XEMEX IABP Balloon Plus

Transcription

1 XEMEX IABP Balloon Plus Ordering information Balloon Volume Catheter O.D. Balloon Length Balloon Diameter Recommended Patient Height BPGL57 (E) 5mL 18mm 15cm 11 BPGL7 (E) cm 11 5 BPGL57 (E) 165cm 5 5 BPGL8 (E) 155cm 5 1 BPGL58 (E) 1mm 15.1mm cm BPGL8 (E) 15.1mm 165cm 5 5 BPGL58-SH (E)* 16mm 15cm 9 BPGL8-SH(E)* 18mm 16cm 5 *Short Balloon Type **Refer to the figure only as a guide. Please select product by confirming balloon length and diameter. Manufactured by: 1-6- Marunouchi, Chiyoda-ku, Tokyo 1, Japan TEL: FAX: XEMEX is the brand by ZEON MEDICAL INC. Copyright 17 ZEON MEDICAL INC. All rights reserved. Ver. July 17 (E)CX- 717(IM5) Agent: **

2 Techn nology from JA APAN Eterna al pursu uit of safety and crea atiivity Measurement of Aorta and analysis of IABP balloon sizes Development of New Concept Balloon Each size below was measured via images of CT (Figure 1) No. of patients: 1 patients on whom contrast-enhanced CT was performed XEMEX IABP Balloon Plus 8F Short Balloon Reference and citation: Use of 8F Short Balloons at Our Facility by Kazuya Hirata, Department of ME, Hokkaido Social Insurance Hospital, Japan Three keys for patient-oriented catheter Measured Items 1. Distance between left subclavian artery and aorta below renal artery. Minor diameter of descending aorta. Minor diameter of subphrenic aorta. Minor diameter of aorta below renal artery XEMEX product development in close cooperation with medical sites IABP Augmentation Efficacy Catheter Migration -Balloon diameter is increased by mm for better augmentation -Nylon catheter shaft performs high durability The experiment proved that XEMEX Short IABP balloon catheter was remarkable in augmentation effect compared to Normal IABP. The experiment proved that XEMEX Short IABP is superior to those of competitors as well as XEMEX conventional balloon. (mmhg msec) Figure : Results of measurement 1. XEMEX 8F Short Figure 1 : Sites of measurement Measured tip positioning after 1-hour driving in the mock circuit n=1 16. In the analysis of balloon diameter, the diameter of the aortic artery was larger than the balloon diameter of the Shor t IABP at the site of the positioned IABP catheter. However, since the descending aorta begins to follow a tortuous course nearby the subphrenic region and there is a risk of the balloon contacting the vessel wall at the tortuous points, the augmentation level should be set properly by watching the balloon pressure patterns in order not to expose the vascular wall to excessive stress. Feature Measurement of augmentation efficacy, short balloon and normal balloon The result shows that the aortic vessel tends to become smaller below the renal ar ter y and appears calcification and intimal hypertrophy in approximately % of the patients. Considering IAB balloon length and balloon diameter, when 8F Normal IABP catheter was used in these patients, the catheter was positioned nearby the area below the renal artery in some cases, which raises the risk of balloon rupture and other complications. To ensure safety in this case, use of 8F Short IABP catheter seemed to be superior. (Figure ) 8F Short Balloon Prevent renal arterial occlusion High augmentation performance Reduce balloon leak risk Company A 8F male female total Company B 8F 1.5 XEMEX 8F Normal Number of patients: 6 1 Mean age (years) Mean height (cm) Distance from left subclavicular artery to aorta below renal artery Minor diameter of descending aorta Minor diameter of subphrenic aorta Minor diameter of aorta below renal artery Vessel mm Vessel 5mm Vessel mm Vessel 5mm - * Short balloon is only for test trial and not for sale *Comparison of Length ( IABP) Balloon length is reduced by 5% of conventional balloon catheter Better pushability, better trackability and less risk of renal arterial occlusion Data logger Pressure transducer IAB Short Thermo stat (7 ) PC VAD Cushion tank for pressure adjustment. lumen for blood pressure measurement Calcification or tunica intima thickening seen in about % of cases Normal IABP Short IABP Mock circuit for the experiment Normal Pseudo Blood : 5% glycerin solution, warmed to 7 (viscosity cps) Blood Pressure : 1/5 mmhg, heart rate 1bpm Console : XEMEX IABP Console 98 Assist ratio : 1: Data collected and analyzed by Hokkaido Social Insurance Hospital, Japan

