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Product Name:   XIENCETM V Everolimus-Eluting Coronary Stent System

(Peripheral Vascular Therapeutics, Cardiovascular Therapeutics, Lower Limb Advanced Arterial Therapeutics)
P00389

Description:
   • 

A cobalt-chromium, rapid-exchange Multi-Link Vision stent coated with a durable polymer eluting the antiproliferative drug Everolimus
Company:
   •  Guidant Corporation (Abbott Vascular Devices)
   •  Novartis International AG
   •  Abbott Vascular Devices
Vessels:
   •  Lower Limb Arteries
   •  Popliteal Arteries
General Modality:
   •  Medical Devices
Specific Modality:
   • Stents
General Product Type:
   •  Drug-Eluting
Specific Product Type:
   •  Antiproliferative-eluting Stents
Clinical Trials:
   •  DESTINY - Drug Eluting Stents In The Critically Ischemic Lower Leg
   •  SPIRIT FIRST - A Clinical Evaluation of the Guidant MULTI-LINK VISION-E® RX Drug Eluting Stent System in the Treatment of Patients with De Novo Native Coronary Artery Lesions
   •  SPIRIT II - A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System in the Treatment of Patients with De Novo Native Coronary Artery Lesions
   •  SPIRIT III - A Clinical Evaluation of the XIENCE™ V Everolimus Eluting Coronary Stent System (CSS) in the Treatment of Subjects with De Novo Native Coronary Artery Lesions
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Product Image:
Commercial Approval:
   • Received FDA approval on July 2, 2008 for the XIENCE™ V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease
   •

CE Mark awarded in January of 2006 for Coronary use
   •

CE Mark awarded in November of 2009 to treat patients with diabetes
   •

Awarded CE Mark in Europe on May 15, 2012 for the use of dual anti-platelet therapy (DAPT) for at least three months after stent implantation in patients with coronary artery disease
Development Status - Commercial Events:
   • 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)
   • 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)
   •

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.
   •

XIENCE V will be launched in the United States immediately. (July 2008)
Development Status - Clinical Trials:
   •

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)
   • The SPIRIT II trial is planned to commence in Q1 2005.
   • 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.
   • 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)
Comments:
   •

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.
   • Guidant plans to launch the Multi-Link Vision-E stent prior to the Champion stent due to manufacturing issues. (October 2004)
   • 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)

Sources:

May 16, 2012 --- "Commercial Approval" field - Added CE Mark for May 15, 2012 --- "Sources" field - < http://www.abbott.com/news-media/press-releases/abbotts-xience-prime-and-xience-v-drug-eluting-stents-receive-indication-in-europe-for-minimum-th.htm > "Abbott's XIENCE PRIME™ and XIENCE V® Drug Eluting Stents Receive Indication in Europe for Minimum Three-Month Duration of Dual Anti-Platelet Therapy"; Abbott PR, May 15, 2012.

September 8, 2010 --- "Product Image" field - Added product image ---  "Sources" field - < http://www.ptca.org/news/2008/0702_XIENCEV.html > "Abbott's XIENCE V Everolimus Drug-Eluting Coronary Stent is Approved by FDA"; Stent News; July 2, 2008.

November 9, 2009 --- "Commercial Approval" field - Added CE Mark approval --- "Sources" field - < http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0793.htm > "Abbott's XIENCE PRIME™ and XIENCE V® Receive Indications in Europe for Treatment of Patients with Diabetes"; Abbott Vacular, November 2, 2009.

February 27, 2009 --- "Development Status - Clinical Trials" field - Added clinical trial data and link for DESTINY --- "Sources" field - < http://clinicaltrials.gov/ct2/show/NCT00510393 > "Drug Eluting Stents In The Critically Ischemic Lower Leg (DESTINY)"; Bosiers, M; Clinical Trials., August 1, 2007.

July 9, 2008 --- "Commercial Approval" field - Added FDA approval for the treatment of coronary artery disease  --- "Comments" field - Added August 2008 comment about launching the product in the US  --- "Sources" field - < http://www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0623.htm > "FDA Approves Abbott's XIENCE V™ Drug Eluting Stent"; Abbott Vascular, July 2, 2008.

July 3, 2008 --- "Development Status - Clinical Trials" field - Added clinical trial data and link for SPIRIT III --- "Sources" field - < http://clinicaltrials.gov/ct2/show/NCT00180479?term=spirit&rank=15 > "SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)"; Clinical Trials, July 3, 2008.

April 27, 2006 --- "Commercial Events" field - Added completion of purchase of Guidant  --- "Sources" field - < http://www.masshightech.com/stories/2006/04/17/daily35-Abbott-completes-Guidant-acquisition-Boston-Scientific-shares-rise.html > "Abbott completes Guidant acquisition; Boston Scientific shares rise"; Mass High Tech, April 21, 2006.

February 6, 2006 --- "Commercial Approval" field - Added CE Mark  --- "Sources" field - < http://www.ptca.org/pr_guidant/20060130.html > "Guidant Receives European Approval for XIENCE™ V Drug Eluting Coronary Stent"; Angioplasty.Org, January 30, 2006.

September 8, 2005 --- "Development Status - Clinical Trials" field - Added clinical trial data and link for SPIRIT FIRST --- "Sources" field - < http://clinicaltrials.gov/ct2/show/NCT00180453 > "SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System"; Clinical Trials, September 13, 2005.

September 17, 2005 --- "Development Status - Clinical Trials" field - Added clinical trial data and link for SPIRIT II --- "Sources" field - < http://clinicaltrials.gov/ct2/show/NCT00180310 > "SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System"; Clinical Trials, September 11, 2005.

December 15, 2004 --- "Commercial Events" field - Added purchase of Guidant --- "Sources" field - < http://bostonscientific.mediaroom.com/index.php?s=64&item=191 > "Johnson & Johnson and Guidant Announce Definitive Agreement Valued at $23.9 Billion Based on $76 per Share"; Boston Scientific, December 15, 2004.

October 2005 --- "Comments" field - Added October 2005 comment --- "Sources" field – Cannot find source for this comment. 

October 2004 --- "Comments" field - Added October 2004 comments --- "Sources" field – Cannot find source for these comments. 

January 29, 2003 --- "Commercial Events" field - Added XYZ event  --- "Sources" field - < http://www.theheart.org/article/262413.do > "Drug-eluting stents: Where they are now"; theheart.org, January 22, 2003.

Last Update: May 16, 2012

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