Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Extremely low 90-day cardiac device infection rates with TYRX antibacterial envelope use

13.05.2013
New prospective data presented on 1,000 patients at 2013 Heart Rhythm Society shows over 90 percent fewer major device infections

Use of TYRX, Inc.'s AIGISRx® Antibacterial Envelope reduced major infection rates by more than 90% in patients undergoing Cardiovascular Implantable Electronic Device (CIED) replacement procedures compared to similar high-risk cohorts, according to the CITADEL & CENTURION clinical study results presented on Saturday at the Late Breaking Clinical Trials session at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions.


AIGISRx® Antibacterial Envelope is indicated for holding a pacemaker or implantable cardioverter-defibrillator, thereby creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotics that elute (dissolve) within a 7 to 10 day period.

Credit: TYRX, Inc.

CITADEL / CENTURION is a prospective, multicenter clinical study to evaluate the major device infection and mechanical complication rates in the 12 months after implantation, in patients at high risk for CIED infection who have their CIED implanted with an AIGISRx Antibacterial Envelope. Study patients were enrolled at 55 US centers, and were at high-risk for infection because they were undergoing a CIED replacement procedure with an implantable cardioverter-defibrillator (ICD), (CITADEL), or a cardiac resynchronization therapy (CRT) device (CENTURION). The results from a planned interim analysis of the primary endpoints for the first 1000 eligible patients after 90 days of follow up were presented by Dr. Charles A. Henrikson, the Chief of Electrophysiology at the Oregon Health Sciences University.

Key study findings include:

The CITADEL / CENTURION cohort at 90 days of follow-up had 95% fewer major CIED infections than the pre-defined published control cohort of 533 ICD and CRT replacement procedures (Gould et al. JAMA 2006, 295(16); 1907-1911) which had a major CIED infection rate of 1.88% at a mean follow-up of 81 days (0.1% vs. 1.88%; P
The CITADEL / CENTURION cohort at 90 days of follow-up had 94% fewer major infections than the 45-day major infection rate of 1.7% reported for the cohort of 1081 ICD/CRT replacement procedures in the Ontario ICD Database (Krahn et al. Circulation Arrhythmia and Electrophysiology 2011 4(2) 136-42 (0.1% vs. 1.7%; P

There was 1 major infection (0.1%), the primary efficacy endpoint of the study, after 90 days of follow-up. There were 11 minor infections (limited to the incision and skin) (1.1%).

The incidence of the most common mechanical complication, major hematomas (1.5%), was not significantly different than the pre-defined control cohort (2.3%; P = NS).

There were no unanticipated serious AIGISRx-related adverse events. There were 20 (2%) deaths, none related to the AIGISRx.

"CIED infections are increasing in frequency, are associated with substantial morbidity, mortality, and cost, and present significant challenges to patients and for the physicians who provide care for them," stated Charles A. Henrikson, MD, FHRS, Oregon Health Sciences University, Portland, Oregon. "The CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers which will provide us with useful clinical information on the use of the AIGISRx Envelope in a variety of patients who are at high risk for CIED infection." The CITADEL (NCT01043861) & CENTURION (NCT01043705) studies are registered in the ClinicalTrials.gov registry of federally and privately supported clinical trials conducted in the US and around the world.

This study was funded by TYRX, Inc.

About Heart Rhythm Society

Heart Rhythm 2013 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.

About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx® Antibacterial Envelope, designed to reduce surgical site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by pathogens responsible for the majority of CIED infections, including "superbugs" such as methicillin-resistant S. aureus (MRSA).*

For more information, please visit http://www.TYRX.com or http://www.HeartDeviceInfection.com.

*Data on file at TYRX and published Hansen et al. Pacing Clin Electrophysiol. 2009; 32(7):898-907.

CONTACTS:

Robert White
President and Chief Executive Officer
TYRX, Inc.
732.246.8676
info@TYRX.com
For Media:
Kureczka/Martin Associates
Joan Kureczka
415.690.0210
Joan@Kureczka-Martin.com

Joan Kureczka | EurekAlert!
Further information:
http://www.TYRX.com
http://www.HeartDeviceInfection.com

More articles from Health and Medicine:

nachricht Laser activated gold pyramids could deliver drugs, DNA into cells without harm
24.03.2017 | Harvard John A. Paulson School of Engineering and Applied Sciences

nachricht What does congenital Zika syndrome look like?
24.03.2017 | University of California - San Diego

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Giant Magnetic Fields in the Universe

Astronomers from Bonn and Tautenburg in Thuringia (Germany) used the 100-m radio telescope at Effelsberg to observe several galaxy clusters. At the edges of these large accumulations of dark matter, stellar systems (galaxies), hot gas, and charged particles, they found magnetic fields that are exceptionally ordered over distances of many million light years. This makes them the most extended magnetic fields in the universe known so far.

The results will be published on March 22 in the journal „Astronomy & Astrophysics“.

Galaxy clusters are the largest gravitationally bound structures in the universe. With a typical extent of about 10 million light years, i.e. 100 times the...

Im Focus: Tracing down linear ubiquitination

Researchers at the Goethe University Frankfurt, together with partners from the University of Tübingen in Germany and Queen Mary University as well as Francis Crick Institute from London (UK) have developed a novel technology to decipher the secret ubiquitin code.

Ubiquitin is a small protein that can be linked to other cellular proteins, thereby controlling and modulating their functions. The attachment occurs in many...

Im Focus: Perovskite edges can be tuned for optoelectronic performance

Layered 2D material improves efficiency for solar cells and LEDs

In the eternal search for next generation high-efficiency solar cells and LEDs, scientists at Los Alamos National Laboratory and their partners are creating...

Im Focus: Polymer-coated silicon nanosheets as alternative to graphene: A perfect team for nanoelectronics

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are less stable. Now researchers at the Technical University of Munich (TUM) have, for the first time ever, produced a composite material combining silicon nanosheets and a polymer that is both UV-resistant and easy to process. This brings the scientists a significant step closer to industrial applications like flexible displays and photosensors.

Silicon nanosheets are thin, two-dimensional layers with exceptional optoelectronic properties very similar to those of graphene. Albeit, the nanosheets are...

Im Focus: Researchers Imitate Molecular Crowding in Cells

Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to simulate these confined natural conditions in artificial vesicles for the first time. As reported in the academic journal Small, the results are offering better insight into the development of nanoreactors and artificial organelles.

Enzymes behave differently in a test tube compared with the molecular scrum of a living cell. Chemists from the University of Basel have now been able to...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

International Land Use Symposium ILUS 2017: Call for Abstracts and Registration open

20.03.2017 | Event News

CONNECT 2017: International congress on connective tissue

14.03.2017 | Event News

ICTM Conference: Turbine Construction between Big Data and Additive Manufacturing

07.03.2017 | Event News

 
Latest News

Argon is not the 'dope' for metallic hydrogen

24.03.2017 | Materials Sciences

Astronomers find unexpected, dust-obscured star formation in distant galaxy

24.03.2017 | Physics and Astronomy

Gravitational wave kicks monster black hole out of galactic core

24.03.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>