| Commercial Approval: |
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Received FDA approval in March 2004 based on results from the TAXUS IV Clinical Trial.
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The TAXUS Express2 stent system was awarded a CE Mark on January 21, 2003.
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| Development Status - Commercial Events: |
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Boston Scientific legal victories related to the Cook-Guidant relationship and its licensing agreement with Angiotech for paclitaxel have currently blocked Guidant from the paclitaxel-eluting stent market and the general drug-eluting stent market for at least 2 years. (January 2003)
Boston Scientific and Cordis/J&J continue to battle over patent infringement lawsuits. (January 2003) |
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The partnership between Boston Scientific and Medinol ended with lawsuits files on both sides. Medinol claims that Boston Scientific set up a secret operation to develop a stent that infringes on patents related to its NIR stent. Boston Scientific claims that it did so legally and in accordance with its agreement with Medinol. A federal court ordered to trial Medinol's claims against Boston Scientific in December 2004.
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| Development Status - Clinical Trials: |
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Phase II |
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TAXUS IV is a 2000-patient clinical trial with four treatment groups. TAXUS IV will compare the paclitaxel-coated Express stent to bare stents in de novo lesions. In addition, the trial will evaluate the effectiveness of the paclitaxel-coated Express stent to brachytherapy in patients with in-stent restenosis. 2017 However, FDA regulators did not approve the initial TAXUS IV IDE application. Boston Scientific will re-file. |
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The TAXUS IV-SR trial randomized 1,314 patients to the Taxus stent or an Express bare metal stent control to demonstrate superior 1-year outcomes for the Taxus stent in patients with de novo, native coronary lesions (≤28mm in length, RVD 2.5 - 3.75 mm).
Results: The following are 1-year follow-up results. TLR was necessary in 4.4% of Taxus patients vs. 15.1% of control patients (p<0.0001). TVR was necessary in 7.1% of Taxus patients vs. 17.1% of control patients (p<0.0001). TVF occurred in 10.0% of Taxus patients vs. 19.4% of control patients (p<0.0001). MACE was 10.8% in the Taxus group vs. 20.0% in the control group (p<0.0001). MI occurred in 3.5% of Taxus patients vs. 4.7% of control patients (p=0.31). Stent thrombosis occurred in 0.6% of Taxus patients vs. 0.8% of control patients (p=0.72). (April 2004)
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The following are 2-year follow-up results for the TAXUS IV trial. MACE occurred in 14.7% of Taxus patients vs. 24.9% of control patients (p<0.0001). TVR was necessary in 10.6% of Taxus patients vs. 21.1% of control patients (p<0.0001). TLR was necessary in 5.6% of Taxus patients vs. 17.4% of control patients (p<0.0001). TVF occurred in 14.0% of Taxus patients vs. 24% of control patients (p<0.0001). (2004) |
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The TAXUS V clinical trial addressing long lesions and small vessels evaluated the slow-release Taxus stent in 1,108 patients with de novo lesions (10 - 46 mm in length) who were randomized to either the Taxus stent or an Express control stent.
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The TAXUS V clinical trial addressing ISR randomized 488 patients to the slow-release Taxus stent or beta-source brachytherapy to compare 9-month TVR rates (patients with ISR, lesion length <46 mm). |
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The TAXUS VI clinical trial randomized 448 patients to the moderate-release Taxus stent or to a bare Express stent to evaluate rates of TVR in patients with complex lesions.
Results: The 9-month rate of binary restenosis was 9.1% in the Taxus group vs. 32.9% in the control group. LLL was 0.39 mm in the Taxus group vs. 0.99 mm in the control group. The overall rate of MACE at 9 months was 16.4% in the Taxus group vs. 22.5% in the control group (p=0.12). TLR at 9 months was necessary in 6.8% of Taxus patients vs. 18.9% of control patients (p=0.0001). TVR at 9 months was 9.1% in the Taxus group vs. 19.4% in the control group (p=0.0027). The rate of TVF at 9 months in the Taxus group was 16.0% vs. 22.0% in the control group (p=0.12). The rate of stent thrombosis at 9 months was 0.5% in the Taxus group vs. 1.3% in the control group (p=0.62). (2004)
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The ERACI III trial will compare the Cypher and Taxus Express DES vs. historical bare stent and CABG data in 225 randomized patients with de novo lesions.
Results are pending as of 2004. |
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