Cath Lab Digest - October 2007 - (Page 59)

59 FDA Clears HandHeld Injector for Angiographic Imaging SICP’s Signature RCIS Review Course Saturday, October 20, 2007 • Washington Convention Center • Washington, DC Hosted by TCT 2007 • www.tct2007.com P inyons Medical Technology, Inc. announced it has received U.S. Food and Drug Administration (FDA) clearance to market the PowrSyringe Injector™. The PowrSyringe Injector is a one-piece disposable hand-held device that adds ergonomic and mechanical advantages to a highpressure syringe. In angiography, the Injector can increase injection speed without sacrificing user control and tactile feedback. Shawn Fojtik, Pinyons Chief Executive Officer, said, “Increasing angiographic injection speed may improve image quality, enable clinicians to use smaller catheters, reduce contrast, and make it easier to inject. Improving patient care with simple cost-effective devices is our company goal.” According to Pinyons, the PowrSyringe does not require costly new capital equipment. An abstract on the first in-vivo use of the PowrSyringe was presented at the New Cardiovascular Horizons Meeting on September 5, 2007, reporting faster injection speeds than control syringes. Previous studies with electronic power injectors conclude that increasing angiographic injection speeds can reduce contrast usage per procedure and save institutions thousands of dollars in contrast media expense. Reducing contrast media is also associated with a reduction in contrast induced nephropathy (CIN) and acute renal failure. The company is planning further study to determine how the PowrSyringe can be used to improve image quality, reduce contrast usage, reduce patient complications, and improve care. The PowrSyringe Injector’s indication for use is to inject and withdraw fluids from the body including use in angiography. PowrSyringes may be useful in cardiac catheterization, Topics to be Reviewed Registration Deadline Cancellation Policy interventional radiology, vascular surgery, orthopedics, spine, ear nose and throat, and general hospital use where viscous fluids are injected through small devices to diagnose, treat, or enable other medical devices. Pinyons plans to market a family of PowrSyringe devices for angiography, viscous fluid delivery, balloon catheter inflation, discography, vertebroplasty, biopsy, and aspiration. The PowrSyringe Injector is expected to be available for commercial sale in early 2008. U.S. and foreign patents are issued and pending on the PowrSyringe Injector, Monitor, and Aspirator. Pinyons Medical Technology, Inc. has offices in Park City, Utah and Hallandale Beach, Florida. See www.pinyonsmedical.com for more information. ■ Cordis Corporation Introduces Fire Star™ Rx PTCA and Dura Star™ Rx PTCA Dilatation Catheters C ordis Corporation announced the introduction in the U.S. of the Fire Star™ Rx PTCA Dilatation Catheter and the Dura Star™ Rx PTCA Dilatation Catheter. Both balloons, indicated for expansion in the narrowed area of a coronary artery or bypass graft, will be offered to catheterization laboratories and interventional cardiologists starting on Oct. 15. The U.S. FDA approved the commercialization of these products in late August. The Fire Star Balloon features the lowest pre-dilatation profile in the market. It is equipped to enable interventional cardiologists to easily guide the catheter through tortuous arteries and to cross complex blockages. The Dura Star Balloon facilitates the post-delivery expansion of stents in coronary arteries and is also suitable for tackling tortuous arteries and complex blockages. It has been designed to provide controlled and even expansion of the balloon to the correct diameter, which may help reduce the potential for artery damage to the patient. With its low pre-dilatation profile, the Fire Star Balloon is also suitable for use in highly stenosed lesions and bifurcations. In addition, the Fire Star Balloon offers a controlled expansion for accurate dilatation of arteries, which may help reduce the potential for artery damage. It also has a soft and tapered tip to facilitate crossing stent struts and challenging lesions, while its shaft construction helps to reduce the risk of “kinking.” The device is finished with a lubricating coating and is available in various lengths and diameters ranging from 10 mm to 30 mm and from 1.5 mm to 3.5 mm, respectively. The Dura Star Balloon is suited for use with both drug-eluting and bare-metal balloon-expandable stents. Its short and soft tip facilitates crossing stent struts and complex lesions. Designed to reduce the risk of kinking and equipped with a lubricating coating, the Dura Star Balloon provides easy delivery to the site of a lesion, especially in challenging cases. The balloon is available in various lengths from 10 to 30 mm and from 2.25 to 4.0 mm in diameter. ■ http://www.tct2007.com http://www.tct2007.com http://www.sicp.com http://www.sicp.com http://www.tct2007.com http://www.pinyonsmedical.com

Table of Contents Feed for the Digital Edition of Cath Lab Digest - October 2007

Saints Medical Center Fibromuscular Dysplasia in Children and Adolescents Cerebral Vascular Accident Following a Pulmonary Embolism: Search for the Hidden Patent Foramen Ovale Contents Clinical Editor’s Corner Meetings Calendar CEU Education Center Radiation Tracking in the Cardiac Catheterization Lab Letter to the Editor Carotid Stenting: An update Release from Stent-jail: Beneficial Snow-Plowing? Patient Management Guidelines Searching for a Cardiovascular Position? Tips for Creating a ‘Stand-Out’ Resume Long-Term Implications of Short-Term Closure Decisions – The Evolution to Vascular Access Management and the Boomerang Catalyst System The Ten-Minute Interview with… Angie Bowles, RN, CCRN CMS Issues Final FY 2008 IPPS Rule ACVP• Membership Page Experience with a New Workhorse Guidewire Ask the Clinical Instructor: Q&A for Those New to Cath Lab A Glimpse of the Future of Clinical Education: Boston Scientific’s SimSuite Bus Visits Carnegie Institute 2007 Educational Fair Held at the Washington Hospital Center Research Update: Original Contribution Abstracts from The Journal of Invasive Cardiology What Do You Think? A Virtual Cath Lab Viewer (VCL): The Development of an Online 3D C-arm Simulator and Coronary Anatomy Viewer Clinical & Industry News Cost-Effectiveness of the Radial versus Femoral Artery Approach to Diagnostic Cardiac Catheterization

Cath Lab Digest - October 2007

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