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Volcano Corporation Message Board

  • truebe1iver truebe1iver Jun 21, 2008 8:50 PM Flag

    VOLC with Novelis

    "Novelis' proprietary technology has potential applications for a number of minimally invasive diagnostic and therapeutic applications in the coronary and peripheral arteries, including the treatment of CTOs. It is estimated there are currently over 200,000 CTOs performed in the U.S., Europe and Japan each year. These procedures, which remain one of the most challenging issues faced by interventionalists today, often fail or take hours to successfully complete due to inadequate visualization. Furthermore, due to the lack of adequate tools for CTO crossing, many interventionalists simply refer patients with CTOs to highly invasive and costly coronary artery bypass grafting (CABG) procedures. The products under development by Novelis have the potential to shorten procedure times and minimize complications plus dramatically add to the total number of procedures being performed -- enabling patients with CTOs to be treated in the cath lab rather than in the surgery suite. At the estimated procedure volume of over 200,000 cases per year -- and factoring in the potential for market expansion -- the total market potential for Novelis' CTO products is estimated at over $500 million," he added.

    Re CTOs, current angiographic tools are simply inadequate to guide CTO crossing. Novelis is a first forward-looking technology with a strong likelihood of providing a viable solution for guiding CTO recanalization.

    "Catheter-based treatment of chronic coronary total occlusion is one of the remaining major clinical challenges in interventional cardiology," commented Dr. David Williams, MD, Professor of Medicine and Director of the Cardiac Catheterization Laboratory and Interventional Cardiology at Rhode Island Hospital and advisor to Novelis. "Currently, the lack of safe and predictable treatment modalities results in most CTO patients being referred to open-heart bypass surgery. I have performed pre-clinical work with the Novelis device which, in my view, demonstrated clear differentiation of coronary anatomy and sufficient ablative power necessary to guide the Interventional Cardiologist safely through a CTO."
    Despite the fact that the aorta poses as a large-diameter, receptive lumen for a subintimal attempt at recanalization, the reality is that a hydrophilic wire will frequently stay subintimal with a retrograde approach. This situation produces an uncomfortable circumstance wherein one is tempted to keep pushing a plane of dissection into the aorta in hopes of eventually re-entering the true lumen. IVUS can visualize the target lumen and to direct a nitinol, hypotube needle safely into the true lumen of the aorta, without needless lengthy dissection planes. Increasing evidence indicates that true lumen re-entry in the aortoiliac region should be performed with an IVUS-based device because errant needle punctures may have profound consequences, such as retroperitoneal bleeding. One should have immediate access to a covered stent prior to initiating a procedure involving an occluded intrapelvic artery. Accurate re-entry utilizes a real-time IVUS image of the target lumen.

    VOLC IVUS/FM platforms for with more than 3300 installed systems continue to gain market share with the leading cath lab equipment manufactures. Our new Philips partner for resale of Volcano branded s5i IVUS systems & Allura Xper FD X-ray will be additive.
    Combined IVUS/FM markets = $420M growing +15%/year.

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    • R&D = [1] combining IVUS & bare metal stents and a balloon on a single catheter; and [2] vulnerable plaque, Inter Cardiac Echo are forward looking IVUS.
      We have joint deals with all the major cath lab equipment manufactures. W/ >6000 cath labs in the US, Japan and Europe and the penetration of integrated IVUS systems is under 500 or less than 10% of these facilities. Both Boston [our only significant competitor] and Volcano believe that IVUS can achieve a 90% penetration of this market over the next five years. Our stated goal is to get 70% of this market. In addition we are launching new wires and other enhancements to this offering in Q2 this year at the PCR.
      There are many ongoing cardiovascular clinical trials where IVUS is used to evaluate effectiveness. We believe the potential market for using IVUS and OCT to reevaluate plaques for local or systemic therapy is about 6 million diagnostic angiography and PCI procedures annually.

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