BALLOON 1. PTA Balloon Catheter 1.1 ALLUNGA 1.1.1. Description 1.1.2. Technical Data 1.1.3. Materials used 1.1.4. Compliance Chart 1.1.5. Graph 1.1.6. Side by Side Comparison amg International GmbH Löhnfeld 26 D-21423 Winsen Germany Tel +49 4171 6905 57-0 Email info@thestentcompany.com www.thestentcompany.com PM APC_00 March 2014
1.1.1. Description
1.1.1. Description The ALLUNGA PTA Balloon Catheter is a high performance balloon catheter for peripheral indication. The device features an ultra-low profile, semi-compliant balloon combined with a low profile tip. The ALLUNGA PTA Balloon Catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. The working lengths of the balloon catheter (usable catheter length) vary and are selected based on patient requirements for PTA. The radiopaque marker(s) are placed beneath the working area (usable balloon length) of the balloon and are visible when used in conjunction with fluoroscopy and aid in the placement of the balloon. The effective length could increase by 1 cm in a fully hydrated state. Please check the package label for all individual product sizes. Each balloon inflates to the stated diameter and length at a specific pressure. The maximum rated burst pressure is different for each size - please check the package label for the rated burst pressure. It is important that the balloon not be inflated beyond the rated burst pressure. The proximal portion of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock port for the guidewire lumen. The devices can be supplied with and without Hydrophilic coating so be sure to review your device selection by observing the box and package label. The Hydrophilic coating when applied is applied proximally of the balloon for a length of 40 cm. The PTA Balloon Catheter is a non-pyrogenic device. The ALLUNGA PTA Balloon-Catheter is for the purpose of the medical device law a temporary applicable surgical invasive product especially intended for diagnosis, control or correction of a heart disease (vessel occlusion) or central circulation system being exposed to these areas of the human body (class IIa, rule 7 acc. to Annex IX of directive 93/42ECC). Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 1-15
Indication The ALLUNGA PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Contraindication The ALLUNGA PTA Balloon Catheter is contraindicated for use in coronary arteries or the neurovasculature, or when unable to cross the target lesion with a guidewire. Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 2-15
1.1.2. Functional and Technical Data 1.1.3. Materials used 1.1.4. Compliance Chart 1.1.5 Graph
1.1.2. Technical Data Parameter Value VERSION: 0.014 0.018 0.035 Design Distal section Nominal Pressure Rated Burst Pressure Balloon characteristic Balloon folding Direction fo Balloon folding, seen from the tip X ray balloon marker Recommended guide wire Recommended introducer sheath [F/mm] Maximum Deflation Time (water, 37 C) Refold up to RPB Usable catheter lengths (Tip - kink protection) UBL Usable Balloon Length Nominal Balloon Diameter Length Tapered Tip (LTT) Ø 1.25 to Ø 5.00mm: 9 bar Ø 1.25 to Ø 5.00mm 18 bar Over-the-wire catheter two coaxial lumen Ø 2.00 to Ø 7.00mm: 9 bar Ø 2.00 to Ø 7.00mm 18 bar semi-compliant 3 folds to left (anti-clockwise) Ø 