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.
Approval/Clearance
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.
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.
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.
CE Mark for eZono 4000 Tablet Ultrasound System with eZGuide
German “tablet” ultrasound specialist eZono AG, has received CE marking for its eZono 4000 system, with eZGuide, a revolutionary needle guidance technology.
CE Mark for Extra Large Sizes of Sorin’s Perceval™ Sutureless Aortic Valve
Last week we covered the news that Italian cardiovascular outfit Sorin had gained CE mark approval for its Solo Smart stentless heart valve. Now the company tells us it has also gained the European nod for the large sizes of its sutureless Perceval valve.
FDA Approval for Boston’s Promus Premier™ “Next Generation” Drug Stent
Boston Scientific has followed its July CE mark approval of the Promus Premier drug eluting stent, with a newly announced FDA approval. The company claims “next generation” status, based on enhancements in stent design and delivery system.
KCI Joins Portable NPWT Race with Next Generation V.A.C.Via™ Therapy System
The US FDA has cleared V.A.C.®Via™ Negative Pressure Wound Therapy System from Kinetic Concepts, Inc., featuring a diaphragm pump for faster draw down, longer battery life and higher leak rate threshold than its forebear.