WITH ENDEXO ADVANCED TECHNOLOGY TECHNOLOGY DESIGNED TO IMPROVE ADVANCED TECHNOLOGY SOLUTIONS OUTCOMES* PATIENT OUTCOMES COST EFFECTIVE

Transcription

1 WITH ENDEXO TECHNOLOGY ADVANCED TECHNOLOGY ADVANCED TECHNOLOGY SOLUTIONS DESIGNED TO IMPROVE PATIENT OUTCOMES DESIGNED TO IMPROVE OUTCOMES* COST EFFECTIVE

2 ADVANCED TECHNOLOGY DESIGNED TO IMPROVE OUTCOMES* Reduces the risk of thrombus accumulation on implantable vascular devices from 83% to 96%. * Reinventing the standard of care by reducing the risk of thrombus accumulation. EVOLVE TO ADVANCED CATHETER TECHNOLOGY COST EFFECTIVE Reduction in thrombus accumulation results in a decrease in catheterrelated thrombus/ occlusions and the associated costs. Vascular access procedures are one of the most common procedures performed on patients in hospitals. AngioDynamics is committed to creating strategic partnerships with healthcare institutions to address today s changing healthcare environment by developing advanced technology that are safe, cost effective and designed to improve * The Endexo catheter is designed to reduce thrombus accumulation. The reduction of thrombus accumulation (based on platelet count) is supported by acute in-vitro testing. Pre-clinical in-vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation. patient outcomes.

3 COMMON VASCULAR ACCESS DEVICE COMPLICATIONS THROMBOSIS OCCLUSION PICC-related upper extremity DVT occurs at an average rate of %1 with an average cost of $15,9732 per incidence. 25% average occlusion rate, most frequent complication of vascular access devices.3 Single dose of thrombolytic $ * CATHETER-RELATED INFECTIONS Estimated 250,000 blood stream infections occur annually in the United States, resulting in significantly higher mortality rates and costs in hospital inpatients.5 *Market price for single dose of CathFlo 1. Chopra V, Anand S, Krein SL, Chenoweth C, Saint S. Bloodstream infection, venous thrombosis, and peripherally inserted central catheters: reappraising the evidence. Am J Med Aug;125(8): doi: /j.amjmed Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014;15(5): Moll S, Kenyon P, Bertoli L, De Maio J, Homesley H, Deitcher SR. Phase II Trial of Alfimeprase, a Novel-Acting Fibrin Degradation Agent, for Occluded Central Venous Access Devices. J Clin Oncol Jul 1;24(19): Sapienza SP, Ciaschini DR. Intraluminal Volume Dose Alteplase for the Clearance of Occluded Peripherally Inserted Central Catheter Lines at a Long-Term Acute Care Hospital: Efficacy and Economic Impact. Hosp Pharm Mar;50(3): doi: /hpj Stevens V, Geiger K, Concannon C, Nelson RE, Brown JK, Dumyati G. Inpatient costs, mortality and 30-day re-admission in patients with central-line-associated bloodstream infections. Clin Microbiol and Infect (2014);20(5): doi: / Virchow s Triad Vessel Injury Hypercoagulability Venous Stasis Common Vascular Access Complications Catheter Occlusions CLABSI DVT VTE Chopra V, Flanders SA, Saint S, Woller SC, O Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results from a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med Sep 15;163(6 Suppl):S1-40. doi: /M

