Palindrome Precision Chronic Dialysis Catheter Family

Transcription

1 Precision Chronic Dialysis Family

2 Dialysis is Critical... Precision Family of s Increased tip visualisation 1 to aid in preserving access with initial placement. Promoting optimised patient care. From their patented design to their innovative coatings and precision tip technology, the Palindrome TM precision family of chronic haemodialysis catheters reflect the Covidien legacy of performance and confidence in innovation. High Flow Rates The precision dialysis catheter with it s internal lumen design, 14.5Fr diameter, and durable Carbothane * material is able to deliver 2, 3, 4 high flow rates. High tensile strength material and internal lumen design optimise inner diameter integrity without 2, 3, 5, 6 compromising flexibility or kink resistance Dependable Patency Tal VenaTrac Insertion Stylets Over the wire insertion stylets allow for an over the wire insertion technique, creating a staggered tip effect for smoother left sided or subclavian catheter placements and eliminates the need to use a pull apart sheath. When compared to the sheath insertion, this design: Reduces risk of air embolism 13 Reduces blood loss 13 Promotes over the wire catheter exchanges 2 Allows for sheathless catheter insertions 4 Symmetric tip design and laser-cut side slots promote catheter patency. 7 Reduced Intervention Rate Specifically designed side slots reduce the likelihood of positional occlusion 8 Laser-cut surfaces designed to discourage clot formation and minimise debris attachment Tip design promotes continuous flow between dialysis treatments 2, 9 Reduces Recirculation The precision catheter reduces recirculation rates to meet KDOQI guidelines when in forward or reverse flow. 10 In one clinical study, SI silver ion antimicrobial dialysis catheter had statistically significant results showing 6x fewer instances of surgical re-intervention due to thrombosis as compared to a split-tip catheter design. ( catheter = 5, 2, 4, 5, 14 Split Tip = 32, n = 200, p <.001) In another trial, a trend toward statistical significance was observed for Surgical or Radiological intervention favouring catheter when compared to a split tip design. (Palindrome = 2, 4, 5, 14 18, Split Tip = 29, n = 598, p =.079) Studies show that dialysis lines are frequently reversed 11 When lines are reversed, blood recirculation increases 12 Effectiveness and Durability Designed for the Patient...Confidence is Essential Average Recirculation Rates in Reverse Flow % 0 Staggered Tip 13% NKF / KDOQI Guidelines <5% Split Tip 1% Precision Covidien s dialysis catheter back-end design has been setting the standard of quality for over twenty years: Halkey-Roberts * clamps and Ultem * adapters are composed of durable materials Silicone extensions minimise kinking or crimping 3, 6 Testing is based on Pre-clinical animal data

3 The Clinical Challenge Early Failure Poor tip position accounts for 20% of early catheter removals 15 Performance and durability of the catheter have been shown to improve by positioning the catheter tip within the right atrium 16 Post-insertion, early cause of low catheter blood flow rate include catheter malposition and other mechanical problems 17 Paying careful attention to catheter tip position could reduce the early failure rate 18 Precision Dialysis Palindrome precision dialysis catheter allows the inserting physician to distinguish the functional tip of the catheter and visualise the accurate placement of the tip into the right atrium using fluoroscopy and x-ray. 1 The tungsten marker band is securely attached to the catheter using a heat bonded process. Product testing demonstrates a robust attachment to the catheter with no detectable delamination in vitro. 4, 5 Approximately 4.5cm 14 Palindrome TM 2.26cm Shear Flow Intensity Increasing tip visualisation Technology in practice 1) precision dialysis catheter Radiopaque tungsten marker band allows the inserter to distinguish the functional tip of the catheter and visualise the placement of the tip in the right atrium on fluoroscopy and x-ray. 1 2) Enhanced laser-cut side slots In a computational model, the laser cut side slots have been enhanced to reduce total shear stress on the inflow side slot: adding an additional benefit to the laser cut side slots of the Palindrome family of catheters. 8 3) Optimised tip geometry Aids in reduction of insertion force when using the Tal VenaTrac insertion stylets to place a catheter. 2 Covidien s precision dialysis catheter facilitates increased tip visualisation and accurate tip placement. 1 Precision Symmetric Tip Dialysis