3.00 to Ø 12.00mm: 7 bar Ø 3.00mm: 13 bar Ø 3.50 to 12.00mm: 10 bar one marker at each balloon end, proximal and distal 0.014 (0.36mm) 0.018 (0.46mm) 0.035 (0.89mm) 4 F/1.35mm up to Ø 4.50mm 5 F/1.67mm for Ø 5.00 mm Ø 1.25 to Ø 5.00mm 70 sec Ø 1.25 to Ø 5.00mm 3 folds 1200 +25/-15mm 1500 +25/-15mm 1600 +25/-15mm 10 / 15 / 20 / 30 / 40 / 60 / 80 / 100 / 120 / 140 / 150 / 170 / 200 / 220 / 250 / 280 mm 1.25 / 1.50 / 2.00 / 2.50 / 3.00 / 3.50 / 4.00 / 4.50 / 5.00 mm 4 F/1.35mm up to Ø 4.50mm 5 F/1.67mm for Ø 5.00 to Ø 6.00mm 6 F/2.00mm for Ø 7.00mm Ø 2.00 to Ø 7.00mm 70 sec Ø 2.00 to Ø 7.00mm 3 folds 800 +25/-15mm 1350 +25/-15mm 10 / 15 / 20 / 30 / 40 / 60 / 80 / 100 / 120 / 150 / 200 / 220 / 280 mm 2.00 / 2.50 / 3.00 / 3.50 / 4.00 / 4.50 / 5.00 / 5.50 / 6.00 / 6.50 / 7.00 mm 5 F/1.67mm upto Ø 3.50 mm 6 F/2.00mm for Ø 4.00 to Ø 9.00 mm 7 F/2.33mm for Ø 10.00 mm 9F/3.00mm for Ø 12.00 mm Ø 3.00 to Ø 12.00mm 0.06ml/sec Ø 3.00 to Ø 12.00mm 3 folds 450 ± 10mm 800 +25/-15mm 1200 +25/-15mm 1500 +25/-15mm 10 / 15 / 20 / 30 / 40 / 60 / 80 / 100 / 120 / 150 / 200 / 220 / 280 mm 3.00 / 3.50 / 4.00 / 4.50 / 5.00 / 5.50 / 6.00 / 7.00 / 8.00 / 9.00 / 10.00 / 12.00 mm 2.50 ± 0.5 mm 2.00 ± 0.5 mm 2.00 ± 0.5 mm Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 3-15
Parameter Value VERSION: 0.014 0.018 0.035 Entry profile 0.45 ± 0.1mm 0.50 ± 0.1mm 0.95 ± 0.15mm Shaft diameter 1.067 ± 0.025mm 1.270 ± 0.025mm 1.750 ± 0.025mm Minimum guide wire lumen 0.406 mm, sliding without rubbing at 18 bars inflation pressure 0.495 mm, sliding without rubbing at 18 bars inflation pressure 0.975 mm, sliding without rubbing at 18 bars inflation pressure Coating length (if applicable) 400 ± 15mm Coating hydrophilic Coating area Sterilization Shelf life Use Ethylene oxide (EO) sterilization Re-sterilization is possible 1 year (starting from sterilization date) For single use only 1.1.3. Materials used Item Specification VERSION: 0.014 0.018 0.035 Balloon Nylon 12 Pebax 7233 Co Extruder Inner Lumen Tubing Outer Lumen Tubing Marker Bands Pebax 7233 / Plexar PX380 / PE-LM6007 Pebax 7233 / Plexar PX380 / PE-LM600-700 Pebax 7233 SA01 90% Platinum / 10% Iridium Y - Luer lock Polycarbonate (PC), Makrolon 2458 Shrink tubing Polyolefin n/a Inner Lumen Tubing Pebax 7233 SA01 n/a Strain Relief Pebax 4033 SA01 Protection wire Stainless Steel WKN 1.4301 Balloon Retainer Catheter Dispenser HDPE PTFE Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 4-15
1.1.4. Compliance Chart Compliance Table ALLUNGA PTA Balloon Catheter 0.014 Pressure [bar] Balloon Diameter [mm] 1.25 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5 bar 1.21 1.46 1.94 2.43 2.92 3.40 3.88 4.36 4.84 6 bar 1.22 1.47 1.96 2.45 2.94 3.43 3.91 4.40 4.88 7 bar 1.23 1.48 1.97 2.47 2.96 3.45 3.94 4.43 4.92 8 bar 1.24 1.49 1.99 2.48 2.98 3.48 3.97 4.47 4.96 9 bar (NP) 1.25 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 10 bar 1.26 1.51 2.02 2.52 3.02 3.53 4.03 4.54 5.04 11 bar 1.27 1.52 2.03 2.54 3.04 3.55 4.06 4.57 5.08 12 bar 1.28 1.53 2.05 2.55 3.06 3.58 4.09 4.61 5.12 13 bar 1.29 1.54 2.06 2.57 3.08 3.60 4.12 4.64 5.16 14 bar 1.30 1.55 2.08 2.59 3.10 3.63 4.015 4.68 5.20 15 bar 1.31 1.56 2.09 2.61 3.12 3.65 4.18 4.71 5.24 16 bar 1.32 1.57 2.11 2.62 3.14 3.68 4.21 4.75 5.28 17 bar 1.33 1.58 2.12 2.64 3.16 