4 MICHIGAN APPRORIATENESS GUIDE INTRAVENOUS CATHETERS Selecting a vascular device will always be a nuanced clinical decision. But a little bit of MAGIC almost certainly helps... Naomi O Grady, MD This work represents an important achievement the first time so many specialties were brought together to focus on vascular access... Lisa Gorski, RN Our research is focused on: (a) understanding drivers of PICC use and preventing inappropriate insertion; (b) developing statistical models that predict PICC complications; and (c) designing and implementing interventions to prevent adverse events such as occlusion, thromboembolism, and infection. We work closely with a number of key partners to achieve these goals. ADDRESSABLE COMPLICATIONS: PICC-RELATED We ve gravitated towards using this device [PICC] over central venous catheters for good reasons, and it may still be the best choice for some people. However, our findings suggest that patients and physicians should carefully review the risks and benefits when it comes to placing PICCs, especially with respect to blood clots. Our study shows that this risk may be higher than previously recognized and suggests that there is no one-size-fits-all approach when considering use of these devices. Vineet Chopra, MD For healthcare quality officers and payers, MAGIC is highly relevant because it will facilitate measuring practice and inform quality improvement efforts... Scott Woller, MD MAGIC is a set of recommendations that defines when a particular vascular access device is appropriate for use. Written by 14 of the world s foremost experts and a patient, MAGIC covers the most commonly used IV devices, indications, patient types, and settings for use. In the world of vascular access, there is nothing else like it. Chopra V, Flanders SA, Saint S, Woller SC, O Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenouse Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results from a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med Sep 15;163(6 Suppl):S1-40. doi: /M Mostafavi, B. U-M Press Release. Commonly used catheters double risk of blood clots in ICU and cancer patients. May 19, Available at archive/201305/commonly-used-catheters-double-risk-blood-clots-icu-and. Chopra V, Flanders SA, Saint S, Woller SC, O Grady NP, Safdar N, Trerotola SO, Saran R, Moureau N, Wiseman S, Pittiruti M, Akl EA, Lee AY, Courey A, Swaminathan L, LeDonne J, Becker C, Krein SL, Bernstein SJ; Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) Panel. The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results from a Multispecialty Panel Using the RAND/UCLA Appropriateness Method. Ann Intern Med Sep 15;163(6 Suppl):S1-40. doi: /M

5 HISTORY OF VASCULAR ACCESS MATERIALS EVOLVE TO ENDEXO TECHNOLOGY SILICONE POLYURETHANE COATED IMPREGNATED ENDEXO

6 COATED Catheter coatings are present on the catheter surface and known to elude off once they are placed inside the body and begin to lose their platelet adhesion resistance. IMPREGNATED Impregnated catheters claim to offer thrombusreducing properties in their pores, leaving the surface vulnerable to platelet adhesion. EVOLUTION TO ENDEXO ENDEXO Unlike other technologies that are superficial and/or transient, Endexo technology is present for the life of the catheter. EVOLUTION OF CATHETER TECHNOLOGY The Endexo polymer mixes with carbothane completely without altering the base properties. Due to the lower surface friction of the Endexomodified polymer, the material becomes essentially invisible to normal biological defense mechanisms. Thus platelet accretion, clot formation and histochemical reactivity is significantly reduced. 1 Endexo alters the surface chemistry of the device. 2 The surface reduces the rate of bioaccretion. 3 Endexo mixes into the parent polymer seamlessly. The non-stick characteristics of the Endexo material and resultant catheter construction reduce the adherence of blood components, such as platelets and thrombus. Not containing heparin, the Endexo technology may help to minimize complications associated with heparin. Additionally, the Endexo technology does not contain antibiotics or antimicrobial agents, aiding to reduce potential complications associated with bacterial resistance. The Endexo material is throughout the catheter (i.e., inside, outside and cut surfaces) and remains for the life of the device. In fact, the exposure of the BioFlo PICC to simulated implant flow conditions (i.e., temperature, flow, ph and time) demonstrated that the Endexo polymer concentration within the BioFlo PICC did not degrade or change over extended durations. Lareau R, Facchini F. A New Option for Short- or Long-Term Peripheral Access to the Central Venous System: A Product Technology Overview of the BioFlo PICC with Endexo Technology, with and without PASV Valve Technology AngioDynamics.