4 The Clinical Challenge: Clotting As many as 40% of catheter failures are attributed to venous thrombosis and fibrin sheath formation 17 Approximately 17%-33% of catheter removals are attributed to thrombosis 19 Complications from thrombosis result in inadequate flow rates, longer dialysis times and increased costs 20 Non-Eluting Heparin Coating Technology Covidien s non-eluting heparin coating covers the external surface of the catheter from tip to cuff, and internally from tip to adapters, to provide protection. The heparin coating has a triple-action formula: Heparin: Anti-Thrombogenic Negative Charge: Non-Thrombogenic Hydrophilicity: Non-Thrombogenic Decreasing the likelihood of clot formation. Inhibiting fibrin sheath propagation. Technology in practice: When compared to uncoated catheter 1) Decreases likelihood of clot formation 2, 5, 14 In vivo testing demonstrated an 82% reduction in thrombus accumulation. In vitro testing showed a 60% reduction in platelet adhesion on the surface as compared to non-coated catheters. 14 2) Inhibits fibrin sheath propagation Supported by in vivo data, the non-eluting heparin coating has been shown to inhibit fibrin sheath propagation as compared to non-coated catheters. 4 3) Long-lasting effectiveness Tested in a shear flow model, the heparin coating remained intact after 720 hours of continuous flow, simulating thirteen months of dialysis treatment. 21 Covidien s non-eluting heparin coating reduces the 2, 5, 14, likelihood of clot formation on the catheter surface. When compared to uncoated catheter Precision H Heparin Coated Dialysis

5 The Clinical Challenge: Colonisation The skin surrounding the catheter insertion site is one of the most common sources of microbes that colonise central venous catheters 22 Central venous catheters colonised by skin organisms may develop biofilms and ultimately catheter-related infections 22 The removal rate of catheters with exit-site infections is greater than 50%, and in instances of tunnel tract infections, the rate of removal is as high as 70% 23 Silver Ion Antimicrobial Sleeve Covidien s silver ion antimicrobial sleeve, situated between the cuff and the hub, is permanently bonded to the catheter surface to ensure durability. Antimicrobial silver ions work to reduce the colonisation of clinically relevant microbes in the subcutaneous tissue 24 Silver-polymer system delivers a controlled release of silver ions specifically designed for the dialysis catheter environment 24 Reducing microbial colonisation with antimicrobial technology. Technology in practice 1) Reduces microbial colonisation on catheter surface in the tunnel tract In vitro testing demonstrated a reduction of microbial colonisation by 99.2% % compared to catheter without sleeve. 24 In vivo testing resulted in a reduction of microbial colonisation by 99.7% % as compared to catheters without the sleeve. 24 2) Effective against a broad spectrum of micro-organisms Protects against Gram Positive and Negative Bacteria, Yeast and Fungi, including Staphylococcus aureus, Coagulase-negative Staphylococcus, Candida albicans and Escherichia coli as compared to catheters without the sleeve. 24 3) Proven durability The antimicrobial sleeve utilises a controlled release mechanism that delivers a sustained elution of silver ions below daily tolerable intake levels. 24 Covidien s silver ion sleeve minimises microbial 24, colonisation on the catheter surface. When compared to catheter without antimicrobial sleeve Precision SI Silver Ion Antimicrobial Dialysis

6 The Clinical Challenge: Clotting and Colonisation As many as 40% of catheter failures are attributed to venous thrombosis and fibrin sheath formation 17 Approximately 17%-33% of catheter removals are attributed to thrombosis 19 The skin surrounding the catheter insertion site is one of the most common sources of microbes that colonise central venous catheters 22 Central venous catheters colonised by skin organisms develop biofilms and ultimately catheter-related infections 22 Combining Technologies Covidien s ultimate catheter. The first chronic catheter to combine antimicrobial and antithrombogenic technologies to preserve access Dual protection against clotting and microbial colonisation on the catheter surface Combining innovative technologies. Providing Covidien s ultimate catheter. Technology in practice 1) Decreases likelihood of clot formation In vivo testing demonstrated an 82% reduction in thrombus accumulation. 2, 5, 14 In vitro testing showed a 60% reduction in platelet adhesion on the surface as compared to non-coated catheters. 14 2) Inhibits fibrin sheath propagation In vivo data demonstrated the non-eluting heparin coating has been shown to inhibit fibrin sheath propagation as compared to non-coated catheters. 4 3) Reduces microbial colonisation In vitro testing demonstrated a reduction of broad spectrum microbial colonisation on the catheter surface in the tunnel tract by 99.2% % compared to non-coated catheter. 24 Reduces microbial colonisation and reduces the likelihood 2, 5, 14, of clot formation on the catheter surface. When compared to uncoated catheter Precision HSI Heparin Coated and Silver Ion Antimicrobial Dialysis

