Cardio

Results from the St Jude sponsored ASSERT study has found that pacemaker patients who have no history of atrial tachycardia (AT) or AF, but do have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.

Results from “high-surgical-risk” study arm of MitraClip EVEREST II trial suggest the device does provide limited reduction in mitral regurgitation in patients for whom surgery is not an option.

Heartwire (theheart.org) has reported on a study summarising “real-world” experiences with AF Ablation and found patient factors and hospital procedure volume to be determinants of post-operative complications and rehospitalisation.

Cook Medical, is to invest up to €16.5m over four years creating highly skilled positions in Research and Development activities at its Limerick site, with Government support through IDA Ireland.

Texas based AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe.

St. Jude Medical, Inc. has announced that it has met a stopping rule in its RESPECT clinical trial and is closing patient enrollment. The company expects to present its findings during 2012.

First large-scale pacemaker study shows significant reduction in hospitalisations for atrial arrhythmias and related stroke with BIOTRONIK Home Monitoring®

St. Jude Medical, Inc. has launched a Riata Lead Communication website to provide physicians with a compilation of important communications and updated information regarding the recent Riata® and Riata® ST Silicone Defibrillation Leads Class I recall.

STERIS Corporation and Toshiba America Medical Systems, Inc.have formed an alliance to offer advanced vascular, cardiovascular, pediatric and neurosurgical hybrid surgical suites.

Boston Scientific’s Promus Element Drug Eluting Stent was approved by FDA in late November and now the agency has demanded that the company includes a warning on its packaging about the risk of stent shrinkage.

First and Only System in the United States Approved to Treat Patients with Persistent and Long-Standing Persistent Atrial Fibrillation

A malpractice lawyer is accusing Dr John Wang (Union Memorial Hospital, Baltimore, MD), a member of the committee tasked with stopping improper stenting in Maryland, of improper stenting in his own practice.

California-based Magnetecs Corporation has reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.

12 months after European regulators issued alerts, St. Jude Medical, Inc. has now announced that following its voluntary medical device advisory letter to physicians from Nov. 28, 2011 the U.S. Food and Drug Administration (FDA) has now classified this action as a Class I Recall.

Kensey Nash Corporation and St. Jude Medical will enter into non-binding mediation in an attempt to resolve disputes over royalty payments to Kensey Nash relating to the Angio-Seal vascular closure device, as well as other related claims.

St. Jude Medical, Inc. has announced the first implant of its Portico^™ transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval.