With Arthrex in its sights, Dallen Medical’s says its new button/plug dynamic fixation of Syndesmosis offers adjustability and claims its band is easier on surgeons’ hands
Regulatory
CE Mark for PEEK-on-Ceramic Cervical Disc Offers MRI-Friendly Option
Simplify Medical’s non-metal, MRI-friendly Simplify Disc has gained CE mark approval, which means post-op CT/Myelograms can be avoided
Female Fecal Incontinence Balloon Device Cleared for U.S. Market
The Eclipse System is a novel, vaginally inserted balloon system, cleared for use in Fecal Incontinence prevention in adult women
FDA Clears Endoskeleton® TCS Device for Cervical Fusion with Integrated Fixation
Titan Spine has received U.S. FDA 510(k) clearance for its Endoskeleton® TCS, an interbody fusion device for the cervical spine with integrated fixation
3D Printing Helps Biomet Deliver Acetabular Shells That Mimic the Real Thing
With regulatory clearance under its belt, Biomet is now reporting first clinical use of its OsseoTi Porous Technology for total hip arthroplasty
FDA Expands NanoFUSE® DBM Clearance to Include Spinal Fusion
510(k) now includes use with autograft material as a bone graft extender in the posterolateral spine
Japanese Regulatory Approval for Sorin’s MRI Compatible Pacing System
Sorin Group has gained Japanese regulatory approval for its new KORA 100 pacing system with automatic magnetic resonance imaging mode
FDA Approves Aorfix™Plus EVAR Stent, Increasing Proximal Neck Size Options to 36mm
Lombard’s FDA approval for its Aorfix™Plus endovascular stent graft, means its now an option for larger patient target group
Medtronic Enjoys First Fruit of Covidien’s Product Pipeline
Medtronic has received U.S. FDA approval for the Pipeline™ Flex embolization device, recently absorbed into its product catalogue with the acquisition of Covidien.
CE Mark for New Sizes of CoreValve® Evolut™R TAVI Offering
Now available in Europe in 26 mm and 29 mm sizes, Medtronic’s TAVI valves are delivered through a 14 French equivalent delivery system-the lowest profile on the market.
FastForward™ to Better Bunion Correction as FDA Clears 3D Printed Titanium Bone Tether
The U.S. FDA has cleared a key component in MedShape’s FastForward system that permits bunion correction while preserving bony anatomy.
FDA Clears Dedicated Glaucoma Laser from Iridex
Iridex says its Cyclo G6™ Laser System is the first designed solely for use in treating glaucoma and its symptoms.
First Screw-Rod OCT System Cleared for Use of Screws in Posterior Cervical Spine
DePuy Synthes Spine has seen its SYNAPSE™ Occipital-Cervical-Thoracic (OCT) System cleared for expanded indications
FDA Clears CoolSculpting® Therapy for Lower Temperatures/Shorter Treatment Times
Cosmetic treatment technology company ZELTIQ® Aesthetics, Inc., has clinical data supporting its change of treatment parameters
FDA Approves First Flexible-Tipped Cardiac Ablation Catheter
St. Jude’s FlexAbility is the first flexible tipped ablation device for the treatment of cardiac arrhythmias to gain U.S. approval
CE Mark for InspireMD’s New CGuard RX, Carotid Embolic Protection Stent System
InspireMD, Inc. tells us it has received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet™ covered carotid stent technology.