7 PERFORMANCE IN IN-VITRO EVALUATIONS BLOOD LOOP (IN VITRO): RESULTS High-magnification images of blood loop samples show that the BioFlo PICC has a marked reduction in thrombus when compared to control BioFlo PICC 5 F DL Catheter has no visible thrombus, fibrin sheath, or clot 5 F DL Competitive PICC Catheter with significant thrombus accumulation FACILITY NAME # OF PICCs PLACED DVT REDUCTION Academic Medical Center 1,251 85% Community Hospital % Community Hospital 1,212 36% Hospital Group % International Hospital 60 46% Health System 3,881 30% Academic Medical Center 52 55% 7,241 51% FACILITY NAME # OF PICCs PLACED tpa REDUCTION Children s Hospital % Community Hospital % Community Hospital 1,212 62% Hospital Group % 2,474 68% PERFORMANCE IN CLINICAL EVALUATIONS AVG REDUCTION WITH THIS DATA SET 51% DVTs 68% tpa Data on file. Data on file. Data was obtained during hospital product evaluations, several of these sites are working toward publications. Based on data collected at individual institutions, results may not be indicative of clinical experiences at other institutions. McLennan G, Kertesz M, Obuchowski N, Sands M. Flouroquinolone Based Surface Modifying Molecules Reduce Venous Thrombosis Rates Associated with PICC Lines. RSNA 2014 Scientific Assembly and Annual Meeting. Abstract. Sustar L, Kertesz M. Anti-Thrombogenic Non-Eluting Polyurethane PICC vs. Conventional Polyurethane PICC Upper Extremity DVT Rates AVA Annual Scientific Meeting. Poster Presentation. Rineair SA, Webb JL. Changing the Outcome for the Pediatric Peripherally Inserted Central Catheter Patient: Decreasing Occlusion Complications with the Implementation of an Alternative Peripherally Inserted Central Catheter AVA Annual Scientific Meeting. Poster Presentation. Corbin D, Crites L. Reducing Catheter-Related Complications with New Anti-Thrombogenic PICC AVA Annual Scientific Meeting. Poster Presentation. Simcock L, Salvador J, McInerney K, Bhavika P. A Retrospective Comparative Audit of Whether BioFlo PICCS Can Reduce the Incidence of Upper Extremity-Deep Vein Thrombosis in Patients with Sarcoma AVA Annual Scientific Meeting. Poster Presentation. Cox S, Wheeler K. Venous Thromboembolism Prevention: An Innovative Approach to Improving Quality and Safety in a Neuro ICU. Poster Presentation.

8 RISK REDUCTION: SINGLE CENTER PROSPECTIVE HOSPITAL STUDY 12.00% 10.00% 8.00% 6.00% 4.00% 2.00% 0.00% OCCLUSIONS Standard Polyurethane Anti-Thrombogenic Endexo BioFlo PASV PICC UEDVTs RISK REDUCTION: SINGLE-CENTER RETROSPECTIVE STUDY (24 Months) 30% Reduction in UEDVTs as Compared to Standard Polyurethane 3,891 Patients Endexo 8,323 Total Patients Polyurethane 4,432 Patients The complication rates were tracked and calculated for the following metrics: Occlusions: Standard polyurethane PICC 10.2%, anti-thrombogenic PICC 2.8% (73% reduction). UEDVTs: Standard polyurethane PICC 1.4%, anti-thrombogenic PICC 0.3% (80% reduction). Average Monthly Cathflo Expense: Standard polyurethane PICC $1,638.89, anti-thrombogenic PICC $ (64% reduction). 2.1% UEDVT Rate 30% Reduction in UEDVTs 3.1% UEDVT Rate These results are based on individual site experiences and may not be indicative of clinical evidence at other institutes. Crites L. Reducing Catheter-Related Complications With New Anti-Thrombogenic PICC (Abstract). Journal of the Association for Vascular Access. 2015;20(4):256. ANGM 145 US. Mostafavi, B. U-M Press Release. Commonly used catheters double risk of blood clots in ICU and cancer patients. May 19, Available at archive/201305/commonly-used-catheters-double-risk-blood-clots-icu-and. UEDVT= Upper Extremity Deep Vein Thrombosis Polenakovik H, Patton A, Jenkins J. Reducing Upper Extremity Deep Vein Thrombosis in the Peripherally Inserted Central Catheter Patient Association for Vascular Access Annual Scientific Meeting - National Harbor, MD. Poster Presentation (C-13). ANGM 148 US.

