Navigation Links
Abbott Announces Positive Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold Technology
Date:3/15/2010

ATLANTA, March 15 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) and a very low rate of major adverse cardiac events (MACE(1) rate of 2.0 percent) at 30 days. These results build on the long-term success Abbott has seen with the BVS technology in the first phase of the ABSORB trial, which has generated positive data on 30 patients out to three years. Data from the second phase of the trial was presented at the American College of Cardiology's 59th annual scientific session in Atlanta.

"The positive 30-day results reaffirm my belief that a device that bioresorbs, or disappears, into the body after restoring blood flow is the next logical step in the treatment of cardiovascular disease," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. "The continuing positive results of the ABSORB trial and the clinical benefits demonstrated to date by Abbott's bioresorbable technology show promise that a bioresorbable scaffold is on its way to becoming a clinical reality and will be the next revolution in interventional cardiology."

This second phase of the ABSORB clinical trial (Cohort B) enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support. Abbott is the only company with long-term, three-year clinical data on a complete patient set evaluating the safety and performance of a fully bioresorbable drug eluting scaffold.

"The encouraging 30-day results show that Abbott's BVS is able to restore blood flow with no cases of blood clots or repeat procedure, suggesting that there could be important clinical benefits for patients," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "If Abbott's bioresorbable technology continues to perform well in clinical trials, it has the potential to become the new standard of care for patients with coronary artery disease."

Abbott's investigational BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to ultimately move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration therapy, is what makes Abbott's BVS unique in the field of cardiology.  

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated site thrombosis rates – at 30 days; six, nine, 12, 18 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months.

Abbott's bioresorbable technology delivers everolimus, a drug that inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 83,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

(1) MACE is a composite measure of key efficacy and safety endpoints and includes cardiac death,

heart attack (myocardial infarction) and ischemia-driven target lesion revascularization.

SOURCE Abbott

Back to top

RELATED LINKS
http://www.abbott.com

'/>"/>

SOURCE Abbott
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
2. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
3. Abbott Initiates Clinical Study to Evaluate Use of RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Renal Artery Stenosis
4. Abbotts ABT-874 Shows Positive Results for Maintenance of Response in Phase II Psoriasis Study
5. Abbotts XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
6. Abbott Announces Positive One-Year Results from the Worlds First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
7. Abbotts m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
8. Abbotts HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
9. Abbotts XIENCE(TM) V Drug Eluting Stent Demonstrates Consistent and Positive Clinical Outcomes Out to Two Years
10. Abbotts Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
11. Study in JAMA Shows Patients Treated With Abbotts XIENCE(TM) V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing ... their videos a whole new perspective by using the title layers in ProSlice ... , ProSlice Levels contains over 30 Different presets to choose from. FCPX ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
(Date:6/25/2016)... ... ... The temporary closing of Bruton Memorial Library on June 21 due to a possible lice ... overlooked aspect of head lice: the parasite’s ability to live away from a human host, ... a necessary one in the event that lice have simply gotten out of control. , ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/25/2016)... Canada (PRWEB) , ... June 25, 2016 , ... Conventional ... pursuit of success. In terms of the latter, setting the bar too high can ... risk more than just slow progress toward their goal. , Research from ...
Breaking Medicine News(10 mins):