LifeStent SDS Stent System
Edwards Lifesciences LLC (Irvine, CA) recently announced the FDA clearance and introduction of its LifeStent SDS Biliary Stent System, part of what will be a full line of LifeStent products. This premounted, balloon-expandable stent has a patented helical design that provides flexibility while tracking and conformability when expanded. The mounted flexibility and small sheath or guiding catheter compatibility contribute to its deliverability. LifeStent SDS Biliary Stent System is available in 6 mm, 7 mm, and 8 mm diameters and in lengths up to 56 mm. The LifeStent SDS Peripheral Stent was also recently introduced in European markets.
Company: Edwards Lifesciences LLC
Phone: (949) 250-2500
• Premounted on 0.035-inch guidewire compatible nylon balloon
• Patented helical design provides flexibility while tracking, and conformability when expanded
• Small sheath or guiding catheter compatibility
LeVeen CoAccess Electrode System
Boston Scientific Corporation (Natick, MA) has introduced the first coaxial radiofrequency ablation device designed specifically for the interventional radiologist. The LeVeen CoAccess Electrode System is designed to be used in conjunction with the RF 3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
This device features an introducer set with an insulated cannula designed to assist in preprocedural planning and lesion mapping. Its sharp echogenic stylet tip facilitates tissue penetration and visualization, and its short, lightweight handle allows gantry clearance during CT-monitored ablations. Boston Scientific comments that the patented umbrella-shaped array of the LeVeen Needle Electrode promotes stable, accurate deployment, and its self-balancing, 1-cm tine spacing is designed to help create a complete, predictable thermal lesion.
Company: Boston Scientific Corporation
Phone: (800) 832-7822
• CoAccess Introducer set with insulated cannula
• Sharp echogenic stylet tip
• Short, lightweight handle allows gantry clearance
• Umbrella-shaped array design with sharp, polished array tips
• Self-balancing, 1-cm tine spacing
• Designed for use with RF 3000 Radiofrequency Generator
GE Medical Systems Information Technologies (Milwaukee, WI) has developed a new cardiac catheterization lab physiological monitoring system call Mac-Lab IT.* The system is designed to acquire, store, and manage clinical data with speed and efficiency. Mac-Lab IT uses an intuitive Windows graphical interface to provide user-defined procedural lists, workflow automation, and configurable electronic documentation. The system also features domain level authentication for password-protected security to ensure patient confidentiality, and the ability to save full-disclosure data to a network or optical disk media. The monitors for Mac-Lab IT offer ultrahigh-resolution (1280 X 1024) color on 18-inch flat panel screens.
*Mac-Lab IT is currently under review for FDA 510(k) approval in the US.
Company: GE Medical Systems
Phone: (800) 558-5120
• Powered by Centricity Cardiology Information Systems
• Secure network protected by password access
• GE x-ray bidirectional interface
• Scheduling module
Quadra-Fuse Multi-Pronged Injection Needle
Rex Medical, L.P. (Conshohocken, PA), recently announced 510(k) Exempt Status and CE Mark approval to market its Quadra-Fuse Multi-Pronged Injection Needle, which is designed for the infusion of fluids (chemicals, hypertonic saline, etc.) into soft tissue. Quadra-Fuse is an 18-gauge stainless steel, multipronged injection needle design (27-gauge needle array) with corresponding array diameters of 1 cm, 2 cm, 3 cm, 4 cm, and 5 cm. The device is available in lengths of 10 cm, 15 cm, and 20 cm (coaxial technique). This technology, combined with an echogenic tip, is compatible with both CT and US imaging modalities. MR-compatible needle designs are currently under development, in addition to Quadra-Fuse ST device technology that will target smaller 1-cm and 2-cm tissue zones.
W. Scott Helton, MD, Professor and Chief, Division of General Surgery, University of Illinois at Chicago, comments, “Quadra-Fuse needle technology provides accurate and uniform distribution of chemical agent into soft tissue along with a significant reduction in procedure time versus single source injection devices.” n
Company: Rex Medical, L.P.
Phone: (610) 940-0665
• Accurate and uniform distribution of chemical agents into soft tissue
• Reduced procedure time
• Compatible with both CT and US imaging modalities