Clinical and Industry News, Part 2

Cook Consolidates Drug-eluting Stent Program Cook Inc. is consolidating its U.S. drug-eluting coronary stent programs. As part of its consolidation efforts, Cook is choosing to cancel its PATENCY clinical trial for its Cook Logic PTX drug-eluting coronary stent. Instead, the company will focus its efforts on its ACHIEVE clinical trials for its paclitaxel drug-eluting stent, which it hopes will be launched in 2003. Cook is partnering with Guidant Corporation to bring the drug-eluting stent to market. Guidant canceled further development of the international Action clinical trial evaluating its own drug-eluting stent system utilizing actinomycin-D. Cook will, however, introduce its V Flex Plus PTX drug-eluting coronary stent in Europe using newly developed balloon catheter technology upon approval of its CE Mark submission, which is expected in the second quarter of 2002. Cook will complete its ongoing U.S. clinical trial of the uncoated Logic coronary stent. The company said it also will continue its expedited research and development efforts for future paclitaxel-eluting coronary and peripheral stents for the U.S. and overseas markets. Providence Heart Centers Implement CardioNow’s Image and Information Management Service The Heart Centers of Providence Holy Cross Medical Center (Mission Hills, California) and Providence Saint Joseph Medical Center (Burbank, California) have implemented CardioNow’s Cardiology Image and Information Management Service (IMS) effective March 1st. CardioNow’s Internet-based digital imaging storage and communication service for cardiac images is replacing the use of cine films to capture and record the 2,800 procedures performed annually at these medical facilities. CardioNow’s service provides a secure, offsite central DICOM image repository for angiograms performed in the four cardiac cath labs of the Heart Centers as well as local on-line image storage for recently completed procedures. Cardiologists, referring physicians and other authorized medical professionals affiliated with Providence Holy Cross Medical Center and Providence Saint Joseph Medical Center now have the ability to access their patient’s images from any computer that can connect to the Internet. This capability is expected to increase clinical productivity and further enhance medical treatment provided to cardiac patients. Our expectation is that recorded images will no longer be sequestered on tape that needs to be physically traded or exchanged from one office or another for clinicians to review, said William A. Gifford, MD, Director of the Cardiac Cath Lab at Saint Joseph Medical Center. We expect this new service to provide lab-like decision-making for our surgeons regardless of where they may be working on any given day. We hope that this will represent vastly improved information management of cardiac images over what even the best managed film service can provide. CardioNow provides the only web-based service specifically designed to handle the large file sizes associated with DICOM cardiology procedures. The Providence Heart Centers selected CardioNow’s service to implement digital image management while avoiding the risk of investing in storage equipment with a high obsolescence factor. All hardware, software and a new high-speed gigabit network installed in each facility, as well as all operational issues to maintain the systems, are provided as part of CardioNow’s subscription-based service. Novoste Submits IDE for Arterial-venous Dialysis Graft Trial Novoste Corporation has submitted an investigational device exemption (IDE) application to the FDA for its CORONA System to treat arterial-venous dialysis graft stenosis. More than 220,000 people in the U.S. currently undergo long-term dialysis for end stage renal disease and a majority of these patients rely on arterial-venous dialysis grafts for vascular access. Unfortunately, these grafts are associated with a very low patency rate of 40 percent to 60 percent at one year and many of these grafts require interventional therapy to maintain patency. There is evidence that the stenosis is due to intimal hyperplasia formation at the graft site as a result of turbulent blood flow, increased pressure and cyclical stretching of the vein wall, and therefore may be an ideal target for vascular brachytherapy. The BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) trial IDE, submitted to the FDA for review, will be a prospective, randomized, multi-center, placebo-controlled trial investigating the safety and efficacy of the Novoste CORONA System to treat venous outflow stenosis in arterial-venous dialysis grafts.

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