News | March 02, 2008

FDA Clears Cardiac Rhythm Medical Device Anti-Bacterial Envelope

March 3, 2008 – The FDA granted 510(k) clearance for the AIGISRX CRMD Anti-Bacterial Envelope by Tyrxpharma, a cardiac rhythm medical device intended to immobilize and reduce bacterial infection of a pacemaker or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body.

AIGISRX CRMD contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in CRMD related endocarditis, including Methicillin Resistant Staphylococcus Aureus (MRSA). This device is only intended to be used in conjunction with pacemakers and implantable cardioverter defibrillators

The envelope is constructed of knitted filaments of polypropylene coated with a proprietary resorbable polymer that elutes the antimicrobial agents rifampin and minocycline for a minimum of 7 days to reduce the risk of infection of the implanted CRMD following surgery.

According to the manufacturer, AIGISRX CRMD also demonstrated in vivo effectiveness in reducing infection compared to control in a series of animal studies in which CRMDs were placed into AIGISRX CRMD envelopes and implanted into subcutaneous pockets inoculated with various bacterial strains, representing a majority of the infections associated with CRMD related endocarditis. Both AIGISRX CRMD and the controls (CRMD without envelope) were inoculated and observed for a minimum of 7 days to validate the presence of infection in the animals. The bacteria tested included Staphylococcus epidermidis, Acinetobacter baumanii, Staphylococcus capitis and
Escherichia coli, and separately, Staphylococcus aureus which represent a majority of the infections reported in CRMD-related endocarditis. It should be noted that the in vitro and in vivo activity of the AIGISRX CRMD antimicrobials is variable against non-epidermidis strains of coagulase-negative staphylococci.
According to a recent study presented during the Heart Rhythm Society 2006 Scientific Sessions, the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82 percent and for ICDs 3.71 percent.
Recent market research indicates that more than 400,000 CRMDs are implanted each year in the U.S.
“We are thrilled to have reached this value-creating milestone with the FDA clearance of AIGISRX CRMD,” said Bill Edelman, CEO of TyRx Pharma. “With over 400,000 annual U.S. implants of CRMDs, we believe AIGISRX CRMD will become a valuable tool in the effort to suppress bacterial infection of CRMD pockets.” Mr. Edelman continued, “We anticipate AIGISRX CRMD U.S. national commercial distribution to begin within the quarter following this FDA clearance, with full market release coinciding with the Heart Rhythm Society Heart Rhythm 2008, the premier conference on cardiac arrhythmias in San Francisco May 14-17, 2008,” Rabih O. Darouiche, M.D., director of the Center for Prostheses Infection at Baylor College of Medicine, Houston, Texas commented, “This first-in-class anti-infective approach is likely to yield tremendous benefit to both patients and clinicians taking into consideration the growing risk of infection and the severe consequences for those patients who may develop an infection.”

For more information, please visit www.tyrxpharma.com

Related Content

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
Aug.
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...
Cardiologs ECG Analysis Platform Receives FDA Clearance
Technology | ECG Monitoring Services| July 13, 2017
Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its...
Overlay Init