Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

BIOTRONIK Announces 12-Month Results from 4EVER Study

Published: Monday, November 19, 2012
Last Updated: Monday, November 19, 2012
Bookmark and Share
Results show strong evidence of benefits for lower limb intervention when using Pulsar stents.

BIOTRONIK has announced the twelve-month results from the prospective, multicenter, single-arm 4EVER study, which demonstrates the efficacy and safety of BIOTRONIK’s Pulsar self-expanding stent system in 120 superficial femoral artery (SFA) patients.

Twelve-month data for the full cohort showed an impressive 81.4% primary patency rate and a freedom from TLR (target lesion revascularization) rate of 89.3%.

The Pulsar-18 subgroup, which had an average lesion length of 10.5 cm, showed a primary patency rate of 73.4% and freedom from TLR rate of 85.2%.

Dr. Marc Bosiers, Chief of Surgery at AZ Sint-Blasius in Dendermonde, Belgium, initiated the study, which investigated both the acute and long-term performance of 4F-compatible devices.

The study examined the efficacy of Pulsar stents and the feasibility of treating patients with 4F devices from BIOTRONIK, including the Fortress 4F sheath, Passeo-18 balloon, and Astron Pulsar and Pulsar-18 stents.

“These results are certainly in line with published studies of similar lesion lengths using thick strut, high radial force stents,” said Dr. Koen Deloose, AZ Sint-Blasius in Dendermonde, Belgium.

Deloose continued, “We generally find that the vast majority of lesions can be treated with Pulsar stents. The fact that the 4EVER study showed 100% technical success in a population where 31% of lesions were calcified-with patency rates and freedom from TLR rates similar to high radial force stents-seems to support this. In fact, analysis of calcified vs. non-calcified lesions showed patency rates of 80.2% and 82.0% respectively with no statistical significant difference. In addition, no clinical data is available that proves whether any currently available self-expanding stent can successfully treat heavily calcified ‘coral reef’ lesions.”

Pulsar stents feature an innovative, highly flexible design coated with PROBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility-which is believed to contribute to the stent’s excellent clinical results.

Pulsar-18 is available in diameters from 4–7 mm and lengths from 20–200 mm and deliverable through a 4F sheath. The recently launched Pulsar-35 stent uses the exact same stent technology for use on a 0.035"/6F delivery system.

“The 4EVER results strongly suggest that Pulsar stent systems with optimal radial force combined with high flexibility are superior to systems which concentrate mainly on high radial force in treating SFA disease,” explained Alain Aimonetti, Vice President Sales and Business Development, BIOTRONIK Vascular Intervention.

Aimonetti continued, “Our expectations are for an even greater differential in clinical outcomes when the 24-month data are presented. We have invested heavily in clinical studies aimed at providing data to further support Pulsar stents in a variety of clinical settings.”

Further Information

Join For Free

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 3,500+ scientific posters on ePosters
  • More than 5,200+ 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 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

BIOTRONIK Orsiro Hybrid DES Lives Up to Abbott’s XIENCE PRIME™
Positive 9 month results from BIOFLOW-II clinical trial and 12 month results from BIOFLOW-III registry presented at EuroPCR congress.
Tuesday, July 09, 2013
BIOTRONIK Home Monitoring® Reduces Inappropriate ICD Shocks by 52%
ECOST trial results published in European Heart Journal.
Friday, December 21, 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
Salford Lung Study - The First Real World Clinical Trial
In this podcast, we learn about the Salford Lung Study and its potential to revolutionize the way we assess new drugs and treatments around the world.
Anti-Inflammatory Drugs Could Help Treat Depression
Anti-inflammatory drugs could be used to treat some cases of depression, which further implicates our immune system in mental health disorders.
NIH Contributes to Global Effort to Prevent and Manage Lung Diseases
The large scale trial will measure health benefits of clean cookstoves.
Questioning the Safety of Selenium to Combat Cancer
Research indicates the need for change in practice as selenium supplements cannot be recommended for preventing colorectal cancer.
Scientists at NIH and Emory Achieve Sustained SIV Remission in Monkeys
The finding suggest that the immune systems of these animals are controlling SIV replication in the absence of antiretroviral therapy.
Painting the Way to Tumour Imaging
Tumour paint used in emergency surgery to aid cell identification for surgeons.
Anti-Cancer Drug Uses Tumour mRNA to Identify Responders
Phase I study of novel anti-cancer drug uses tumour mRNA expression to identify patients who will respond to the drug.
Targeting Estrogen Receptor Improves Survival in Breast Cancer
Trial finds estrogen receptor degrader significantly increases progression-free survival in patients with advanced breast cancer.
Clinical Trial Finds Medicine Program Alters Blood Serum
Meditation, yoga and vegetarian diet linked to decline in plasma metabolites associated with inflammation and cardiovascular disease risk.
Alzheimer’s Linked Protein Can Be Removed From Brain Without Hindering Memory, Learning
Researchers at UTSW have found that the mice can maintain their learning and memory when virtually all ApoE is removed from the brain but kept present in the liver to filter cholesterol.
Scroll Up
Scroll Down

SELECTBIO Market Reports
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,200+ scientific videos