3 Techn nology from JA APAN Eterna al pursu uit of safety and crea atiivity Measurement of Aorta and analysis of IABP balloon sizes Development of New Concept Balloon Each size below was measured via images of CT (Figure 1) No. of patients: 1 patients on whom contrast-enhanced CT was performed XEMEX IABP Balloon Plus 8F Short Balloon Reference and citation: Use of 8F Short Balloons at Our Facility by Kazuya Hirata, Department of ME, Hokkaido Social Insurance Hospital, Japan Three keys for patient-oriented catheter Measured Items 1. Distance between left subclavian artery and aorta below renal artery. Minor diameter of descending aorta. Minor diameter of subphrenic aorta. Minor diameter of aorta below renal artery XEMEX product development in close cooperation with medical sites IABP Augmentation Efficacy Catheter Migration -Balloon diameter is increased by mm for better augmentation -Nylon catheter shaft performs high durability The experiment proved that XEMEX Short IABP balloon catheter was remarkable in augmentation effect compared to Normal IABP. The experiment proved that XEMEX Short IABP is superior to those of competitors as well as XEMEX conventional balloon. (mmhg msec) Figure : Results of measurement 1. XEMEX 8F Short Figure 1 : Sites of measurement Measured tip positioning after 1-hour driving in the mock circuit n=1 16. In the analysis of balloon diameter, the diameter of the aortic artery was larger than the balloon diameter of the Shor t IABP at the site of the positioned IABP catheter. However, since the descending aorta begins to follow a tortuous course nearby the subphrenic region and there is a risk of the balloon contacting the vessel wall at the tortuous points, the augmentation level should be set properly by watching the balloon pressure patterns in order not to expose the vascular wall to excessive stress. Feature Measurement of augmentation efficacy, short balloon and normal balloon The result shows that the aortic vessel tends to become smaller below the renal ar ter y and appears calcification and intimal hypertrophy in approximately % of the patients. Considering IAB balloon length and balloon diameter, when 8F Normal IABP catheter was used in these patients, the catheter was positioned nearby the area below the renal artery in some cases, which raises the risk of balloon rupture and other complications. To ensure safety in this case, use of 8F Short IABP catheter seemed to be superior. (Figure ) 8F Short Balloon Prevent renal arterial occlusion High augmentation performance Reduce balloon leak risk Company A 8F male female total Company B 8F 1.5 XEMEX 8F Normal Number of patients: 6 1 Mean age (years) Mean height (cm) Distance from left subclavicular artery to aorta below renal artery Minor diameter of descending aorta Minor diameter of subphrenic aorta Minor diameter of aorta below renal artery Vessel mm Vessel 5mm Vessel mm Vessel 5mm - * Short balloon is only for test trial and not for sale *Comparison of Length ( IABP) Balloon length is reduced by 5% of conventional balloon catheter Better pushability, better trackability and less risk of renal arterial occlusion Data logger Pressure transducer IAB Short Thermo stat (7 ) PC VAD Cushion tank for pressure adjustment. lumen for blood pressure measurement Calcification or tunica intima thickening seen in about % of cases Normal IABP Short IABP Mock circuit for the experiment Normal Pseudo Blood : 5% glycerin solution, warmed to 7 (viscosity cps) Blood Pressure : 1/5 mmhg, heart rate 1bpm Console : XEMEX IABP Console 98 Assist ratio : 1: Data collected and analyzed by Hokkaido Social Insurance Hospital, Japan

