Following on the heels of its non compliant forebear, the Euphora semicompliant coronary balloon offers enhanced pushability
Approval/Clearance
Early CE Mark for STENTYS’ Next-Generation Self-Apposing Stent System
“Quantum Leap” in design means Self-Apposing stent delivery now mimics conventional stent placement, says the company
CE Mark for BONESUPPORT CERAMENT™|V, Injectable Vancomycin-Eluting Bone Substitute
First Injectable Vancomycin Eluting Bone Substitute in the Management of Osteomyelitis gains regulatory approval in Europe
First-of-its-Kind Approval for Near Vision Corneal Implant
The U.S. FDA has approved the first implantable device for correction of near vision in patients who have not had cataract surgery
U.S. FDA Clearance for Two Pigmented Lesion Treatments
Two new clearances have been announced for technologies to treat a variety of aesthetic treatments
FDA Approval for Only ICD to Deliver Ultra-High Energy on First Shock
Delivering 42 Joules on first shock addresses patients with high defibrillation thresholds
FDA Clears Conventus PH Cage™, MIS Proximal Humerus Fracture Solution
Industry’s first alternative to traditional treatment offers simpler procedure for proximal humeral fractures
FDA Clears Perseon’s MicroThermX® for Laparoscopic Cancer Ablation Procedures
MicroThermX® Microwave Ablation System cleared for laparoscopic ablation procedures using image guidance
FDA Approves CoreValve for Valve-In-Valve Use, Expanding Treatment Options
CoreValve becomes first TAVR device to be indicated for replacement of failed surgical heart valves, expanding the patient population that can benefit from this minimally invasive procedure
FDA Clearance for Wright Medical’s External Fixator
The SALVATION™ external fixation system forms an integral part of Wright’s Limb Salvage product portfolio
FDA Approval for Impella 2.5 in Elective and Urgent High Risk PCI
With this approval, Impella 2.5 becomes the only FDA-approved percutaneous hemodynamic support device for high risk indications
FDA and CE Mark Approval for Boston Scientific’s Thinner S-ICD System
Boston Scientific will be hoping its new S-ICD will prove popular based on its advantages over conventionally placed leads
FDA Approves Medtronic Protégé™ GPS™ Stent for Iliac Artery Stenosis
Supporting study points to 96% nine month patency and 99% freedom from target vessel revascularization
FDA Approves Boston’s WATCHMAN™ Left Atrial Appendage Closure Device
First-Of-Its-Kind alternative to long-term Warfarin therapy for stroke risk reduction in patients with non-valvular atrial fibrillation
CE Mark for Software to Help Diagnose Serial Lesions and Diffuse Coronary Disease
Philips’ newly acquired Volcano business has seen its iFR Scout Pullback software gain European regulatory approval
Otto Bock Claims New Michelangelo® Prosthesis Closest to a Human Hand
The most technologically advanced prosthetic hand in the world is changing the life of a 30 year amputee