Why the study?
Does the SilverHawk System effectively excise plaque and improve minimal luminal diameter in complex coronary lesions?
Does the SilverHawk System effectively excise plaque and improve minimal luminal diameter in complex coronary lesions?
The SilverHawk System demonstrates early feasibility and efficacy in plaque excision and improving luminal diameter in both porcine models and human complex coronary lesions.
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Supports feasibility of plaque excision in complex lesions; leaves open efficacy and safety versus prior DCA in trials.
The use of directional coronary atherectomy (DCA) in current practice has been limited. The SilverHawk System is a newly developed plaque excision device that aims to overcome the drawbacks of prior DCA platforms. The device was evaluated in a porcine coronary model and in a series of patients. Procedural variables along with outcomes were reviewed. Quantitative angiography (QCA) was performed and excised tissue fragments were weighed and examined histologically. In porcine cases, pretreatment MLD increased from 0.51 +/- 0.26 to 2.36 +/- 0.59 mm postdebulking and 19.9 +/- 7.6 mg of tissue was retrieved. In human cases, pretreatment MLD increased from 0.8 +/- 0.4 to 2.2 +/- 0.5 mm postdebulking and 15.2 +/- 7.8 mg of tissue was retrieved without complications. These data show that the SilverHawk System may offer significant utility in treating a wide variety of complex coronary lesions.
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Ikeno et al. (2003) studied this question.
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