7 The Clinical Challenge: Precise Placement Poor tip positioning accounts for 20% of early catheter removals 15 Post-insertion, early causes of low, catheter blood flow rates include catheter malposition and mechanical problems such as kinking 17 Successful catheter performance depends 16, 18 on accurate catheter tip positioning Precision RT Reverse-Tunnelled Covidien s unique self-flushing symmetric tip has a compact functional end versus other competitor tip designs. This affords the inserter greater real estate in the right atrium, allowing more flexibility in positioning the catheter tip within the mid-right atrium as recommended by NKF KDOQI Guidelines. 25 Facilitating precise tip placement and defined tunnel tract creation. Technology in practice 1 Precise tip placement Compact symmetric catheter tip can be placed precisely in the right atrium with increased flexibility for positioning. 25 Combined reverse-tunnelled technique and the Palindrome precision RT reverse-tunnelled catheter tip design increases the opportunity to maintain catheter tip location within the right atrium Defined tunnel trajectory Reverse-tunnel technique allows for precise placement of the catheter cuff in the tunnel tract after the tip has been placed. 25 Proper tunnel and arc creation demonstrate model insertion techniques essential for optimal catheter placement Easy click hub connection assembly Snap lock hub assembly facilitates easy attachment of the catheter to the back-end extensions, reduce catheter manipulation post-tip placement. 25 Covidien s reverse-tunnelled catheter with symmetric tip design and precision tip technology facilitates precise tip placement and increased tip visualisation. 25, When compared to uncoated catheter Precision RT Reverse-Tunnelled Dialysis

