Delivering 42 Joules on first shock addresses patients with high defibrillation thresholds
Products
FDA Clears Conventus PH Cage™, MIS Proximal Humerus Fracture Solution
Industry’s first alternative to traditional treatment offers simpler procedure for proximal humeral fractures
Paradise Returns as ReCor Brings in Funding for New RDN Study
ReCor Medical has announced Series D investment of approximately $15M, which will position it to start a clinical study into its ultrasound-based renal denervation system
U.S. Launch of Medtronic’s HawkOne™ Directional Atherectomy System for PAD
Medtronic says its system, acquired with Covidien, treats all plaque morphologies including severe calcium, while streamlining procedural efficiency
Direct Flow Trial Broadened to Include High Risk Patients and CoreValve® Comparison
FDA’s agreement to trial expansion should tell us whether novel valve design proves itself in competitive setting
FDA Clears Perseon’s MicroThermX® for Laparoscopic Cancer Ablation Procedures
MicroThermX® Microwave Ablation System cleared for laparoscopic ablation procedures using image guidance
Biotronik Launches “Workhorse” Pantera Pro Coronary Balloon Catheter in EU
Company says its new balloon is designed to enhance access to difficult lesions and challenging patient anatomies
Will EU Hospitals Really Move from Single-Use to Reusable Procedure Trays?
The market drivers are seemingly all there, but we doubt procedure packs will have the uptake predicted in this report.
“Aided Visual Inspection” Should be in IFU of Reprocessable Devices, says Camera Company
When the purveyor of a new technology suggests its use should be mandated, we have to raise questions. When its decontamination related, who’s going to argue though?
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
DePuy Synthes Targets Adult Spinal Deformity with Four New Products
It’s AAOS week, an event that sees DePuy Synthes touting four new adult deformity products as well as a new education offering
DePuy Synthes Targets Better Hip Fracture Outcomes with New Nailing System
A combination of design features and reduced procedural complexity underpin claims for the TFNA Nail, launched at AAOS this week
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