Clinical and Industry News

ChloraPrep® Extends Product Line with New Hi-Lite Orange Tint

Medi-Flex announced an extension of its Chlora Prep® patient preoperative skin preparation line with the addition of new Hi-Lite Orange tinted applicators. The tint gives the surgical team assurance that the site has been prepped, while still allowing visualization of the skin.

The new ChloraPrep tint is available in three applicator sizes: 3 mL, 10.5 mL, and 26 mL. Medical professionals can request free samples by calling 800-523-0502.

ChloraPrep®, including the new tinted product, is a one-step patient preoperative skin preparation. It delivers precise volumes of tinted ChloraPrep solution in an applicator that keeps the hands away from the procedural site and also provides a gentle friction scrub to help penetrate deeper into the dermal layers. The new tinting technology adds the Hi-Lite Orange tint to the ChloraPrep solution as it passes into the sponge pad so the prepped site is easy to see. ChloraPrep is a 2 percent chlorhexidine gluconate and 70 percent isopropyl alcohol skin preparation available in multiple applicator sizes for use in a variety of vascular and surgical procedures. One application of ChloraPrep exceeds the FDA criteria for a patient preoperative skin preparation. ChloraPrep acts rapidly against both gram-positive and gram-negative bacteria. In contrast, traditional iodophors can take two to three minutes until their antibacterial properties take effect. Additionally, ChloraPrep prevents the regrowth of microorganisms on the skin for 48 hours and maintains its effectiveness in the presence of blood and organic matter.

The American College of Cardiology Foundation's NCDR Creates Acute Coronary Syndrome Outcomes Network to Measure and Improve Patient Care

The American College of Cardiology Foundation's National Cardiovascular Data Registry (NCDR) will launch a new initiative to improve safety and outcomes for patients with Acute Coronary Syndrome (ACS). This initiative will combine the data collection and quality reporting features of two national ACS registries to create the largest and most comprehensive national cardiovascular patient database ever developed. The NCDR-ACTION Registry will establish a national standard for understanding treatment patterns, clinical outcomes, drug safety, and the overall quality of care provided for ACS patients.

The NCDR-ACTION Registry (Acute Coronary Treatment and Intervention Outcomes Network) will launch January 1, 2007. The NCDR-ACTION Registry represents the combination of:

The National Registry for Myocardial Infarction (NRMI), an observational study sponsored by Genentech, Inc., and

CRUSADE, a quality improvement program coordinated by the Duke Clinical Research Institute (DCRI) and sponsored by Schering Plough and Bristol-Myers Squibb Sanofi Partnership.

Over the past ten years, more than 1,700 US hospitals have participated in one or more separate ACS-based quality improvement efforts led by NRMI, CRUSADE, and the NCDR. The new partnership between NCDR and DCRI will integrate myocardial infarction data from hundreds of hospitals across the country into one unified platform with standardized clinical data elements to benchmark outcomes, analyze treatment and call attention to quality improvement opportunities. DCRI will also provide research and analytical support for the NCDR flagship registry, the NCDR-CathPCI Registry.

Visit www.accncdr.org or call 800-257-4737 for more information.

About the National Registry of Myocardial Infarction (NRMI). The National Registry of Myocardial Infarction (NRMI), sponsored by Genentech, Inc. is one of the largest observational studies of acute myocardial infarction (AMI). Since 1990, NRMI has collected data on more than 2.5 million AMI patients, and helped more than 1,700 participating hospitals assess their approach to AMI treatment and identify trends in patient outcome. It is not a controlled randomized clinical trial. It does not test effectiveness between therapeutic interventions, and therefore comparisons of outcomes across treatment groups must be treated with caution.

About the DCRI. The DCRI is a full-service academic (contract) research organization. In addition to spearheading large, randomized clinical trials, the DCRI is recognized both nationally and internationally a leader in many areas of outcomes research, including large registry analyses, quality improvement initiatives, and cost effectiveness and quality of life assessment.

Terumo Interventional Systems Launches Two New Micro Access Systems

Terumo Interventional Systems, a strategic business unit of medical device manufacturer Terumo Medical Corporation, has introduced a new line of micro access systems the Glidewire® Access System and the GlideAccess System.

These micro access systems offer less invasive initial puncture and facilitate smooth vascular access. This provides physicians with the ability to introduce the larger devices necessary to complete a wide range of endovascular procedures.

These systems allow the practitioner a choice of three guidewires: Glidewire®, platinum-tipped nitinol, or stainless steel; two sizes of coaxial dilators: 4 Fr or 5 Fr; and three needles: SURFLO® I.V. catheter, echogenic, or non-echogenic.

For more information, customers can contact Terumo by calling its Inside Sales Customer Care Team at 800-862-4143 or by visiting www.terumo medical.com/interventional.

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