Tag-Archive for ◊ cardiovascular devices ◊

• Friday, October 18th, 2013

St. Jude Medical Reports Third Quarter 2013 Results ST. PAUL, Minn.–(BUSINESS WIRE)–St. Jude Medical, Inc. (NYSE:STJ) today reported sales and net earnings for the third quarter ended September 28, 2013. Third quarter highlights: Net sales increased by approximately 3 percent on a currency neutral basis from the third quarter of 2012 Completed the acquisition of […]

• Wednesday, August 21st, 2013

The United States Solicitor General files an amicus brief effectively siding with Medtronic, arguing that Boston Scientific bears the burden of proof in a long-running patent infringement beef that’s headed for the Supreme Court. Medical device giant Medtronic (NYSE:MDT) may have a little muscle on its side after the U.S. Solicitor General effectively backed the […]

• Tuesday, August 20th, 2013

The FDA issues its highest-risk Class 1 recall for blood kits made by Hospira after 1 patient’s death was deemed partly due to delayed treatment after the piercing pin in the kit punctured the outer wall of the blood bag. The FDA issued a Class I recall on blood kits made by Hospira (NYSE:HSP) after […]

• Monday, July 22nd, 2013

Technology giant Philips Healthcare (NYSE:PHG) issued an urgent recall notice on several lots of its HeartStart MRx monitor/defibrillator systems after 2 patients were harmed. The FDA gave the recall a Class II label, reserved for “products that might cause a temporary health problem, or pose only a slight threat of a serious nature.” The FDA noted and Philips confirmed that […]

• Monday, July 22nd, 2013

MILAN–(BUSINESS WIRE)–July 15, 2013 — Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today the signing of a supply agreement for the manufacturing of certain components of the Lotus Aortic Valve System, Boston Scientific Corporation’s second-generation TAVR (Transcatheter Aortic Valve Replacement) technology. […]

• Friday, July 19th, 2013

Minnesota medical device titan Medtronic recalls certain lots of its Consulta and Syncra CRT-P implants after discovering a manufacturing issue that could “compromise device functionality.” Medical device giant Medtronic (NYSE:MDT) is asking hospitals to return certain cardiac resynchronization therapy pacemakers (CRT-Ps) after the company discovered manufacturing issues that could keep the devices from functioning properly. Medtronic recalled […]

• Wednesday, July 17th, 2013

Boston Scientific Launches Guidezilla Guide Extension Catheter in U.S. and Europe NATICK, Mass., July 12, 2013 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration 510(k) clearance and CE Mark approval for the Guidezilla Guide Extension Catheter and has launched the device in the U.S. and Europe. The Guidezilla device is designed […]

• Tuesday, July 16th, 2013

Medtronic says a German court ruled that its CoreValve replacement heart valve infringes an Edwards Lifesciences patent, forcing it to cede the German market to Edwards and its Sapien valve. Medtronic (NYSE:MDT) said a German court handed it a loss in its long-running patent battle over replacement heart valves with Edwards Lifesciences (NYSE:EW). The Fridley, Minn.-based medical […]

• Monday, July 08th, 2013

Boston Scientific says that patients experienced fewer major complications with the subcutaneous implantable defibrillator compared with transvenous ICDs. Boston Scientific (NYSE:BSX) touted the results of a comparative analysis of patients treated with the subcutaneous implantable defibrillator, reporting that its lead-free ICD may be safer for patients. The lead-free S-ICD system, which uses electrodes implanted beneath the skin […]

• Friday, July 05th, 2013

The U.S. Food and Drug Administration on Tuesday disclosed that it has blocked imports of two Medtronic Inc. catheter products after finding that the company failed to prevent microbial contamination, properly certify software and promptly notify regulators of recalls. http://www.law360.com/productliability/articles/452875/fda-bars-medtronic-catheter-imports-amid-serious-miscues