3.70 4.24 4.78 5.32 18 bar (RBP) 1.34 1.59 2.14 2.66 3.18 3.73 4.27 4.82 5.36 19 bar 1.35 1.60 2.15 2.68 3.20 3.75 4.30 4.85 5.40 20 bar 1.36 1.61 2.17 2.69 3.22 3.78 4.33 4.89 5.44 21 bar 1.37 1.62 2.18 2.71 3.24 3.80 4.36 4.92 5.48 22 bar 1.38 1.63 2.20 2.73 3.26 3.83 4.39 4.96 5.52 23 bar 1.39 1.64 2.21 2.75 3.28 3.85 4.42 4.99 5.56 24 bar 1.40 1.65 2.23 2.76 3.30 3.88 4.45 5.03 5.60 25 bar 1.41 1.66 2.24 2.78 3.32 3.90 4.48 5.06 5.64 26 bar 1.42 1.67 2.26 2.80 3.34 3.93 4.51 5.10 5.68 27 bar 1.43 1.68 2.27 2.82 3.36 3.95 4.54 5.13 5.72 28 bar 1.44 1.69 2.29 2.83 3.38 3.98 4.57 5.17 5.76 29 bar 1.45 1.70 2.30 2.85 3.40 4.00 4.60 5.20 5.80 30 bar 1.46 1.71 2.32 2.87 3.42 4.03 4.63 5.24 5.84 Att. 1 Compliance of PTA Balloon (± 5% Tolerance) Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 5-15
Compliance Table ALLUNGA PTA Balloon Catheter 0.018 Pressure Balloon Diameter [mm] [bar] 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00 5 bar 1.93 2.40 2.88 3.36 3.84 4.34 4.84 5.32 5.80 6.26 6.76 6 bar 1.95 2.43 2.91 3.40 3.88 4.38 4.88 5.37 5.85 6.32 6.82 7 bar 1.97 2.45 2.94 3.43 3.92 4.42 4.92 5.41 5.90 6.38 6.88 8 bar 1.98 2.48 2.97 3.47 3.96 4.46 4.96 5.46 5.95 6.44 6.94 9 bar (NP) 2.00 2.50 3.00 3.50 4.00 4.50 5.00 5.50 6.00 6.50 7.00 10 bar 2.02 2.53 3.03 3.54 4.04 4.54 5.04 5.55 5.05 6.56 7.06 11 bar 2.03 2.55 3.06 3.57 4.08 4.58 5.08 5.59 5.10 6.62 7.12 12 bar 2.05 2.58 3.09 3.61 4.12 4.62 5.12 5.64 5.15 6.68 7.18 13 bar 2.07 2.60 3.12 3.64 4.16 4.66 5.16 5.68 5.20 6.74 7.24 14 bar 2.09 2.63 3.15 3.68 4.20 4.70 5.20 5.73 5.25 6.80 7.30 15 bar 2.10 2.65 3.18 3.71 4.24 4.71 5.24 5.77 5.30 6.86 7.36 16 bar 2.12 2.68 3.21 3.75 4.28 4.78 5.28 5.82 5.35 6.92 7.42 17 bar 2.14 2.70 3.24 3.78 4.32 4.82 5.32 5.86 5.40 6.98 7.48 18 bar (RBP) 2.15 2.73 3.27 3.82 4.36 4.86 5.36 5.91 5.45 7.04 7.54 19 bar 2.17 2.75 3.30 3.85 4.40 4.90 5.40 5.95 5.50 7.10 7.60 20 bar 2.19 2.78 3.33 3.89 4.44 4.94 5.44 6.00 5.55 7.16 7.66 21 bar 2.20 2.80 3.36 3.92 4.48 4.98 5.48 6.04 5.60 7.22 7.72 22 bar 2.22 2.83 3.39 3.96 4.52 5.02 5.52 6.09 5.65 7.28 7.78 23 bar 2.24 2.85 3.42 3.99 4.56 5.06 5.56 6.13 5.70 7.34 7.84 24 bar 2.26 2.88 3.45 4.03 4.60 5.10 5.60 6.18 5.75 7.40 7.90 25 bar 2.27 2.90 3.48 1.06 4.64 5.14 5.64 6.22 5.80 7.46 7.96 26 bar 2.29 2.93 3.51 4.10 4.68 5.18 5.68 6.27 5.85 7.52 8.02 27 bar 2.31 2.95 3.54 4.13 4.72 5.22 5.72 6.31 5.90 7.58 8.08 28 bar 2.32 2.98 3.57 4.17 4.76 5.26 5.76 6.36 5.95 7.64 8.14 29 bar 2.34 3.00 3.60 4.20 4.80 5.30 5.80 6.40 6.00 7.70 8.20 30 bar 2.36 3.03 3.63 4.24 4.84 5.34 5.84 6.45 6.05 7.76 8.26 Att. 2 Compliance of PTA Balloon (± 5% Tolerance) Compliance Table ALLUNGA PTA Balloon Catheter 0.035 Pressure Balloon Diameter [mm] [bar] 3.00 3.50 4.00 4.50 5.00 5.50 6.00 7.00 8.00 9.00 10.00 12.00 5 bar 2.94 3.42 3.84 4.36 4.84 5.32 5.80 6.80 7.76 8.80 9.64 11.54 6 bar 2.97 3.46 3.91 4.43 4.92 5.41 5.90 6.90 7.88 8.90 9.82 11.77 7 bar (NP) 3.00 3.50 4.00 4.50 5.00 5.50 6.00 7.00 8.00 9.00 10.00 12.00 8 bar 3.03 3.54 4.06 4.57 5.08 5.59 6.10 7.10 8.12 9.10 10.18 12.23 9 bar 3.06 3.58 4.12 4.64 5.16 5.68 6.20 7.20 8.24 9.20 10.36 12.46 10 bar (RBP) 3.09 3.62 4.18 4.71 5.24 5.77 6.30 7.30 8.36 9.30 10.54 12.69 11 bar 3.12 3.66 4.24 4.78 5.32 5.86 6.40 7.40 8.48 9.40 10.72 12.92 12 bar 3.15 3.70 4.30 4.85 5.40 5.95 