OEC 9800 MD Digital Imaging System
In March 2003, GE Medical Systems (Salt Lake City, UT) received FDA clearance for its OEC 9800 MD, a digital mobile imaging system with a fully motorized C-arm that allows physicians to position the system easily and create images of vascular anatomy with exceptional detail during endovascular procedures. GE Medical states that the system’s new fully motorized C-arm allows a single user to control the system at the tableside, which helps optimize the valuable staff and resources in the cardiac cath lab or surgery suite.
Among the OEC 9800 MD’s features are 1k X 1k digital resolution, a tableside user interface, a collision protection system, heat management and output, and DICOM 3.0 compatibility. The company estimates that the system will be commercially available by late-Summer 2003.
Company: GE Medical Systems
Phone: (800) 874-7378
• 1k X 1k image resolution
• Fully motorized C-arm movements
• Tableside user interface
• Collision protection system
Zenith AAA Endovascular Graft
On May 23, 2003, Cook Incorporated (Bloomington, IN) received FDA clearance to sell its Zenith AAA Endovascular Graft System in the US. The Zenith AAA Endovascular Graft with the H&L-B One-Shot Introduction System is a third-generation endovascular graft system with more than 10,000 implants worldwide. It features a bifurcated modular system consisting of self-expanding stainless steel z-stents and woven polyester graft material.
The main body of the graft incorporates a suprarenal stent and is introduced via the H&L-B One-Shot Introduction System. The contralateral and ipsilateral iliac legs are introduced via their respective H&L-B One-Shot Introduction Systems. Both iliac legs are docked into the main body to form two adjacent channels. The main body is available in diameters of 22 mm to 32 mm and iliac legs in diameters of 8 mm to 24 mm. Ancillary components are also available for Zenith AAA procedures. These ancillary components include aortic main body extensions, iliac leg extensions, converters and occluders.
Company: Cook Incorporated
Phone: (800) 457-4500
• Suprarenal fixation
• Modular design
• Low iliac attachment
• Woven polyester
• H&L-B One-Shot introduction system
Vaxcel Ports with PASV Valve Technology
Boston Scientific Corporation (Natick, MA) recently launched the Vaxcel brand of implantable ports with PASV Valve Technology. The PASV Valve is designed to close automatically after infusion, disconnection, or aspiration, and remain closed during normal pressure fluctuations. The technology automatically resists backflow and has been shown to reduce the incidence of occlusive or infectious complications. The Vaxcel Port body style features significant septum-to-profile ratios that facilitate access and enhance patient acceptance. Improvements to the body designs include plastic, low-profile options, a redesigned locking mechanism, and marked catheters with enhanced radiopacity. The product is designed for long-term vascular access, allowing for the administration of IV fluids, medications, parenteral nutrition solutions, and withdrawal of blood products.
Company: Boston Scientific Corporation
Phone: (800) 225-3238
• PASV Valve Technology is designed to reduce risk of infection and occlusion
• Unique proximal valve location isolates the valve from the bloodstream
• Large septum area facilitates palpation and access
• Low-profile design options enhance patient acceptance and comfort
• Twist-on locking collar is designed to attach securely to a new barbed port stem
QuickSeal Arterial Closure System
Sub-Q Inc. (San Clemente, CA) designs, manufactures, markets, and distributes mechanical closure devices for the femoral artery. The QuickSeal Arterial Closure System is a minimally invasive, extravascular femoral arterial closure device for use in interventional or diagnostic procedures. Sub-Q states that QuickSeal is the only device that incorporates a resorbable porcine gelatin sponge, a proven hemostatic material used in surgery for more than 50 years, and deploys over-the-wire to ensure accurate delivery. The company further states that the device’s extravascular nature allows it to be used on a broader array of patients than many vascular closure devices, including patients with peripheral vascular disease (PVD). Additionally, the simple, intuitive, over-the-wire design assists precision placement of the gelatin sponge and the extravascular deployment avoids limitations of vascular anatomy.
The QuickSeal Device provides very low clinical complication rates similar to manual compression, without the associated hold time. Results following a US randomized clinical trial on the use of the QuickSeal device showed a statistically significant decrease in time to hemostasis and time to ambulation for diagnostic and interventional patients. The QuickSeal System is FDA approved and available for sale in the US. n
Company: Sub-Q Inc.
Phone: (949) 369-5751
• Extravascular device allows for treatment of patients with PVD
• Rapidly resorbable porcine gelatin sponge
• No femoral angiogram required
• Low complication rates
• Reduced time to hemostasis and ambulation