EP Lab Digest - February 2008 - (Page 38)

38 NEWS FEBRUARY 2008 TyRx Pharma, Inc. Announces FDA ™ 510(k) Clearance of the AIGISRX Cardiac Rhythm Medical Device (CRMD) Anti-Bacterial Envelope The AIGISRX™ CRMD is an Innovative Mesh Envelope Designed to Immobilize and Reduce Bacterial Infection of a Pacemaker or ICD When Implanted in the Body Continued from page 1 IGISRX™ CRMD has two functions. It is intended to securely hold a pacemaker or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body. In addition, 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 MRSA.This device is only intended to be used in conjunction with pacemakers and ICDs. AIGISRX™ CRMD 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. In in vitro studies, AIGISRX™ CRMD demonstrated antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes and Proteus mirabilis. 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. First Standardized Cardiac Pacing Exam for Japanese Allied Professionals International Board Sees Partnership as Model for Future Global Testing he International Board of Heart Rhythm Examiners (IBHRE) issued the first standardized cardiac pacing exam for Japanese allied professionals.This marks the first time the IBHRE exam, considered the highest benchmark of professional competency in cardiac pacing, defibrillation and electrophysiology, will be tailored to the needs of a global health care system outside of the U.S. “With the ICD growth rate around 50 percent and no signs of decreasing, the importance of credentialing Japanese professionals is all the more urgent,”said Charles J. Love, MD, FACC, FAHA, FHRS, CCDS, President of the IBHRE Board of Directors. “Newer devices are highly complex and require a much greater level of technical knowledge and expertise to implant and maintain.” Formerly known as NASPExAM, IBHRE was founded in 1985 to provide an examination in the fields of cardiac pacing and implantable cardioversion defibrillation. Originally created for physicians and surgeons, the exam was later developed for allied professionals to raise the level of professionalism and academic credibility in cardiac pacing. The knowledge base of the exam, which includes device functions, is for the most part a global standard. Patient management questions, however, and an understanding of the clinical culture and medicines used in Japan were considered when tailoring the exam. Translation was also taken into account as word usage and meanings may differ. IBHRE hopes its partnership with Japan Heart Rhythm Society (JHRS) will serve as the model for future exam tailoring and administration in countries such as China, Russia, and India. “Given the growing number of heart rhythm patients around the world and the variations of health care systems globally, the need for certification and credentialing is of utmost importance to enhance positive patient care,” said Love. The Japanese Ministry of Health has mandated that in addition to allied professionals, sales representatives, technical advisors and anyone else having contact with patients from the medical device industry must be certified.This mandate is meant to ensure a meaningful standard of knowledge for those involved in assisting physicians and other health care workers in the implantation and management of pacemakers and ICDs. More than 7,000 individuals in the U.S. have taken the IBHRE exam to date.A full 644 allied professionals in Japan are already signed up to take the first of its kind computer-based test. Results will be announced in March 2008. T A According to a recent study presented during the Heart Rhythm 2006 Scientific Sessions, the University of Pittsburgh Medical Center noted that the 2003 national incidence of infection was estimated to be 5.82% for pacemakers and 3.71% for ICDs. 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.” He 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 Heart Rhythm 2008, the premier conference on cardiac arrhythmias in San Francisco May 14-17, 2008.” Rabih O. Darouiche, MD, Director of the Center for Prostheses Infection at Baylor College of Medicine in Houston, 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." This is the third in a series of implantable combination drug—device products for which TyRx has gained FDA Premarket Application clearance. In December 2005, FDA granted 510(k) clearance for PIVIT™, TyRx’s 1st bioresorbable polymer coated surgical mesh product. In July, 2006, FDA granted TyRx 510(k) clearance for PIVIT™ AB, TyRx’s Antimicrobial Surgical Mesh coated with rifampin and minocycline. The unique properties associated with the PIVIT™ surgical mesh products provide excellent handling characteristics that facilitate precise placement during surgical repair of soft tissue defects, leaving less implant material following the resorption of the bioresorbable polymer coating.

Table of Contents Feed for the Digital Edition of EP Lab Digest - February 2008

EP Lab Digest - February 2008 Creating the U-M Center for Arrhythmia Research: Interview with José Jalife, MD Texas Cardiac Arrhythmia Institute and St. David’s Medical Center Launch State-of-the-Art Training Center Contents Letter from the Editor Spotlight Interview: Caritas St. Elizabeth’s Medical Center 10-Minute Interview: Sue Deck, BS, RN, RCES Keeping Pace With a Blog Roundtable Discussion on Cryoablation Procedures Email Discussion Group: February 2008 Events Calendar Industry News and Products Classifieds Advertisers Index

EP Lab Digest - February 2008

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