8 Product Selection and Ordering Components Precision Base, H, SI, and HSI s Repair Kits Colour Key Precision Base Precision H Heparin Coated Dialysis Precision SI Silver Ion Antimicrobial Precision HSI Heparin Coated and Silver Ion Antimicrobial Dialysis Precision RT Reverse Tunnelled Precision Precision with Tal VenaTrac Insertion Stylets Precision H Heparin Coated Precision SI Silver Ion Antimicrobial Sleeve Precision HSI Heparin Coated and Silver Ion Antimicrobial Sleeve Precision RT Reverse Tunnelled Product Codes Kits Insertion Length Overall Length P 19cm 36cm P 23cm 40cm P 28cm 45cm P 33cm 50cm P 44cm 61cm P 55cm 72cm P 19cm 36cm P 23cm 40cm P 28cm 45cm P 33cm 50cm CP 19cm 36cm CP 23cm 40cm CP 28cm 45cm CP 33cm 50cm CP 19cm 36cm CP 23cm 40cm CP 28cm 45cm CP 33cm 50cm CP 44cm 61cm CP 55cm 72cm CP 19cm 36cm CP 23cm 40cm CP 28cm 45cm CP 33cm 50cm P 19cm 39cm P 23cm 43cm P 28cm 48cm P 33cm 53cm P 44cm 64cm P 55cm 75cm Fr Symmetric Tip 1 VenaTrac Over-the-Wire Insertion Stylets 2 16Fr Valved Pull-Apart Safety Sheath 1 Bifurcated Tunneller 1 12Fr Tissue Dilator 1 14Fr Tissue Dilator 1 Injection Sealing Caps 2 Introducer Needle, 18g 1 J/Straight 0.038" Guidewire 1 Syringe, 12mL 1 #11 Scalpel 1 Telfa Island Dressings 2 4" x 4" Cotton Gauze Sponges 4 Components Precision RT Reverse Tunnelled 15Fr /valve adapter assembly 1 Hub/back-end assembly with coloured end cap 1 Hub snap connector 1 Tunneller 1 Additional tunneller cap 1 Syringe 1 4" x 4" Cotton Gauze Sponges 4 12Fr (4.0mm) dilator 1 14Fr (4.7mm) dilator 1 16Fr (5.3mm) valved pull-apart safety sheath/introducer 1 Telfa Island Dressings 1 Smooth Jawed Forceps 2 Sealing caps 2 External measuring kit (includes 18g (1.2mm) introducer needle, #11 scalpel, in (0.965 mm) J/straight guidewire) 1 Haemodialysis Repair Kit Components Product Codes Haemodialysis Repair Kit Arterial Repair Assembly 1 Venous Repair Assembly 1 Sealing Caps 2 Temporary Slide Clamps 2 Drape 1 Disposable Scissors 1 Measurement Guide 1 Priming Volume Label Sheet 1 Precision RT Reverse-Tunnelled Kit Code Length cm cm cm cm cm Corresponding Precision RT Reverse-Tunnelled Repair Kit cm Note: Ensure that the catheter repair kit corresponds to the same implant length as the indwelling catheter so that the pre-calculated priming volumes located on the repair hub/back-end assembly match. Components Haemodialysis Repair Kit Hub/back-end assembly 1 Hub snap connector 1 Smooth jawed forceps 2 Sealing caps 2 Drape 1 Clinical References 1. Covidien Internal Testing, Nemo Design Validation Protocol MS-11, December 13, Covidien Internal Testing, Design Verification Testing Report for Nemo, MS-11 February 29, Covidien Internal Testing, Palindrome TM and Maxid TM Design Verification Testing Report for Carbothane (Polyether-Polycarbonate-Polyurethane) Replacement MS-10, March 3, Covidien Internal Testing, Nemo Design Validation Master Plan MS-12, January 10, Covidien Internal Testing, Design Verification Testing Report for Nemo MS-12, June 27, Covidien Internal Testing, Ruby, Emerald and SapphiRE Design Verification Testing Protocol MS-10, September 14, Kakkos, SK et al. Effectiveness of a New Tunnelled in Preventing Malfunction: A Comparative Study. J Vasc Interventional Rad 19(7): , Report on PALINDROME TM Tip CFD Analysis. Prepared by Ravishankar L N. L&T Integrated Engineering Services, March 1, Covidien Internal Testing, Test Protocol, Covidien NEMO Dialysis Recirculation BDCTR-CWO-12004, February 9, Tal, MG. Comparison of Recirculation Percentage of the precision and Standard Haemodialysis s in a Swine Model. J Vasc Interventional Rad 16(9): , Oliver, MJ et al. Randomised Study of Temporary Haemodialysis s. International Journal of Artif Organs 25(1): 40-44, Senecal, L et al. Blood Flow and Recirculation Rates in Tunnelled Haemodialysis s. Amer Soc Artificial Internal Organs 50: 94-97, Mojibian Hamid R., et al. VenaTrac TM device for over-the-wire placement of chronic dialysis catheters. J of Vascular Access, Covidien Internal Testing, Thromboresistant Coating Technology Feasibility Study MAN-03, March 28, Wong, JK et al. Analysis of Early Failure of Tunnelled Haemodialysis s. AJR 179: , Vesely, TM. Central Venous Tip Position: A Continuing Controversy. JVIR 14: , Trerotola, SO. Haemodialysis Placement and Management. Radiology 215: , Ross, JR. Optimising Tip Positioning. Endovascular Today July/Aug 2003, Archives / Dinwiddie, LC. Managing Dysfunction for Better Patient Outcomes: A Team Approach. Nephrol Nurs J 31(6): , Twardowski, Z. The Clotted Central Vein for Haemodialysis. Nephrol Dial Transplant 13: , Covidien Internal Testing, Project Albacore - Chronic Dialysis Verification Testing (Coating Performance) MAN-05, April 25, Raad, I et al. Ultrastructural Analysis of Indwelling Vascular s: A Quantitative Relationship between Luminar Colonisation and Duration of Placement. J of Infectious Dis 168: , Develter, W et al. Survival and Complications of Indwelling Venous s for Permanent Use in Haemodialysis Patients. Artif Organs 29(5): , Covidien Internal Testing, Project Mackerel - Chronic Dialysis Verification Testing Safety Testing Man-05, March 14, NKF-KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations Updates Clinical Practice Guideline for Vascular Access. Guideline 2. Selection and Placement of Haemodialysis Access (Rationale: s and Port Systems [CPG 2.4]). Does not include VenaTrac TM Ruler 1

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