Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BIOTRONIK Orsiro Hybrid DES Lives Up to Abbott’s XIENCE PRIME™

Published: Tuesday, July 09, 2013
Last Updated: Tuesday, July 09, 2013
Bookmark and Share
Positive 9 month results from BIOFLOW-II clinical trial and 12 month results from BIOFLOW-III registry presented at EuroPCR congress.

Primary end-point results from the BIOFLOW-II Clinical Study demonstrating the non-inferiority of the BIOTRONIK Orsiro Hybrid Drug-Eluting Stent compared to Abbott's XIENCE PRIME™.

These results were presented in a late-breaking clinical trials session at the EuroPCR congress in Paris by principal investigator, Prof. Stephan Windecker, MD of University Hospital Bern, Switzerland.

BIOFLOW-II is a prospective, international, multi-center, randomized trial evaluating the safety and efficacy of Orsiro against XIENCE PRIME™.

The primary endpoint is in-stent late lumen loss at nine months. Secondary clinical endpoints include Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Grafting (CABG) and clinically driven Target Lesion Revascularization (TLR).

In addition to angiographic follow-up, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging were performed at nine months. Clinical follow-up took place at one, six and nine months and will continue annually for up to five years.

Between July 2011 and March 2012, 452 patients were enrolled in a 2:1 (Orsiro:XIENCE PRIME™) randomization at 24 European sites.

At nine months, the results for the primary endpoint in-stent late lumen loss were 0.10 ±0.32 mm in the Orsiro arm and 0.11 ±0.29 mm in the XIENCE PRIME™ arm evaluated by an independent core laboratory and confirming the non-inferiority hypothesis.

“The Orsiro stent met the primary non-inferiority endpoint of late loss at 9 months compared to the XIENCE PRIME™ stent, demonstrating effectiveness of drug elution from this bioabsorbable polymer,” commented Prof. Windecker.

Prof. Windecker continued, “The platform also appears to be safe, with low rates of myocardial infarction and revascularization and no reported stent thrombosis. The low strut thickness and good deliverability of Orsiro is advantageous during complex stenting which is performed in current cath lab practice.”

The primary end-point results from the BIOFLOW-III registry were also presented at the EuroPCR congress in Paris by coordinating investigator Prof. Johannes Waltenberger, MD of Universitätsklinikum Münster, Germany, further demonstrating the clinical benefits of Orsiro.

BIOFLOW-III is an international, prospective, non-randomized, multi-center, open-label clinical evaluation of the Orsiro Hybrid Drug-Eluting Stent.

The primary endpoint is Target Lesion Failure (TLF) at 12 months defined as a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction (MI), emergent Coronary Artery Bypass Graft (CABG), and clinically driven Target Lesion Revascularization (TLR).

Pre-specified sub-groups include diabetes, small vessels (≤2.75 mm), chronic total occlusion (CTO) and Acute Myocardial Infarction (AMI).

Between August 2011 and March 2012, 1,356 patients were enrolled at 43 sites in 14 countries. At 12 months, the result for the primary endpoint TLF is 4.7%.

With a breakdown into cardiac death 1.3%, target vessel MI 2.0%, emergent CABG 0.0% and clinically driven TLR 2.7%.

“The results from this large all comers registry confirms the efficacy and safety of Orsiro in a large and more complex patient population,” commented Prof. Waltenberger.

The Orsiro Hybrid Drug-Eluting Stent (DES), launched in 2011, features the latest development in BIOTRONIK stent technology-a unique hybrid solution that combines passive and active components.

PROBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bio-absorbable matrix. This hybrid coating is layered on top of the high performance PRO-Kinetic Energy stent platform, renowned for its advanced thin-strut stent design and outstanding deliverability.

“BIOTRONIK already offers a strong coronary and peripheral passive device portfolio, and we will continue to introduce innovative technologies,” commented Alain Aimonetti, Vice President Sales and Business Development, BIOTRONIK Vascular Intervention.

Aimonetti continued, “The exciting addition of the Orsiro Hybrid DES allows us to offer the world’s most advanced product portfolio for vascular intervention and paves the way for the drug-eluting absorbable scaffold we are developing.”


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More Than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

FDA Approves First Single-Lead ICD with Atrial Sensing
BIOTRONIK’s Lumax DX system could help the 50,000 patients each year who may benefit from atrial sensing, without pacing indication.
Tuesday, September 17, 2013
BIOTRONIK Home Monitoring® Reduces Inappropriate ICD Shocks by 52%
ECOST trial results published in European Heart Journal.
Friday, December 21, 2012
BIOTRONIK Announces 12-Month Results from 4EVER Study
Results show strong evidence of benefits for lower limb intervention when using Pulsar stents.
Monday, November 19, 2012
First CRT-D Patient Enrolled in the EuroEco ICD/CRT-D Trial
Study to assess the economic effects of BIOTRONIK Home Monitoring®.
Tuesday, July 24, 2012
Large-Scale BIOTRONIK SPIRIT-ICD Study Enrollment Complete
SPIRIT-ICD study explores benefits of intensified diagnostic follow-up and timely therapeutic intervention for high-risk patient group.
Monday, July 09, 2012
Scientific News
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
LaVision BioTec Reports on the Neuro Research on the Human Brain After Trauma
Company reports on the work of Dr Ali Ertürk from the Institute for Stroke and Dementia Research at LMU Munich.
NIH Study Shows No Benefit of Omega-3 Supplements for Cognitive Decline
Research was published in the Journal of the American Medical Association.
Less May Be More in Slowing Cholera Epidemics
Mathematical model shows more cases may be prevented and more lives saved when using one dose of cholera vaccine instead of recommended two doses.
Investigating the Vape
Expert independent review concludes that e-cigarettes have potential to help smokers quit.
NIH Launches Human RSV Study
Study aims to understand infection in healthy adults to aid development of RSV medicines, vaccines.
Researchers Discover Synthesis of a New Nanomaterial
Interdisciplinary team creates biocomposite for first time using physiological conditions.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
Flu Remedies Help Combat E. coli Bacteria
Physiologists from the University of Zurich have now discovered why the intestinal bacterium Escherichia coli (E. coli) multiplies heavily and has an inflammatory effect.
Marijuana Genome Unraveled
A study by Canadian researchers is providing a clearer picture of the evolutionary history and genetic organization of cannabis, a step that could have agricultural, medical and legal implications for this valuable crop.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!