6.50 7.50 8.60 9.50 10.90 13.15 13 bar (RBP) 3.18 3.74 4.36 4.92 5.48 6.04 6.60 7.60 8.72 9.60 11.08 13.38 14 bar 3.21 3.78 4.42 4.99 5.56 6.13 6.70 7.70 8.84 9.70 11.26 13.61 15 bar 3.24 3.82 4.48 5.06 5.64 6.22 6.80 7.80 8.96 9.80 11.44 13.84 16 bar 3.27 3.86 4.54 5.13 5.72 6.31 6.90 7.90 9.08 9.90 11.62 14.07 17 bar 3.30 3.90 4.60 5.20 5.80 6.40 7.00 8.00 9.20 10.00 11.80 14.30 Att. 3 Compliance of PTA Balloon (± 10% Tolerance) Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 6-15
1.1.5. Graph Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 7-15
1.1.6. Side by Side Comparison
1.1.6. Side by Side Comparison Graph 1.1.6.1 Tip Entrance Diameter Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 8-15
Graph 1.1.6.2-4, Mean Trackability Force [mn] Less force desired 1.1.6.2 1.1.6.3 1.1.6.4 Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 9-15
Graph 1.1.6.5-7, Pushability (%) Indicates the efficiency of force transmission throughout the total axial length, prox.-dist. end 1.1.6.5 1.1.6.6 1.1.6.7 Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 10-15
Graph 1.1.6.8-10; Deflation Time (sec) 1.1.6.8 1.1.6.9 1.1.6.10 Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 11-15
Graph Chart 1.1.6.11; Compliance Competitor ALLUNGA.014 Cordis Sleek 2 x 22omm Medtronic Amphirion 1,5 x 20mm EV3 NanoCross 3x20mm NP RBP NP RBP 5 15 9 18* 7 14 9 18* 10 14 9 18* Abbott Asmada 4 x 20mm 8 14 9 18* High Rate Burst Pressure over the entire size range *the RBP is currently in the evaluation phase, tested is up to now 18bar RBP, but the data shows that 22bar might be possible in the future Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 12-15
Graph Chart 1.1.6.12; Compliance Cordis Savvy Long 4x150mm Cordis Savvy 5x20mm ABBOTT FOX SV 4x20mm ABBOTT FOC SV 3x20mm ABBOTT FOX SV 3x100mm EV3 PowerCross 5x20mm EV3 PowerCross 4x150mm BostonSc Sterling 4x150mm Competitor ALLUNGA.018 NP RBP NP RBP 6 15 9 18* 6 10 9 18* 8 20 9 18* 8 22 9 18* 8 20 9 18* 8 14 9 18* 8 14 9 18* 6 14 9 18* High Rate Burst Pressure over the entire size range *the RBP is currently in the evaluation phase, tested is up to now 18bar RBP, but the data shows that 22bar might be possible in the future Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 13-15
Graph Chart 1.1.6.13; Compliance Q2 ALLUNGA Competitor.035 NP RBP NP RBP Cordis Powerflex P3 9x80mm Medtronic Amphirion 10x20mm V3 EverCross 3x20mm Abbott FoxCross 3x20mm 10 14 7 10* 6 11 7 10* 10 18 7 13* 10 18 7 13* Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 14-15
1.1.7. Conclusion
1.1.7. Conclusion Lowest entry profile in the industry with the addition of a beveled tip to allow for access to the most difficult lesions Maximum flexibility for easy navigation to reach the most distal lesions Increased pushability for a significant amount of applied force transition from the hub to the tip Fast inflation and deflation times to maximize efficiency during treatment and reducing the procedure time compared to other industry participants Reduced radiation exposure for clinician, team, and patient due to decreased time for balloon operation High rate burst pressure to optimize working range and to increase the safety level for the patients Description: 140314aek ALLUNGA PTA Balloon Catheter_Description Page: 15-15