TYRX® Receives New Product Innovation Award

AIGISRx Antibacterial Envelope for Pacemakers and Defibrillators Recognized by Frost & Sullivan

Monmouth Junction, NJ (September 14, 2012) – TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with cardiovascular implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, announced today that Frost & Sullivan has named the AIGISRx Antibacterial Envelope as the recipient of its prestigious New Product Innovation Award for 2012.

“To date TYRX’s AIGISRx is very unique in the fact that it is the first and only antibacterial product of its kind to receive U.S. Food and Drug Administration (FDA) clearance. The product not only helps in stabilizing the pacemaker or ICD, but it also helps reduce infection by delivering antibiotics directly to the
surgical site in the first 7 to 10 days following implantation,” said Darshana De, IP and Best Practices Analyst from Frost & Sullivan.

The AIGISRx Antibacterial Envelope is designed to address surgical-site infections which are expensive to treat and have a significant impact on patients and hospitals.

Patients suffering from surgical-site infections following CIED procedures:
• spend an average of two extra weeks in the hospital
• undergo repeat surgical procedures to treat the infection
• cost the facility an average of $72,485
• experience significant increases in morbidity & mortality, with 1-year mortality rates of 26.5% to 35.1%, depending on device type

The recipient of the Frost & Sullivan New Product Innovation Award is selected after rigorous analysis of industry’s leading companies who demonstrate outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

“Since TYRX was founded, we have been working diligently to research, develop, and commercialize technologies which help reduce surgical-site infections and improve patient outcomes,” remarked Robert White, President and CEO of TYRX. “Our team appreciates Frost & Sullivan’s acknowledgement of our
product leadership and innovation.”

About TYRX, Inc.
TYRX, Inc., headquartered in Monmouth Junction, New Jersey, is a pioneer in the development, manufacture, and distribution of innovative, implantable combination drug-device products including the AIGISRx Antibacterial Envelope. The AIGISRx Envelope is specifically designed to aid in the stabilization
of CIED placement as well as to help 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 organisms representing the majority of the infections reported in CIED-related endocarditis, including “superbugs” or MRSA.*

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

4 Comments

Thanks for the info

by ElectricFrank - 2012-09-17 01:09:24

That should be helpful for some of our members who have had problems with infections.

frank

Sounds great

by Grateful Heart - 2012-09-18 12:09:00

I have heard about this. I wonder if this could help with my scar eruptions. I'm sure it can't hurt. Hopefully won't need a replacement for a few though, no rush. LOL

Ahhh TYRX

by PacerRep - 2012-09-19 01:09:11

First off, Great product.

The problem is that with current DRG (federal billing guidelines) the TYRX is not a re-imburseable product. The hospital is going to get a set amount of money from the insurence based on federal guidelines. That money is then divided up amongst multiple entities...Hardware, lab time, staff, doctor salary, insurence, sterilization etc etc. What is left over is what the hospital makes on the proceedure. These TYRX bags cost around $900 bucks. If a hospital uses one, then it comes out of their bottom line, don't expect to see a big push to use these.

They are also a pain in the ass when it comes to a battery replacement (not your problem). The scar tissue weaves in the mesh of the TYRX bag and it takes a while to break it free.

Another set-back is that the people at AIGISRx have not shown any conclusive data that this actually works (although it's kinda obvious it does) they have not done the proper clinical trials to support their claim.

Again great product, I would definitely want one if I had a proceedure, but the hard truth is the hospitals aren't going to shave off $900 bucks of their profit on each case, it adds up to big bucks over the year. Unless you throw a fit and threaten to go to a different hospital, don't expect to get one.

Response to "Ahhh TYRX" Posting

by rmansfield - 2012-09-27 02:09:59

Thank you for your feedback on the AIGISRx Antibacterial Envelope.

You bring up a several important points for the PacemakerClub.com community to understand, so I thought I would clarify a few things.

