October 28, 2008
Cook Medical Brings Power Injection Capability of Contrast Media to Spectrum(R) Antimicrobial Central Venous Catheter Line
Responding to industry demand for an antimicrobial impregnated central venous catheter capable of withstanding pressure injection rates required for CT scans, Cook Medical has received U.S. Food and Drug Administration 510(k) clearance for a power injectable indication for sizes 7-10 French of its Spectrum(R) Antibiotic Central Venous Catheters, the company announced today.
"Spectrum already represents the most effective device available to help prevent catheter-related bloodstream infections, one of the most widespread and potentially lethal hospital-acquired infections," reported Bruce Gingles, vice president and global leader of Cook Medical's critical care strategic business unit. "Customers have asked Cook for a power injection version of this catheter to avoid the need to insert a second line for contrast."
The FDA clearance includes power injection indications for the distal lumen of adult Spectrum catheters in 7 French, 8 French, 9 French and 10 French diameters. The FDA clearance does not include power injection indications for Spectrum catheters in pediatric sizes.
Central venous catheters (CVCs) such as Spectrum are typically used in approximately half the patients undergoing treatment in a hospital's intensive care unit. In the United States alone, more than 5 million CVCs are used annually, with more than 80,000 patients developing a catheter-related bloodstream infection (CRBSI). Costs associated with treating these preventable infections average approximately $30,000 each, and about 20,000 patients a year die from these systemic infections. Numerous peer-reviewed publications, including a landmark study published in the New England Journal of Medicine, have demonstrated both the safety and superior efficacy of Spectrum Central Venous Catheters in preventing catheter-related bloodstream infections.
On October 1, 2008, Medicare eliminated reimbursement to hospitals for treating CRBSIs and other hospital-acquired infections. Cook Spectrum Antimicrobial Central Venous Catheters are a scientifically proven tool hospitals and clinicians can use to eliminate preventable CRBSI and avoid the risk of Medicare nonpayment.
The Cook Spectrum Antimicrobial Central Venous Catheter is available for immediate delivery in the United States. For more information on Spectrum technology and how it can help reduce infectious disease rates and control health care costs, visit www.cookcriticalcare.com.
About Cook Medical
Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.