9 TRENDS IN HEALTH CARE ECONOMICS REGULATORY PAYORS HOSPITALS PHYSICIANS PATIENTS PICC PORT ANGIODYNAMICS IS THE ONLY PROVIDER OF ENDEXO TECHNOLOGY FOR VASCULAR ACCESS DEVICES. Changes in Reimbursement Bundled Payment Models Quality Measures More Transparency INCREASING NEED FOR CLINICAL AND HEALTHCARE QUALITY DATA DIALYSIS CATHETER MIDLINE ENDEXO PROVIDES A SAFE, COST- EFFECTIVE, ADVANCED TECHNOLOGY DESIGNED TO IMPROVE PATIENT OUTCOMES.

10 IMPORTANT RISK INFORMATION BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY INTENDED USE/INDICATIONS FOR USE: The BioFlo PICC with Endexo and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. CONTRAINDICATIONS: Venous thrombosis in any portion of the vein to be catheterized. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy. Orthopedic or neurological conditions affecting the extremity. Anticipation or presence of dialysis grafts or other intraluminal devices. Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy. Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site. Anatomical distortion of the veins from surgery, injury or trauma. Inadequate antecubital veins. Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures. Refer to Directions for Use provided with the product for complete instructions, warnings and precautions. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. BIOFLO PORTS WITH ENDEXO TECHNOLOGY INTENDED USE/INDICATIONS FOR USE: The BioFlo Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. When used with a power injectable needle, the BioFlo Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19 G or 20 G non-coring power injectable needle or 2 ml/sec with a 22 G noncoring power injectable needle. CONTRAINDICATIONS: Inadequate body size to support device, bacteraemia, sepsis, known or suspected allergic response to materials, infection, peritonitis, past irradiation of prospective insertion site, previous episodes of venous thrombosis or vascular surgical procedures at the postoperative placement site, local tissue factors will prevent proper device stabilization and/or access. Refer to package insert provided with the product for complete Instructions for Use, Contraindications, Possible Complications, Warnings and Precautions prior to using this product. CAUTION: Federal Law (USA) restricts this device for sale by or on the order of a physician. BIOFLO DURAMAX DIALYSIS CATHETER WITH ENDEXO TECHNOLOGY INDICATIONS FOR USE: The BioFlo DuraMax Dialysis Catheter with Endexo Technology is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adults. Catheters greater than 40 cm are intended for femoral vein insertion. CONTRAINDICATIONS: The catheter is intended for long-term vascular access only and should not be used for any purpose other than indicated in the instructions for use. WARNINGS AND PRECAUTIONS: Please see package insert for complete list of warnings and precautions. POTENTIAL COMPLICATIONS: Consult package insert for a complete list of potential complications. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. BIOFLO MIDLINE CATHETER WITH ENDEXO TECHNOLOGY INTENDED USE/INDICATIONS FOR USE: The BioFlo Midline catheter with ENDEXO technology is indicated for short-term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and the sampling of blood and blood products. CONTRAINDICATIONS: Venous thrombosis in any portion of the vein to be catheterized. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy. Orthopedic or neurological conditions affecting the extremity. Anticipation or presence of dialysis grafts or other intraluminal devices, including pacemakers. Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy. Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site. Anatomical distortion of the veins from surgery, injury or trauma. Inadequate antecubital veins. Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures. Refer to Directions for Use provided with the product for complete instructions, warnings, precautions and potential complications. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. AngioDynamics, the AngioDynamics logo, Navilyst Medical, PASV, BioFlo and the BioFlo logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Endexo is a trademark and/or registered trademark of Interface Biologics, Inc.AngioDynamics, the AngioDynamics logo, Navilyst Medical, PASV, BioFlo and the BioFlo logo are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. Endexo is a trademark and/or registered trademark of Interface Biologics, Inc.

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