The Laboratory Services unit of Rheologics has launched a Whole Blood Viscosity (WBV) testing program for physicians. The company specializes in facilitating the study of blood viscosity and its relationship to cardiovascular disease.

The FDA panel that convened for an intense, two-day review of drug-eluting stents last week heard key testimony from clinical experts at both Boston Scientific Corp. and Cordis Corp., the only two interventional device manufacturers in the U.S. that have FDA clearance to market the devices. The panel concluded that, for on-label indications, DES appear to increase the risk of late stent thrombosis but do not increase the risk of death or MI.

A strong grassroots effort among physicians played a key role in staving off a Medicare physician payment cut that would have taken effect Jan. 1, 2007. Over the weekend, the House and Senate voted to eliminate the impending 5 percent payment slash — the legislation provides a zero percent update for 2007, as well as a 1.5 percent incentive payment to physicians who report on quality measures beginning July 1, 2007 through Dec. 31, 2007.

The FDA panel that is re-evaluating the safety of drug-eluting stents convenes Dec. 7 and 8 at the Hilton Washington DC North in Gaithersburg, MD.

The Circulatory System Devices Panel has a full agenda of hearing public and corporate presentations related to the late thrombosis connection with DES. Specifically, the panel is commissioned to address the following questions, according to an FDA Web page:

Questions to the Panel

Circulatory System Devices Panel December 7 and 8, 2006 On-Label Use of DES

FUJIFLM Medical Systems USA, Inc. (“Fuji”) and Problem Solving Concepts, Inc. (“ProSolv”) have announced a co-marketing agreement that will enable the two companies, in the US market, to leverage their respective expertise and the product benefits of ProSolv’s cardiology software and Fuji’s Synapse PACS (Picture Archiving and Communications System) for radiology, to provide physicians with better access to clinical information while at the same time allowing healthcare facilities to better leverage their IT infrastructure investment.

Taking anti-platelet medication longer than current recommendations may lower heart attack or death risks for patients with drug-eluting stents, according to a study funded by the Agency for Healthcare Research and Quality and published this week in the online version of JAMA.

Clopidogrel is currently recommended for three to six months after placement of DES. But the new observational study by AHRQ's DEcIDE Research Center at Duke University suggests the drug reduces risks of heart attack or death for at least two years in some patients, Newswire reports.

Agfa HealthCare has signed a contract with the National Heart Centre (NHC) of Singapore, the national referral centre for cardiovascular diseases and part of the Singapore Health Services (SingHealth) public healthcare cluster. The installation will include Agfa Heartlab Cardiovascular solution, a Web-based cardiovascular information system comprised of image management, structured reporting and a web-based portal.

Phase III of CoreValve’s international trial for its patented 18-French Revalving System is now one-third enrolled since beginning less than three months ago.

The unique 18-F-sized delivery catheter, has been used successfully to percutaneously implant its proprietary porcine pericardial-tissue bioprosthesis over the diseased aortic heart valves of more than 30 patients in a “cath” lab setting. The safety-and-efficacy clinical trial is expected to enroll 100 patients or more at 12 sites in Europe and Canada.

The FDA will revisit a device tomorrow that it cleared for U.S. sale three years ago — drug-eluting stents will be the subject of a two-day, 18-hour meeting of FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee, Dec. 7 and 8 at the Hilton Washington DC North in Gaithersburg, MD.

The committee will discuss and make recommendations regarding issues related to stent thrombosis in coronary drug-eluting stents. Oral presentations from the public are slated throughout the committee’s deliberations on both days.

The FDA was notified on Dec. 2 that Pfizer will suspend a large, Phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality (death) in patients receiving the combination compared to those receiving atorvastatin alone. The agency says it fully supports Pfizer’s decision.

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