CYPHER Drug-eluting Stent
The CYPHER Sirolimus-eluting Coronary Stent (Cordis Corporation, a Johnson & Johnson company, Miami, FL) recently became the first FDA-approved drug-eluting stent intended to help reduce restenosis of a treated coronary artery. The device consists of a closed-cell stent delivery platform, a polymer, and sirolimus, an antiproliferative drug that is released inside a vessel in small quantities during the first 30-45 days after implantation. Sirolimus is a cytostatic drug that selectively stops cell proliferation by blocking cell-cycle progression, while leaving the cell in a resting but functional state. By stopping cell proliferation without killing the cells, sirolimus minimizes the risk of tissue pathology.
After the approval on April 24, Health and Human Services Secretary Tommy Thompson said, “Today’s approval represents a significant step forward in the treatment of heart disease. Patients who receive this device will need fewer repeat operations to unclog arteries, which can make a real difference in the quality of their lives.”
In SIRIUS, the major US clinical trial of the device, patients who received the CYPHER Stent had significantly lower rates of in-stent restenosis and repeat procedures versus patients who received a conventional bare stent (3.4% vs 35.4% and 4.1% vs 16.6%, respectively) at 9 months. The combined occurrence of repeat angioplasty, bypass surgery, MI, and death was 7.1% for patients receiving the drug-eluting stent, versus 18.9% in the control arm.
Company: Cordis Corporation
Phone: (800) 781-0282
Web: www.cordis.com; www.cypherusa.com
• First drug-eluting stent approved for use in the US
• Associated with reductions in MACE and restenosis
• Extensively evaluated in several major US and international trials
Safety Paracentesis Tray
The Safety Paracentesis Procedure Tray from Merit Medical Systems, Inc. (Salt Lake City, UT), provides the necessary components to perform a paracentesis procedure easily, economically, and with safety options. According to Merit, benefits of the tray include optimal product performance, comprehensive kit components, increased protection from sharps-related injuries, and specially designed packaging. The Safety Paracentesis Procedure Tray includes the new OneStep Centesis Catheter, lidocaine, drapes, povidone iodine, and three shielded needles designed to minimize the risk of accidental needle-stick injuries. The OneStep catheter features a Luer-Lock hub, FEP Teflon material, four large drainage holes, and a smooth, tapered tip.
Company: Merit Medical Systems
Phone: (800) 626-3748
• Optimal product performance
• Comprehensive kit components
• Increased safety from sharps-related injuries
AngioJet Xpeedior 120-cm Catheter
The AngioJet Xpeedior thrombectomy catheter (Possis Medical, Inc., Minneapolis, MN) has been optimized to remove thrombus in 4-mm to 12-mm vessels and is now available in a longer (120-cm) length to accommodate contralateral approaches. The catheter features a tapered tip, a braided shaft for trackability and pushability, and double marker bands for more accurate measurement and visualization. The dual marker bands, which are located 15 mm apart from center to center, help position the catheter and direct the mechanism of action within the vessel. Each of the Xpeedior catheters is 0.035”-guidewire compatible.
Company: Possis Medical
Phone: (800) 810-7677
• Optimized to reduce thrombus in 4-mm to 12-mm vessels
• New 120-cm length for contralateral approach
• Tapered tip and dual marker bands for navigation and visualization
The Innova 4100 (GE Medical Systems, Waukesha, WI) was designed to assist in the minimally invasive treatment of a variety of disorders, including peripheral vascular, cardiovascular, and neurological diseases, and uterine fibroids. Using this large-format digital flat panel x-ray system, physicians can obtain detailed, real-time fluoroscopic images, facilitating navigation of catheters and other devices.
GE Medical states that by converting x-ray signals into digital images at the point of acquisition, the system’s Revolution detector captures information over the full range of typical exposures, enables exceptional image quality with a large field of view, and eliminates the artifacts and distortions of conventional image-intensifier chains. The Revolution detector’s large (41 cm X 41 cm) field of view reduces the number of x-ray images required for a complete study, reducing the amount of x-ray dosage and contrast-dye injections needed. The system’s 3-axis gantry positioner, ergonomically designed tableside user interface, and flexible table provide for enhanced speed, efficiency, and control.
Company: GE Medical Systems
Phone: (800) 886-0815
• True digital image quality
• Facilitates dose management
• Ease of positioning
ACUSON CV70 System
The Ultrasound Division of Siemens Medical Solutions USA, Inc. (Mountain View, CA) has made a new addition to its ACUSON line of ultrasound systems—the ACUSON CV70. According to the company, the ACUSON CV70 cardiovascular ultrasound system offers exceptional image quality, Doppler sensitivity, color-flow sensitivity, and spatial resolution, as well as a variety of features designed especially for highly sensitive IMT studies in the carotids and in the femoral, venous, and brachial anatomies.
The CV70’s DIMAQ integration allows digital acquisition, storage, and review of complete ultrasound exams. Its Axius edge-assisted Ejection Fraction is designed to expedite studies*, and the system’s DICOM 3.0 software provides rapid digital image transfer, including transfer in DICOM format to a CD-RW drive. Physicians can choose from an extensive selection of application-specific transducers, including those designed for carotid and peripheral arteries that reveal intimal medial detail to help assess endothelial function and arterial health.
*The Axius edge-assisted Ejection Fraction feature requires 510(k) review and is not yet commercially available.
Company: Siemens Medical Solutions
Phone: (800) 498-7948
• Extensive variety of application-specific transducers
• Doppler and color-flow sensitivity
• Tissue Harmonic Imaging for difficult-to-image patients
• Rapid image transfer to CD-RW or hard drive using Windows-based system
TZ Medical Neptune Line
TZ Medical Inc.’s (Portland, OR) new Neptune line of seaweed derivatives was designed to expedite hemostasis and reduce postprocedural monitoring for catheter and dialysis procedures. TZ Medical states that the Neptune Disc and the Neptune Pad use calcium alginate to streamline AV sheath removal, and that the products can also be used in conjunction with any mechanical femoral compression device or with manual compression. The Neptune Comfort Band is designed to act as a comfortable pressure band for dialysis patients, as well as to speed the natural clotting process for cases in which blood flow may have been compromised by medication.
The company reports that nurses and patients who have participated in hospital evaluations have responded favorably to the Neptune line. “They’re telling us that hold time is reduced from the typical hour to an average of 15 minutes,” said Byron Zahler, cofounder of TZ Medical. “That means patients are going home sooner and nurses are freed from the bedside. We also got high marks for the natural connection—re-establishing the intimate bond we all have with the sea.”
Company: TZ Medical Inc.
Phone: (800) 944-0187
• Speeds hemostasis
• Can be used in conjunction with manual and/or mechanical compression
• Reduces postprocedural monitoring