Boston Scientific’s Agent™ Paclitaxel-Coated PTCA Balloon Catheter has gained CE mark approval and will now be launched in Europe.
Approval/Clearance
FDA Approves Sorin’s Solo Smart™, First Stentless Fully Biological Valve
Italian cardiovascular device maker Sorin Group, has gained U.S. FDA approval for the Solo Smart™ Aortic Pericardial Heart Valve which the company claims is the first biological valve to feature a fully removable stent.
FDA Clears 150 cm Arrow® GPSCath® Balloon Dilatation Catheters
Teleflex subsidiary Hotspur Technologies has gained FDA clearance for its 150cm length Arrow GPSCath dual function balloon dilatation catheters.
Newly Approved Prestige® LP Moves Cervical Disc Game On
Medtronic has based its new device on the design principles of its successful predecessor, but a few changes of approach and material represent evolutionary steps.
FDA Clears PicoSure™ for Treatment of Acne Scars
Cynosure, Inc., has received FDA 510(k) clearance for its flagship PicoSure Picosecond Laser Workstation for the treatment of acne scars.
Sorin’s Phospholipid-Reducing Crown Valve Gains CE Mark
Cardiovascular device specialist Sorin Group, has gained CE mark certification for its innovative CROWN PRT™ stented aortic bioprosthesis.
CE Mark and First Use of St. Jude’s FlexAbility™ Ablation Catheter
St. Jude Medical, Inc. has gained CE Mark approval and announced first use of the FlexAbility™ Ablation Catheter, a novel ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias.
FDA Clears FLXfit™, The World’s First 3D Expandable Interbody Cage
Expanding Orthopedics Inc., has announced that its FLXfit™, the world’s first 3D expandable interbody cage, has gained U.S. FDA 510(k) clearance for commercialization in the US.
FDA Approves Boston Scientific’s REBEL™ Coronary Stent
U.S. FDA approval of REBEL™ Platinum Chromium Coronary Stent brings the benefits of modern stent architecture to patients not suitable for drug eluting variants.
Now FDA Clear CorMatrix® ECM® for Vascular Repair
CorMatrix Cardiovascular has extended the application of its CorMatrix® ECM® having received U.S. FDA clearance to market the material for Vascular Repair.
FDA 510(k) Clearance for VICTUS® Femtosecond Laser use in Lens Fragmentation
Bausch + Lomb has gained FDA 510(k) clearance for use in laser-assisted lens fragmentation during cataract surgery.
Covidien Targets Accurate Liver Tumor Ablation with Emprint™ System
Covidien plc has unveiled an advanced ablation system that offers physicians predictable results regardless of the target location or tissue type.
Boston Scientific Plugs TAVI Gap with CE Mark for 25 mm Lotus™
Boston Scientific’s Lotus™ TAVI System has been enhanced by the addition of a 25mm variant to its CE marked portfolio.
CE Mark for Boston Scientific’s Ranger™ Drug-Coated Balloon
Boston Scientific Corporation has received CE Mark for the Ranger™ Paclitaxel-Coated PTA Balloon Catheter which is now to be fully launched in Europe.
FDA Clears Titan Spine’s Endoskeleton® TL Device for Lateral Spinal Fusion
Titan Spine’s newly cleared Endoskeleton® TL system utilizes a lateral approach and represents the first lateral fusion device to features the company’s implant surface technology.
New IDE Study: Will Vici Stent Conquer Venous Stent Market?
The U.S. FDA has given the go ahead to Veniti’s Vici Venous Stent system which the company says is the first to be designed specifically for venous use.