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.
St Jude
St. Jude Completes Enrollment In “RESPECT” PFO Occlusion Trial.
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.
St Jude Launches Website Dedicated To Riata Silicone Lead Management
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.
FDA Wants Shrinkage Warning on Boston Scientific’s Newly Approved Promus Element™ Stent
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.
St Jude Riata Voluntary Recall Judged By FDA as Class 1
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.
Angio-Seal Disputes: Kensey Nash And St. Jude Medical Agree To Mediation
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.
First Implant in St Jude Portico Transcatheter Aortic Heart Valve European Trial
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.
CardioMEMS Trial: Device “Incredibly Compelling” But Concerns About Bias.
CardioMEMS nurse interventions thought by FDA panel to have introduced bias to randomised trial.
CardioMEMS Device Safe According To FDA Panel, But Effectiveness Questioned.
A U.S.FDA panel has decided not to recommend CardioMEMS implantable heart device for treating heart failure because supporting clinical research may have been biased by human intervention.
First UK patients receive MRI-compatible pacemaker
Medtech Business has reported that a cardiac pacing system designed for safe use during magnetic resonance imaging (MRI) scans has been implanted in UK patients for the first time.
Kensey Nash’s Bioadhesive Tendon Repair Grant
Kensey Nash Corporation has been awarded a two-year, $1.9 million grant to investigate the use of a bioadhesive surgical mesh for applications in tendon repair procedures.
St. Jude Medical Expands US Hospital Access to Wireless Fractional Flow Reserve Technology
St Jude’s cooperation agreement with Philips offers more US hospitals access to the market’s only wireless FFR system
St. Jude Medical Announces FDA Clearance of First and Only Combined FFR and OCT System
Following its launch in Europe earlier this year, St Jude’s Ilumien OCT/FFR Coronary Artery Disease diagnostic tool
St. Jude 3rd quarter earnings call: Medtronic sparks Starks criticism
St Jude CEO Daniel Starks blasted rival Medtronic in 3rd quarter earnings call.
St. Jude Medical Announces First Use of Renal Denervation Technology
St. Jude Medical, Inc. has announced the first use of the company’s renal denervation catheter and generator system, as part of a feasibility study of the new technology.
St. Jude Medical Announces Approval and Market Launch of New Neurostimulation Lead to Manage Chronic Pain in Japan
St Jude’s Penta surgical lead is designed to help patients with complex pain patterns such as low back pain