Navigation Links
FDA Advisory Committee Recommends Approval of Abbott's XIENCE(TM) V Drug Eluting Stent System
Date:11/29/2007

ABBOTT PARK, Ill., Nov. 29 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT)announced today that the Circulatory System Devices Advisory Panel to the U.S. Food and Drug Administration (FDA) recommended approval for the XIENCE(TM) V Everolimus Eluting Coronary Stent System. XIENCE V is a next-generation drug eluting stent intended for use in the treatment of coronary artery disease.

The FDA advisory committee voted to recommend the XIENCE V stent system for approval with conditions related to post-marketing study requirements and language related to dual antiplatelet therapy. The FDA is not required to, but usually follows the recommendations of its advisory committees.

"The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the U.S. have been consistent and significant across the SPIRIT trials," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York and principal investigator of the SPIRIT III clinical trial. "The robust body of safety and efficacy data support approval of XIENCE V as an important new technology that will enhance the lives of millions of patients with heart disease."

Abbott filed its Premarket Approval (PMA) submission for XIENCE V with the FDA on June 1, 2007. The PMA for XIENCE V is the first to include data demonstrating superiority of one drug eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product.

"The outcome of today's advisory committee meeting is very encouraging," said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. "We look forward to bringing this important new treatment for coronary artery disease to physicians and patients in the U.S."

XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational
'/>"/>

SOURCE Abbott
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Genaera Announces Formation of Scientific Advisory Board for Obesity Drug Candidate Trodusquemine (MSI-1436)
2. China Holdings Appoints Ronald Shon Chairman of Advisory Board to Its Wholly-Owned Subsidiary China Power, Inc.
3. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
4. Patient Safety Authority Board of Directors Names Infection Advisory Panel
5. Broker a Suite of Research & Advisory Services to Enhance Human Resources
6. Lynn Clark Callister, National Leader in Maternal-Child Health Nursing, Joins March of Dimes Advisory Council
7. MaxLife Fund Corp. appoints Daniel E. Kahan, to its Advisory Board
8. Delta Dental Plans Association Forms National Scientific Advisory Committee
9. Alter+Care Creates the Advisory Board
10. Patient Safety Authority Releases Advisory Focusing on Common Causes of Medication Errors
11. Susan G. Komen for the Cure Appoints Dr. Amelie G. Ramirez to Scientific Advisory Board
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... The federal court overseeing thousands of vaginal mesh ... District of West Virginia has upheld a $2 million verdict ... trial. In an Order dated January 21st, the Court denied ... C.R. Bard had not proven a miscarriage of justice. (Cisson ...
(Date:1/22/2015)... For over 20 years, Dr. David Cruz of ... area has treated just about every type of injury that ... And for those same twenty-plus years, the team at Doctors ... with the best possible doctor. With the combined breadth ...
(Date:1/22/2015)... has added many trendy Champagne wedding dresses to ... the past three years. Today, the business announces a special ... the sales manager of the company, this is on the ... point can be reflected on the discounted wedding dresses from ...
(Date:1/22/2015)... 2015 As interest in the value of ... momentum worldwide, Rev. Eric J. Hall , president and ... (HCCN), will be the keynote speaker on January 27 at ... health system. , The conference, “Hope and Resilience: Innovative and ...
(Date:1/22/2015)... 22, 2015 State Forestry Institute of ... system with support from GEOSYSTEMS, a dedicated Hexagon Geospatial ... will leverage Hexagon Geospatial’s ERDAS APOLLO for ... well as point clouds and documents. This effort will ...
Breaking Medicine News(10 mins):Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:State Forestry Institute Mecklenburg-Vorpommern, Germany Embraces Hexagon Geospatial Technology 2Health News:State Forestry Institute Mecklenburg-Vorpommern, Germany Embraces Hexagon Geospatial Technology 3
... LA CROSSE, Wis., April 21 When Gundersen Lutheran Health ... for the 1 to 2 percent decrease that,s common at ... more reduction in less than two years. That,s 9,600 metric ... the environment, the equivalent of removing 1,631 cars from the ...
... NeoGenomics, Inc. (NASD OTC BB: NGNM) ... quarter 2009 financial results on Thursday, April 23, 2009.The Company ... Q1 2009 results on April 23, 2009, at 11:00 AM ... (201) 689-8049 (international) at least five minutes prior to the ...
... Exposition Park LOS ANGELES, ... Dimes premier fundraising event that benefits all babies--those born healthy ... walkers are expected at this largest March for Babies event ... at the corner of S. Figueroa and 39th St., Los ...
... Features Gold Glove Outfielder Nate McLouth, Three Teen ... in partnership with the Pittsburgh Pirates baseball club ... the launch of a new campaign designed to ... infection MRSA and how regular hand-washing can help ...
... Seven years after becoming the Midwest,s first graduate school ... Chicago School of Professional Psychology is expanding its forensic ... to advance their career in the law and legal sectors. ... this fall at the school,s Chicago Campus at 325 N. ...
... had reduced risk of relapse or death, study finds ... non-Hodgkin lymphoma who drank wine before their diagnosis appeared ... according to a study that,s the first to identify ... 500 women with non-Hodgkin lymphoma and found that, overall, ...
Cached Medicine News:Health News:Innovative Program Will Help Lead Health System to Energy Independence by 2014 2Health News:NeoGenomics Schedules its Q1 2009 Earnings Release for April 23, 2009 2Health News:NeoGenomics Schedules its Q1 2009 Earnings Release for April 23, 2009 3Health News:Farmers Insurance Joins March of Dimes March for Babies April 25, 2009 2Health News:Pittsburgh Hospital Teams with Pirates Baseball Club in Unique Effort to Encourage Teen Handwashing, Prevent Spread of MRSA 2Health News:Pittsburgh Hospital Teams with Pirates Baseball Club in Unique Effort to Encourage Teen Handwashing, Prevent Spread of MRSA 3Health News:The Chicago School of Professional Psychology Announces Nation's First Psy.D. Program in Clinical Forensic Psychology 2Health News:The Chicago School of Professional Psychology Announces Nation's First Psy.D. Program in Clinical Forensic Psychology 3Health News:Wine May Guard Against Lymphoma Recurrence 2
(Date:1/23/2015)... , Jan. 23, 2015  Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT), ... I trial of Lixte,s lead compound, LB‑100, is being conducted, ... John S. Kovach , M.D., the founder and President ... be completed at a single site. Accrual of patients, however, ...
(Date:1/23/2015)... Gem Pharmaceuticals announced today that the initial soft tissue ... Phase 2 clinical trial.  This open-label study will assess ... (an investigational medication), in approximately 30 adults as first-line ... Logo - http://photos.prnewswire.com/prnh/20150123/170966LOGO GPX-150 is ...
(Date:1/22/2015)... Jan. 22, 2015  Uroplasty, Inc. (NASDAQ: UPI ), ... innovative proprietary products to treat voiding dysfunctions, today reported ... 31, 2014.  Global revenue for the Company,s ... million, a new quarterly revenue record, as compared to ...
Breaking Medicine Technology:Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18
... Va., June 20, 2007 /PRNewswire/ -- ... the successful completion of,pharmacokinetic and pharmacodynamic ... long-acting interferon beta and,long-acting erythropoietin. , ... superb durability of the long-acting,proteins, indicating ...
... MONTREAL, June 19 /CNW/ - ConjuChem Biotechnologies (TSX:CJB),today ... Albumin Conjugate for the treatment of,Type 2 ... Scientific,Sessions of the American Diabetes Association (ADA) to ... The ADA's annual,Scientific Sessions meeting is one ...
Cached Medicine Technology:Modigene Announces Successful Completion of Pharmacokinetic &,Pharmacodynamic Pre-Clinical Experiments for Proprietary,Long-Acting Human Growth Hormone, Long-acting Interferon Beta and,Long-acting Erythropoietin 2Modigene Announces Successful Completion of Pharmacokinetic &,Pharmacodynamic Pre-Clinical Experiments for Proprietary,Long-Acting Human Growth Hormone, Long-acting Interferon Beta and,Long-acting Erythropoietin 3Modigene Announces Successful Completion of Pharmacokinetic &,Pharmacodynamic Pre-Clinical Experiments for Proprietary,Long-Acting Human Growth Hormone, Long-acting Interferon Beta and,Long-acting Erythropoietin 4ConjuChem Biotechnologies Reports PC-DAC:Exendin-4 Albumin,Conjugate Data Presented at American Diabetes Association Annual,Meeting 2ConjuChem Biotechnologies Reports PC-DAC:Exendin-4 Albumin,Conjugate Data Presented at American Diabetes Association Annual,Meeting 3
A conservative, cost effective alternative to total knee replacement for patients with osteoarthritis primarily confined to one compartment....
...
... The Maxim Knee employs titanium alloy ... an excellent fixation surface. Biomet's ArCom ... durable and proven bearing material. The ... full inter-changeability. Modular tibial components offer ...
... The Natural-Knee family is a ... with over 14 years of proven ... several innovative features including a proprietary ... fixation in active patients, a unique ...
Medicine Products: