BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

BIOTRONIK Pulsar Stent Delivers Excellent Primary Patency and Freedom From TLR Rates in 12-Month 4EVER Study Results


11/15/2012 11:53:08 AM

BUELACH, Switzerland, November 15, 2012—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. “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. “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.”

Contact:

Manuela Schildwächter

Communications & PR Manager

BIOTRONIK SE & Co. KG

Woermannkehre 1

12359 Berlin

Tel. 49 (0) 30 68905 1466

Email: manuela.schidwaechter@biotronik.com

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of more than 5,600 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success—and deliver confidence and peace of mind to physicians and their patients worldwide.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES