective compared to best medical therapy in the prevention of recurrent cryptogenic stroke. Gore is concurrently conducting its Gore REDUCE Clinical Study using both the Gore Helex Septal Occluder and, as reported earlier this week, the new Gore Septal Occluder, in patients with PFO and a history of cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA).

ST. Jude Medical PressureWire FFR Catherter

St. Jude Medical Inc., a global medical device company, announced that fractional flow reserve (FFR)-guided treatment using PressureWire was cost effective for coronary interventions when compared to the best available medical therapy. Cost utility analysis data from the FAME II trial was presented as a late-breaking clinical trial at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
DESolve Nx Pivotal Trial Bioresorbable Coronary Stent Elixir Cath Lab

Elixir Medical Corp. announced enrollment completion of the 120-patient, pivotal clinical trial evaluating the safety and efficacy of the DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System. The scaffold is designed to resorb in the body within one to two years after implantation and return the patients’ coronary vessel to de novo state.

The Philips IntelliSpace Portal is an advanced visualization solution designed to simplify the way radiologists work, think and care for patients by delivering on the promise of real-time radiology.

October 29, 2012 — At RSNA 2012, GE Healthcare will unveil innovations in healthcare IT, including enhancements to Centricity PACS (picture archiving and communication system) and PACS-IW. The PACS-IW system aligns advanced visualization, breast imaging and intelligent tools with a unified desktop.

Boston Scientific Corporation has received regulatory approval to market the Reliance 4-Front lead, its next generation implantable defibrillation lead now available in Europe and Asia. Defibrillation leads are insulated wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator to the heart for treatment of heart failure and sudden cardiac arrest.

October 29, 2012 — Brainlab released Buzz Digital OR, a major step forward in information integration for the surgical suite. Buzz encompasses a vast spectrum, from pure DICOM viewing to complete digital operating room (OR) functionality, including video management and documentation.

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