Boston’s drug-eluting stents have become the first to gain FDA clearance for use in heart attack patients.
Approval/Clearance
CE Mark For PARADISE™ Ultrasound Transcatheter Renal Denervation System
Initial results of ReCor’s REDUCE First-In-Man clinical study presented at “TRenD 2012” transcatheter renal denervation scientific meeting as company gains CE mark for its PARADISE™ system.
FDA Clears Resolute Integrity™ DES For Coronary Artery Disease Including Diabetes Indication
Medtronic Inc’s Resolute Integrity™ Drug-Eluting Stent for treating coronary artery disease has been approved by the FDA, after studies showed consistent clinical performance among a wide range of patients, including individuals with diabetes.
FDA Clears Two New Clavicle Repair Technologies
Suspension Orthopaedics has gained FDA clearance for some interesting clavicle plates addressing specific problems associated with clavicular fracture.
CE Mark For Edwards INTUITY Valve: Rapid Deployment Through Small Incision
Edwards Lifesciences Corporation, today announced that it has received CE Mark in Europe for its INTUITY Aortic Valve System.
Custom Spine’s Portfolio CE Marked
Custom Spine Inc has gained CE mark approval for all its products.
No Long Guidewire, Less Bruising: FDA Clearance for AngioDynamics NeverTouch Direct™Procedure Kit For Use With the VenaCure EVLT® System
NeverTouch Direct Kit for treatment of Varicose Veins With Fewer Procedure Steps, has gained FDA clearance.
Buying Single-Use Pressure Transducer Could Save Money
This simple in-line transducer could have many applications including diagnosis of compartment syndrome, one of the most costly hazards in Orthopaedics.
Implantable, Programmable Drug Pump Gains FDA Clearance
The Prometra implantable, programmable pump from Medasys, represents the first non-peristaltic drug-infusion device to gain PMA approval. The product is already CE marked and available in selected European countries, with full EU roll-out expected in the next few months.
CE Mark For Implantable Hemodialysis Access Device From Vital Access
Vital Access has its press release nicely in place, but we’d like to know how to contact the company let alone how to buy its new implantable hemodialysis access device.
FDA Approves Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and Cardiac Ablation Generator.
FDA approves cardiac ablation products from St Jude.
Braile Biomédica Launches Transapical Valve In Brazil
Brazilian developers of the Inovare transapical aortic valve are encouraged by the early experience with the device despite a 50% two-year mortality rate.
Wright’s PROPHECY® INBONE® Pre-Op Guides For Ankle Replacement At AAOS.
Wright’s Prophecy® Inbone® Pre-op navigation alignment guide for ankle replacement surgery has gained 510(k) approval and is being launched on a limited basis in USA.
510(k) For Bovie’s Patented J-Plasma™ Technology
Bovie Medical Corporation, has announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery.
CE Mark And Launch For Sorin’s New Pacing, Defibrillation And Left Ventricular Leads
New lead portfolio combined with Sorin Group’s innovative and intelligent devices provide full-featured systems for accurate management of arrhythmias and heart failure
Ranier Receives CE Mark Approval for Cadisc™-C Cervical Spinal Disc
Following Ranier’s earlier CE approval of its lumbar implant, the company has now secured CE Mark approval for its cervical implant, Cadisc™-C.