The FDA has granted 510(k) Clearance of the American Medical Systems® RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI). The company says its system incorporates enhancements and the ability to make fine-tuned adjustments to better meet the needs of physicians.
Regulatory
CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems
Boston Scientific has received CE Mark approval of its X4 line of quadripolar cardiac resynchronization therapy defibrillator (CRT-D) systems and seen first implantations in Italy.
FDA Clears First Device to Relieve Migraine Headache Pain
The U.S. FDA has cleared the eNeura Therapeutics’ Cerena Transcranial Magnetic Stimulator (TMS), making it the first device to relieve pain caused by migraine headaches that are preceded by an aura.
CE Mark for 25mm Portico Transcatheter Aortic Heart Valve from St.Jude Medical
St. Jude Medical, Inc. has gained CE mark approval for a 25 mm iteration of its Portico™ Transcatheter Aortic Heart Valve Implantation System, extending the applicability of the device to more patients for whom transcatheter aortic valve replacement (TAVR) is indicated.
FDA Clears Ethicon-Endo’s New Harmonic Focus®+ Shears With Adaptive Tissue Technology
Newly cleared Harmonic Focus® + Shears with so-called Adaptive Tissue Technology promise accurate resection with consequent enhanced speed and surgical precision.
Gore® Sees Viabahn® FDA Approval Extended to Include Synthetic AV Access Grafts
W. L. Gore & Associates has seen the FDA extend its indication for the GORE® VIABAHN® Endoprosthesis to include treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic AV access grafts.
Panel’s Yes Vote Means FDA Will Find it Hard to Say No to Boston’s WATCHMAN™ LAA Closure Device
Could the FDA be about to approve a permanently indwelling, percutaneously inserted Left Atrial Appendage closure device? It’s hard to see the agency going against the 13:1 vote in favour from its expert panel.
New FDA Approval Means Larger Target Vessels for Reverse Medical’s Peripheral Vascular Embolizer
Reverse Medical® Corporation has gained FDA 510(k) clearance to market its MVP®-5 Micro Vascular Plug system for peripheral vessel embolization, together with news of the first US clinical case.
Now TYRX Antibacterial Envelope FDA Cleared for Use with Spinal Cord Neuromodulators
TYRX, Inc. has received U.S. FDA clearance to expand marketing indications of its AIGISRx® N Antibacterial Envelope to include use with spinal cord neuromodulators.
CE Mark for AMS RetroArc™ Retropubic Female Stress Urinary Incontinence Sling
American Medical Systems® Inc. (AMS), has announced that its RetroArc™ Retropubic Sling System for treatment of female stress urinary incontinence (SUI) has gained CE Mark approval.
Sorin Group Launches Intensia Family of ICD and CRT-D Devices Featuring DF-4 High Voltage Connector
Italian Cardiovascular device maker Sorin Group has gained CE Mark approval for its INTENSIA family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-D) devices, all of which feature a DF-4 high voltage connector.
Internal Fault Prompts FDA Safety Communication on Philips’ HeartStart Auto Defibrillators
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the US FDA has said in a new safety communication for users of these previously recalled devices.
Class II Recall for Stalling Surgical Robot
Intuitive Surgical has written to customers worldwide, and in the US the FDA has issued a Class II recall notice which contains the instruction that users should contact the company to arrange an inspection visit and repair or replace daVinci robotic surgery device components as necessary to avoid a friction-induced stalling problem.
FDA Approves Trial Expansion of Biotronik’s MRI Compatible Pacemakers
Biotronik, a pioneer in MRI compatible Cardiovascular implants devices, tells us that the US FDA has approved an expansion of its ongoing ProMRI® trial. This will allow inclusion of additional patient cohorts into the study, providing further support for the company’s proposed claims.
FDA Clears BME’s HammerLock® Intramedullary Fixation System Upgrades for Hammertoe Deformities
BioMedical Enterprises (BME), Inc. has announced the FDA clearance of an upgrade to the patent-pending HammerLock® Nitinol Intramedullary Fixation System.
CE Mark and First Implant of Sorin’s KORA 100 MRI-Compatible Pacing System
Italian Cardiovascular device company Sorin has confirmed that it has gained CE Mark approval and seen a first implant of the KORA 100 pacing system, which is MRI compatible.