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Product Name: XIENCETM V everolimus-eluting coronary artery stent system
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(Peripheral Vascular Therapeutics, Cardiovascular Therapeutics, Lower Limb Stenting and Advanced Arterial Therapeutics)
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P00389
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| Commercial Approval: |
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Received FDA approval on July 2, 2008 for the XIENCE™ V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease |
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| Development Status - Commercial Events: |
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Guidant began to investigate Everolimus following legal battles with Boston Scientific. The legal issues stemmed from a licensing agreement between Boston Scientific and Angiotech for paclitaxel. Legal issues also arose from the Guidant-Cook agreement in the DELIVER trial which tested the Achieve paclitaxel DES. (January 2003) |
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Johnson & Johnson will pay $23.9 Billion to purchase Guidant, pending regulatory and shareholder approval. The merger is expected to be complete in Q3 2005. J&J plans to retain Guidant's name and merge its Cardiovations and Cordis units into the new business unit. The Cordis name will reportedly remain associated with certain products. (December 2004)
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Abbott Vascular completed the acquisition of Guidant's vascular business in April 2006. The acquisition was made in connection with Boston Scientific's acquisition of Guidant Corporation.
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XIENCE V will be launched in the United States immediately. (July 2008)
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| Development Status - Clinical Trials: |
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The Vision-E trial was renamed the SPIRIT FIRST dose-selection clinical trial. 60 patients with de novo lesions (≤12mm, RVD 2.8mm - 3.2mm) were randomized to the Vision DES or a control stent to evaluate the safety and efficacy of the Vision DES.
Results: In-stent LLL at 6 months was 0.10 mm in the DES group vs. 0.84 mm in the control group (p<0.0001). In-stent binary restenosis was 0% in the DES group vs. 26.9% in the control group (p=0.01). MACE at 6 months was 7.7% in the DES group vs. 21.4% in the control group. MACE did not change between 30 days and 6 months in the DES group. At 6 months, TLR was necessary in 3.8% of DES patients vs. 21.5% of control patients. The MLD at 6 months in the DES group was 2.28mm vs. 1.58mm (p<0.0001). The %DS in the DES group was 16 vs. 39 in the control group (p<0.0001). (September 2004)
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The SPIRIT II trial is planned to commence in Q1 2005. |
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The 1,000-patient SPIRIT III U.S. pivotal trial is planned to commence in Q1 2005. In-segment LLL at 9 months will be the primary endpoint. |
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Abbott presented data in May 2008 stating that the SPIRIT III trial, 1,002 patient pivotal clincal trial, had the following results: A 45 percent reduction in the risk of major adverse cardiac events (MACE) compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004); A 32 percent reduction in the risk of TVF compared to TAXUS (10.7 percent for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04); Low rates of stent thrombosis between one and two years, defined as very late stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS) and per the SPIRIT III protocol (0.2 percent for XIENCE V and 1.0 percent for TAXUS) |
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| Comments: |
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In an October 2005 press release, Guidant announced that it has successfully concluded an inspection of its manufacturing and quality systems and is currently waiting for a review of its submission for a CE Mark to commercialize the XIENCE V stent in Europe.
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Guidant plans to launch the Multi-Link Vision-E stent prior to the Champion stent due to manufacturing issues. (October 2004) |
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The Vision-E stent is expected to launch in Europe in the first half of 2006 and in the U.S. by 2007. (October 2004) |
Last Update: March 2, 2009 |
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