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May 18, 2015

GE Healthcare's Visipaque Use During Angioplasty Shown to Reduce Risk of Adverse Events

May 19, 2015—GE Healthcare announced that data from abstracts presented at EuroPCR show that significantly fewer renal and cardiac events are associated with angioplasty procedures using the company’s isosmolar contrast medium (IOCM) agent Visipaque (iodixanol) than with those using low-osmolar contrast media (LOCM). The EuroPCR 2015 conference is being held May 19–22 in Paris, France.

The abstracts are based on a study funded by GE Healthcare that analyzed data from 334,001 angioplasty procedures from the Premier hospital database in the United States.

According to the company, after controlling for patient demographics, comorbid conditions, year, hospital characteristics, and variations using the hospital fixed-effect specification method, the results showed 10.5% fewer major adverse renal and cardiac (MARC) events when Visipaque was used compared to LOCM (P < .01). Those hospitals that only used IOCM or LOCM observed an even greater benefit with 26.7% fewer MARC events in the group receiving IOCM compared to LOCM. Also, there were 2.7% fewer renal failure events and 0.6% fewer kidney injury events with use of IOCM compared to LOCM.

As summarized by the company, this extensive retrospective study is based on patient billing, hospital cost, and coding history data collected between January 2008 and September 2013. Investigators evaluated 334,001 angioplasty procedures. IOCM was used in 30.8% of cases, and the angioplasty procedures that used Visipaque were in older patients (66.8 years vs 63.8 years; P < .01) and sicker patients based on the Charlson Comorbidity Index (4 vs 3.4; P < .01). IOCM was also used in more emergency procedures and with more patients who were classified as major or extreme on the 3M APR-DRG (All Patient Refined-Diagnosis Related Group) mortality and severity indexes than LOCM. Visipaque was more frequently used in angioplasty procedures among the elderly and more critical patients as measured by the Charlson Comorbidity Index, noted the company.

In GE Healthcare’s press release, Peter McCullough, MD, commented, “The results of this study are highly encouraging and support the use of isosmolar contrast media in high-risk percutaneous coronary intervention. These data suggest that prior studies with signal of reduced risk of contrast-induced acute kidney injury with Visipaque do indeed translate into a reduction in clinically meaningful MARC events.” Dr. McCullough is Vice Chief of Medicine at Baylor University Medical Center in Dallas, Texas.

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May 19, 2015

FDA Approves Silk Road Medical's Enroute Transcarotid Stent System

May 19, 2015

FDA Approves Silk Road Medical's Enroute Transcarotid Stent System