News | May 18, 2009

TYRX Presents Results of AIGISRX Antibacterial Envelope Retrospective Registry

May 18. 2009 - TYRX Inc. announced the initial, interim clinical results from its AIGISRX Antibacterial Envelope Retrospective Registry during Heart Rhythm 2009 in Boston last week.

AIGIS is an antibacterial mesh envelope developed to deliver antimicrobial agents that help provide protection against infections associated with implanted pacemakers and cardioverter defibrillators. AIGIS also securely holds a pacemaker (PM) or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body.

During the Heart Rhythm Society 2009 Annual Scientific Sessions, TYRX held an AIGIS Retrospective Registry (ARR) investigator’s meeting at which the study’s early results were presented and discussed. The intent of the multicentered, retrospective study is to define the implant success rate and incidence of infection, in patients implanted with cardiac rhythm management device (CRMD) and the AIGIS.

To date, 393 patients from seven clinical sites have been enrolled in the study with a 98 percent success rate of CRMD implantation, with the 2 percent of failures not being AIGIS related, the company said. Of the 393 patients enrolled, at least one follow-up visit has been completed for 254 patients with a mean follow-up period of 59 days and a median follow-up of 32 days. Two studies report the median time to CRMD infection. One stated median time was 14 days and a second reported a median time to infection of 52 days.

“When one looks at the characteristics of the patients enrolled in the AIGIS Retrospective Registry to-date it is noteworthy that there is a high percentage of patients who are, according to published studies, at high risk of CRMD-related infections,” said Dan Lerner, M.D., TYRX’s chief medical officer. “Of the three generator pocket infections reported to date, two occurred in patients who had prior explants for infection within the past six months. Importantly, these early data indicate AIGIS does not interfere with CRMD implant success. The AIGIS Retrospective Registry continues with the expectation that, with the enrollment of three additional clinical sites, TYRX will collect data on over 500 AIGIS patients, representing more than 15 percent of the 3,000 AIGIS implanted to date. The company plans to continue the AIGIS Retrospective Registry follow-up period will provide clinicians greater insight into the clinical utility of AIGIS.”

For more information:

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems| July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Overlay Init