C. R. Bard, Inc’s acquisition of Lutonix, Inc will position it well to be the first company to gain FDA clearance for a drug coated PTA balloon in what is estimated could be a $1Bn market.
FDA
Uro/Gyne Surgical Mesh Implants: FDA Updates Position
FDA has announced a heightened degree of scrutiny regarding transvaginally inserted meshes and is considering reclassifying from Class II to Class III.
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.
FDA Steps Up Publicity For Its “Preventing Surgical Fires” Initiative
The article outlines FDA’s recommended measures healthcare professionals could and should take to identify and avoid surgical fire risk.
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.
FDA Provides Info On NeurX Diaphragm Pacing system
Following FDA’s approval under Humanitarian Device Exemption rules of Synapse Biomedical’s NeurX Diaphragm Pacing System in September it has now released further information.
FDA Publishes Further Information Following Approval Of Edwards Sapien Valve
FDA has followed up its approval of Edwards’ Sapien Transcatheter Aortic Valve with information pertaining to the approval and use of the device.
Boston’s WATCHMAN® Device First Patients in Latin America
Boston Scientific’s Innovative Watchman left atrial appendage closure device, a proven alternative to anticoagulant drugs for patients in atrial fibrillation at high risk for stroke, has been implanted for the first time in Latin America.
Stent Shrinkage Still In Spotlight. FDA Wades In.
FDA is taking a proactive stance and working with manufacturers to understand the issue of longitudinal compression in next generation Drug-Eluting Stents.
FDA Reports Growth in Medical Device Adverse Events
Medtech Business reports FDA’s observations that growth in reported serious adverse events has outpaced revenue growth by 8% each year in the past decade.
FDA Advisory Panel Makes Recommendation on Investigational Medtronic Phased RF Ablation System for Treatment of Persistent or Long-Standing Persistent Atrial Fibrillation
Medtronic has announced that the FDA Circulatory Systems Devices advisory panel has voted against the company’s Phased RF Ablation System,