GE Healthcare (Waukesha, Wisconsin) says it is scaling down both the size and cost of big cardiovascular ultrasound equipment with a product that's more accessible to physician offices and imaging centers, launching, at this year's meeting of the American College of Cardiology (ACC; Washington), the mobile Vivid S5 cardiovascular ultrasound system.
The Vivid S5 features stress echo capabilities and raw data digital imaging with console benefits of a full-sized 17 inch LCD monitor, four active transducer connectors and room for on-board peripherals retained in a miniaturized console weighing less than 160 pounds. Standard machines of similar purpose weigh up to 400 pounds and have a larger footprint, according to GE.
"We're now moving our console technology, with the same level of performance into a mid-price range for smaller clinics and doctor's offices," Al Lojewski, global marketing manager for cardiovascular ultrasound technology at GE told Medical Device Daily from the ACC exhibit floor of the meeting.
Vivid S5 costs $60,000 to $90,000, compared to standard models that range in price form $100,000 to $200,000, he said. While the larger units provide 4D imaging, the Vivid model has 2D imaging.
The new system features the "ergonomically friendly" features of its sibling, Vivid S6, according to the company, and Flex-Fit mechanism enables continuous pivoting height adjustment of the control panel, keeping optimal distance from the user and leaving legroom for standing or sitting.
A Flex key, next to the trackball, can be assigned to assume the function of other, more distant keys for minimal effort, increased speed and ease of use. The high contrast wide-angle display monitor includes an auto sensor, automatically adjusting brightness, contrast and gamma levels for environment light, ensuring minimal eyestrain.
In other news from the ACC:
• Data showing strong clinical efficacy for Medtronic (Minneapolis) Endeavor drug-eluting stent were presented. Entitled "One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus Taxus in de novo Native Coronary Lesions," the study featured an analysis of 477 diabetic patients from the ENDEAVOR IV clinical study a head-to-head comparison of the Endeavor and Taxus stents, from Boston Scientific (Natick, Massachusetts) in 1,548 patients.
"Performance of drug-eluting stents in diabetic patients is scrutinized by doctors because diabetes complicates so many aspects of the angioplasty procedure. Achieving good efficacy is more difficult, and safety concerns are significantly increased." said Jeffrey Popma, MD, director of Invasive Cardiovascular Services, Caritas Cardiovascular Center for the Caritas Saint Elizabeth's Medical Center (Boston), and director of the core lab that performed the angiographic analysis for the ENDEAVOR clinical program, including ENDEAVOR IV.
Launched in the U.S. in February and available in more than 120 countries, the Endeavor indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of length = 27 mm in native coronary arteries with reference vessel diameters of = 2.5 mm to = 3.5 mm.
Also presented at the meeting were the findings from two sub-studies from the ENDEAVOR IV clinical trial. One analysis, "The Impact of Mandatory Angiographic Follow-up on the One-Year Clinical and Angiographic Results From Endeavor IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System vs. Taxus in De Novo Native Coronary Lesions," illustrated the artificial impact of routine angiography on revascularization rates.
A second sub-analysis, "The Fate of Side-Branches Among Patients Treated With Zotarolimus-Eluting and Paclitaxel-Eluting Stents: An ENDEAVOR-IV Substudy," looked at side-branch occlusion post-stenting. The analysis was conducted as doctors seek to explain the significantly increased rate of periprocedural MI with Taxus when compared to Endeavor observed in the ENDEAVOR IV clinical trial.
ENDEAVOR IV is evaluating 1,548 patients at 80 clinical centers in the U.S., with a primary endpoint of Target Vessel Failure (TVF) at nine months; a secondary endpoint of Major Adverse Cardiac Events at 30-days.
• Boston Scientific (Natick, Massachusetts) reported positive two-year results from Abbott's (Abbott Park, Illinois) prospective, randomized, single blind, non-inferiority SPIRIT II Trial comparing the safety/efficacy of the Promus Everolimus-Eluting Coronary Stent the Boston Sci brand name for the Xience stent and Taxus Express2 Paclitaxel-Eluting Coronary Stent System in 300 patients in Europe.
Boston Scientific notes that it offers two distinct drugs on two deliverable platforms: the Taxus and Promus Stents.
At two years, results from the SPIRIT II trial demonstrated no numerical difference between the Xience V/Promus and the Taxus in their angiographic outcomes, nor were there statistically significant differences in the clinical outcomes.
Xience is currently pending approval by the FDA, expected in the first half of 2008.
Early results of the SPIRIT II study showed that the Xience V stent was superior to the Taxus stent in six-month findings on angiography and trended better on one-year clinical outcomes.