Feature | By Glenn W. Laub, M.D. – Defibtech CEO, chairman of cardiac surgery, director of the Heart Hospital, St. Francis Medical Center, Trenton, N.J.

In a crowded Boston North Station, three bystanders waiting for a train heard a man cry out and immediately sprang into action. They removed his shirt, started chest compressions and cleared his airway while a transit police officer ran to get the station’s automated external defibrillator (AED). They shocked the man’s heart with the AED, saving his life.

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November 10, 2009 – Onset Medical Corp. today said it received U.S. FDA 510(k) marketing clearance for its SoloPath TransFemoral Endovascular Access Catheter. It is designed to provide access to diseased arteries at a relatively small catheter size and then is expanded to provide a conduit for the delivery of larger diameter devices.

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November 10, 2009 – Covidien said yesterday it will voluntarily contraindicate the use of its Optimark gadoversetamide injection, a gadolinium-based contrast agent (GBCA), in magnetic resonance imaging (MRI) procedures involving patients with severe renal impairment.

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November 10, 2009 – Clinically, stent fracture has been reported in 1-2 percent of patients after drug-eluting stent (DES) implantation, but researchers at the CVPath Institute Gaithersburg, Md. and? Emory University School of Medicine, Atlanta, say the amount of fractures is actually much higher at about 29 percent.

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November 10, 2009 – Toshiba America Medical Systems, Inc. has introduced the Toshiba Assurance Refurbishment Program to provide customers the ability to purchase previously owned, completely refurbished Toshiba systems.

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November 9, 2009 — Two products from Prescient Medical, the vProtect Luminal Shield and the vPredict Optical Catheter System, will be featured at the third annual Canaccord Adams Cardiovascular Conference.

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November 9, 2009 – Boston Scientific Corp. today announced the launch of its COGNIS cardiac resynchronization therapy defibrillator (CRT-D) and the TELIGEN implantable cardioverter defibrillator (ICD) in Japan.

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November 9, 2009 — PAREXEL International Corp., a global biopharmaceutical services provider, announced today that it has enhanced its cardiac safety capabilities for early-phase clinical development through an alliance with Mortara Instrument Inc., which manufactures and distributes electrocardiogram (ECG) devices and related technology worldwide.

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November 9, 2009 – Boston Scientific Corp. said Friday it reached an agreement in principle with the U.S. Department of Justice (DOJ) related to product advisories issued by its Guidant subsidiary in 2005. The alleged conduct and product sales occurred prior to Boston Scientific’s 2006 acquisition of Guidant.

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November 6, 2009 — Stereotaxis received notice this week that its Celsius RMT ThermoCool catheter received CE mark for distribution in the European market.

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November 4, 2009 – CardioNet Inc. said this week the Centers for Medicare and Medicaid Services (CMS) has not established a national pricing reimbursement rate for mobile cardiovascular telemetry (CPT Code 93229) in the Medicare final rule for the physician fee schedule for calendar year 2010.

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November 4, 2009 — BIOTRONIK Inc. this week announced the results from site preparation, antibiotic use and infection sub-analysis from the REPLACE Registry.

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November 6, 2009 – Edwards Lifesciences Corp. today announced the first successful Japanese implants of a transcatheter aortic heart valve using its Edwards SAPIEN valve. The transfemoral and transapical valve implantations were performed by Osaka University last month in preparation for Osaka’s Senshin-Iryo application submission to the Japanese Ministry of Health, Labour and Welfare.

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November 6, 2009 – Nearly 4 million people nationwide suffer from cardiac arrhythmias each year, according to the 2006 U.S. Cardiac Rhythm Management Market report by Frost and Sullivan. About 2.5 million of these cases cannot be treated or controlled through medication alone.

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November 6, 2009 – Cardiac support device maker Abiomed Inc. yesterday announced second quarter fiscal 2010 revenue of $20 million.

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