Health care costs are an important reality of health care delivery in the U.S. Toward that end, there are 4 important developments affecting reimbursement for the AIGISRx Antibacterial Envelope:

1. Effective October 1st of this year (2012), the Centers for Medicare and Medicaid (CMS) is increasing reimbursement for heart device implantation procedures (pacemakers, defibrillators) an average of 4%, which will more than cover the cost of the AIGISRx Antibacterial Envelope.

2. Effective October 1st of last year (2011) CMS created new ICD-9-CM procedure code (17.81) for “insertion of antimicrobial envelope” with heart device procedures (pacemakers and defibrillators). This new ICD-9-CM code is important because it can be used, in part, to track AIGISRx Antibacterial Envelope use with heart device procedures performed during the next two years. At the end of this two-year period, CMS will be able to increase payments to hospitals for heart device procedures to cover the cost of the AIGISRx Antibacterial Envelope.

3. TYRX is currently following all of the appropriate procedures to obtain a pass-through reimbursement code (C-code) for the cost of the AIGISRx Antibacterial Envelope, when it is utilized as part of an outpatient procedure. This is important because a significant number of heart device implantations are done in an outpatient setting.

4. Effective October 1st of this year (2012), CMS is designating Surgical Site Infections (SSI) following heart device implantation as a condition subject to the Hospital Acquired Condition (HAC or ‘Never-pay’) payment provision. Specifically, CMS considers these infections to be reasonably preventable and will pay for the original surgery, but will not reimburse hospitals at a higher rate for treating heart device infection. This is important because it represents an ongoing effort by CMS to improve patient care by reducing SSIs. It will start in the hospital inpatient setting, but will likely move to also cover the outpatient setting, as all past legislation of this kind has shown.

Physician implantation & explantation are fairly straightforward and there are numerous techniques to perform them that have proven safe, effective, and reproducible. Adding a few extra minutes to implant or explant the AIGISRx, to help reduce patient mortality, which can be as high as 35%, is an important reason to use the product. The risk of infection is increased with battery replacements. Battery replacements can be required every 3 to 5 years with some devices, and this may be a useful time to consider use of the AIGISRx Antibacterial Envelope.

Clinical data supporting the efficacy of the AIGISRx Antibacterial Envelope have been presented by several groups:

1. The results of the COMMAND study of the AIGISRx Antibacterial Envelope were published in PACE, a peer-reviewed cardiac electrophysiology journal, in 2011. The COMMAND Study results demonstrated 70% fewer infections in procedures that utilized the AIGISRx Antibacterial Envelope, compared to previously published cohorts of comparable procedures that did not include AIGISRx.

2. More recently, the results of a case-matched cohort study of heart device implantation procedures (pacemakers and defibrillators) at high-risk for infection from Vanderbilt University presented at this years’ American College of Cardiology meetings reported significantly fewer infections in procedures that utilized the AIGISRx Antibacterial Envelope, compared to those that did not (0% with the AIGISRx vs. 3% without the AIGISRx).

In addition there are two large on-going prospective studies of the AIGISRx Antibacterial Envelope (CITADEL and CENTURION).

It is important for all Pacemaker Club patients and caregivers to remember that heart device patients who contract an infection, spend an average of 2 extra weeks in the hospital, undergo repeat surgical procedures to treat the infection, cost the facility an average of $72,485, and experience significant increases in morbidity & mortality, with 1-year mortality rates of 26.5 to 35.1%, depending on device type.

We strongly encourage all pacemaker and implantable defibrillator patients to discuss the AIGISRx Antibacterial Envelope with your physician the next time you are scheduled for a pacemaker or defibrillator implant. Additional information can be round at www.HeartDeviceInfection.com including a helpful Patient Education Brochure.

Thank you again for your comments and we appreciate the opportunity to clarify the record.

Best Regards,
Randy

Randy Mansfield
Vice President of Marketing
TYRX, Inc.

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