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.

The American Heart Association has published a report demonstrating that adolescent boys have a significantly increased risk of high systolic blood pressure compared to adolescent girls. That fact may account for the higher prevalence of adult hypertension among men compared to women identified in previous studies, researchers report in “Circulation: Journal of the American Heart Association.”

One of the major dilemmas faced by clinicians in the Intensive Care Unit (ICU) is the determination of volume status and the predictability of the response to volume administration. Many of these patients are also hypotensive and in need of hemodynamic assessment. The evaluation of the hemodynamic status is often complicated by body habitus and medical condition. Previous methods of monitoring include echocardiography and the placement of a pulmonary artery catheter.


Pulse oximetry, which directly monitors the patient's oxygenation, came into its own as standard medical practice 20 years ago. It was about that time that its companion application, capnography, was first introduced to the medical community in the U.S.
Capnography continually and instantaneously monitors a patient's carbon dioxide concentrations in respiratory gases and is an indirect monitor of oxygenation that helps in the diagnosis of hypoxia so that corrective measures can be taken.

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