receiving a heart DeviCe implant?

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1 innovate transform improve receiving a heart DeviCe implant? The new, revolutionary aigisrx r Fully resorbable antibacterial envelope may help.

2 Pacemakers Save Lives... but there are risks You should be aware of the potential risk of infection. If you or anyone you know will be undergoing a heart device implant procedure, it is recommended that you consult with your doctor about the risk of surgical site infections, and what can be done to prevent them. Over 2 million Americans are alive today because of Cardiac Implantable Electronic Devices (CIEDs), also referred to in this pamphlet as heart devices, and include pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy. These devices are specifically designed to help keep your heart functioning normally. But, there is up to a 7% chance that the device will become infected at the time of surgery. 1 Many preventative measures are taken by your doctor to safeguard against surgical site infections. However, extra precaution is warranted for heart device surgery, since the risk is especially high for many patients.

3 Who is at risk? Anyone who is undergoing heart device surgery is at risk of a surgical site infection, but there are some factors that increase the risk and should be discussed with your doctor. These include reduced kidney function, kidney failure, diabetes, a previous device infection, or regularly taking corticosteroids or anticoagulants. 2-5 patients undergoing replacement heart device surgery are also at a higher risk of contracting a surgical site infection. What are the consequences of a surgical site infection? surgical site infections are difficult and time-consuming for your physician to manage. You may need to be readmitted to the hospital to treat the infection and for additional surgery to replace the device. In severe cases, surgical site infections can be life-threatening. Types of heart Devices Pacemaker implantable cardioverter Defibrillator (icd) cardiac resynchronization Therapy (crt) 3

4 The good news: The revolutionary AIGISrx R MAY help prevent Surgical site infections FDA-cleared, clinically-proven, innovative technology The AIGISrx Technology has been implanted in thousands of patients, with impressive results. Multiple clinical studies have shown that patients at high risk for heart device infection who are implanted with the AIGISrx had % fewer infections than similar patients who did not receive the AIGISrx. 6-9 What makes the AIGISrx R Envelope so unique and helpful? First, the Envelope is an antibacterial, mesh sleeve that holds the heart device when implanted in the chest. It contains a combination of two powerful antibiotics, minocycline and rifampin, which are released locally right to the surgical site. This local drug release may help prevent a wide range of bacterial infections. Second, and equally important, is the fact that the Envelope is the only antibacterial device available for heart device implants and it is fully resorbable. The mesh Envelope fully resorbs, which means that it completely disappears, leaving nothing remaining in the body. This is important for your surgeon to know, if or when your heart device may need to be revised or replaced. Third, the Envelope effectively stabilizes the heart device, reducing the chance for movement or skin erosion.

5 Time sequence demonstrating bioresorbability of aigisrx r after ~9 weeks aigisrx r after implantation 10 Envelope is eluting both antibiotics. a simple procedure The doctor performing your heart device surgery simply places the device into the aigisrx Envelope prior to inserting it beneath your skin. It s that simple. aigisrx r at 4 weeks 11 Envelope is dissolving into fragments. aigisrx r at ~9 weeks 12 Mesh has no physical presence and is fully resorbed. The aigisrx r fully resorbable Antibacterial Envelope holds the heart device in place and helps prevent surgical site infection. 5

6 Common Questions about heart device Infection What questions should I ask before surgery? The doctor is a patient s best ally in preventing surgical site infection. Before surgery, ask what to expect and discuss infection concerns. Here are a few questions to help get the conversation started: What is your experience with surgical site infection related to heart devices? What measures do you take to help safeguard against surgical site infection before, during, and after surgery? Do you use new antibacterial technology such as the AIGISrx R Antibacterial Envelope? What should I know about the antibiotics used in the AIGISrx R? There are specific types of bacteria responsible for over 70% of heart device infections, many of which are becoming resistant to commonly used antibiotics. Vancomycin and Cefazolin, two of the more common antibiotics used before heart device surgery, are very effective drugs. However, both can have limited effects when used on their own, and even when used in combination. For example, Cefazolin does not have significant activity against methicillin-resistant S. aureus, and Vancomycin does not have significant activity against Gram-negative bacteria. Clinical studies have demonstrated that patients with AIGISrx Envelopes have significantly fewer heart device infections than similar patients who did not receive an AIGISrx Envelope. 6-9

7 how do i know if i have a surgical site infection? The symptoms of a heart device surgical site infection include: swelling, pain, or redness at the incision site Discharge at the incision site fever skin erosion how is a heart device surgical site infection treated? A heart device surgical site infection is usually treated by removing and replacing the device. A new device cannot be implanted until the infection is treated and eliminated. This means after the device is removed, the patient will be given antibiotics for up to six weeks. unfortunately, this can lead to a longer hospital stay, generally lasting about 14 days. 13 If needed, patients also get an external pacemaker until the infection is eliminated. for more information, go to: 7

8 aigisrx r is an fda-cleared, fully resorbable antibacterial envelope that may help reduce your risk of surgical site infection. for more information, go to and ask your doctor about aigisrx r today. Mkt rev 1 1 Tarakji et al. heart rhythm. 2010; 7(8): bloom h et al. pacing Clin electrophysiol. 2006; 29(2): herce b et al. Europace. 2013; 15(1): lekkerkerker JC et al. heart. 2009; 95(9): sohail Mr et al. Clin infect Dis. 2007; 45(2): kolek MJ et al. pacing Clin electrophysiol. 2013; 36(3): henrickson Ca, Citadel & Centurion studies. presented at the late breaking Clinical trials session at the european heart rhythm association (ehra), Europace bloom h et al. pacing Clin electrophysiol. 2011; 34(2): Mittal s et al hrs scientific session, po 05-43, ny/nj valley health system. 10 huntington study tr Data on file, huntington study tr sohail Mr et al. arch inten Med. 2011; 171(20): Copyright 2013, tyrx, inc. all rights reserved. tyrx, inc. 1 Deer park Drive, suite G, Monmouth Junction, nj