Cardiovascular Business - September/October 2008 - (Page 11) n Salmon Endeavor zotarolimus-eluting stent Medtronic Sean Salmon, general manager at Medtronic (Endeavor) both in terms of thrombosis and to lessen the rates of thrombosis to levels lower than even for BMS. It’s a two-step process. The first step is to introduce a bioabsorbable polymer, which allows the effect of the drug in reducing restenosis, while the polymer goes away. The next step is to add active anti-thrombotic activity to the device in addition to sirolimus to prevent restenosis. l Simonton: Abbott has already made an impact on patient safety with the XIENCE V platform, which is trending very strongly in terms of reducing death and MI compared to first-generation DES. A stent thrombosis rate of 0.2 percent to 0.3 percent, such as with the XIENCE V, may be difficult to improve upon, unless it’s with a stent that goes away completely. About two years after treatment with a bioabsorbable stent, the vessel can get larger; it can actually respond more normally as most vessels do to vaso-reactants and be more like a normal vessel. So, Abbott’s strategy is to have a safe non-inf lammatory fully biodegradable polymer-based stent that will lead the vessel back into its native state, allowing it to accommodate future changes similar to the way a previously untreated vessel might do. are unchanged from the three-year mark and very close to the two-year mark. s Rogers: Traditionally, in the BMS era there was a tremendous focus on the speed with which a device could be introduced, so-called deliverability, with very similar outcomes across BMS. Now, as we see differences emerging in the long-term performance of DES and superiority of some DES over others, it’s that long-term benefit that ought to drive the choices of practitioners and administrators. That’s certainly where our focus on differentiation would be. l Simonton: The XIENCE V stent from Abbott Vascular is the first DES to show superiority over another DES in two randomized clinical trials. What matters to patients are the clinical outcomes, such as major adverse cardiac events. The data from the SPIRIT III trial show our low event rate with XIENCE V is holding up and even becoming numerically wider at two years with stent thrombosis rates, lower than TAXUS, the current market leader. During the next year, we’ll have over 14,000 patients internationally in trials looking at these types of safety issues. The position of Abbott Vascular with XIENCE V is clinical superiority over the first-generation DES, based on available data from two randomized clinical trials, and we are going to continue to innovate on that. u Dawkins: In the U.K, where I come from, there are 22 different DES with CE mark. So the decision for physicians becomes more complicated. The rationale for choosing one over another can be channeled into a number of areas. Physicians will look at the patient outcomes data. They also will be interested in the handling characteristics of the stents, the effectiveness of the drug and the cost of the stent. Boston Scientific is in the unique position of having two DES products, the PROMUS and the TAXUS stents, which have two platforms, two different drugs, two different delivery systems and two different polymers. We would hope that interventional cardiologists will appreciate different products and choose appropriately. : Because DES choices in the U.S. have doubled over the past year, how do you intend to differentiate or market your product? n Salmon: We are sticking with what the evidence says about our device. There has been a lot of focus in the marketing of these devices on surrogate markers and angiographic markers. Our focus has been on the clinical benefit gained by a patient who has a procedure. We have proven in our evidence that our DES is superior clinically to a BMS and that we are not inferior to two of the present devices in terms of clinical events. Ease of use, of course, is an easy marketing focus, but it’s the quality of the long-term data that we have got, with an excellent safety record and an interesting and perhaps differentiating emergence of a stable clinical result for target lesion revascularization rates out for four years that CardiovascularBusiness.com Cardiovascular Business 11 http://CardiovascularBusiness.com
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