4 Techn nology from JA APAN Eterna al pursu uit of safety and crea atiivity Advantage Technology 1. Inner Stopper 1. High Level Balloon and Catheter Positioning Stability Competitor Keeps proper position of after catheter placement Strengthened adhesion of inner and outer tubes for stable pumping (patent pending) Integrated double lumen structure for superior response performance and durability of the catheter Area from celiac artery to renal arteries 8F Short Balloon Migrated catheter position by blood heat softening. High Durability of Catheter Shaft Superior stability of Nylon catheter shaft Prevents catheter from blood heat softening and damage of vessel walls Stiffer shaft provides super trackability to catherter 1. Stiff nylon catheter shaft. Three-level-diameter shaft structure Measurement of balloon position migration after 1-hour driving in the mock vessel Large helium gas lumen provides better response performance with small size catheters Kink-resistant performance improved by reliable inner and outer shaft anchoring Helium gas Lumen. Three-Level-Diameter -1 - New XEMEX 8F Company A 8F - 5. Sheath Introducer -1 New XEMEX 7F Sheath tip insertion resistance. Pumping Response Performance (Newton) 8 7 XEMEX 7F XEMEX 8F 6 5 Pumping response performance is ensured by: Tapered structure toward proximal of outer shaft provides catheter shaft durability Succeeded in higher response performance by enlargement of helium gas lumen of outer shaft outside of the body Less gap between sheath and dilator Feature. Integrated Double Lumen Structure High Balloon position stability: 1. Double lumen structure with large helium gas lumen. Three-level-diameter catheter shaft. Inner stopper anchoring Company C 8F Measurement of total inflation and deflation time (msec) (msec) 5 ZEON MEDICAL s processing technology realized: Smooth transition of diameter gap Less insertion resistance Increased intensity Prevention of distortion or deformation Excellence trackability of dilator tip to GW Downsized dilator tip has increased: Tip flexibility and trackability to the guide wire Prevention of damage to the vessel wall 6. Soft tip of catheter prevents unintentional vessel damage New XEMEX 7F New XEMEX 8F Company A 8F Sophisticated taper shape and soft material for catheter tip 5

5 Techn nology from JA APAN Eterna al pursu uit of safety and crea atiivity Advantage Technology 1. Inner Stopper 1. High Level Balloon and Catheter Positioning Stability Competitor Keeps proper position of after catheter placement Strengthened adhesion of inner and outer tubes for stable pumping (patent pending) Integrated double lumen structure for superior response performance and durability of the catheter Area from celiac artery to renal arteries 8F Short Balloon Migrated catheter position by blood heat softening. High Durability of Catheter Shaft Superior stability of Nylon catheter shaft Prevents catheter from blood heat softening and damage of vessel walls Stiffer shaft provides super trackability to catherter 1. Stiff nylon catheter shaft. Three-level-diameter shaft structure Measurement of balloon position migration after 1-hour driving in the mock vessel Large helium gas lumen provides better response performance with small size catheters Kink-resistant performance improved by reliable inner and outer shaft anchoring Helium gas Lumen. Three-Level-Diameter -1 - New XEMEX 8F Company A 8F - 5. Sheath Introducer -1 New XEMEX 7F Sheath tip insertion resistance. Pumping Response Performance (Newton) 8 7 XEMEX 7F XEMEX 8F 6 5 Pumping response performance is ensured by: Tapered structure toward proximal of outer shaft provides catheter shaft durability Succeeded in higher response performance by enlargement of helium gas lumen of outer shaft outside of the body Less gap between sheath and dilator Feature. Integrated Double Lumen Structure High Balloon position stability: 1. Double lumen structure with large helium gas lumen. Three-level-diameter catheter shaft. Inner stopper anchoring Company C 8F Measurement of total inflation and deflation time (msec) (msec) 5 ZEON MEDICAL s processing technology realized: Smooth transition of diameter gap Less insertion resistance Increased intensity Prevention of distortion or deformation Excellence trackability of dilator tip to GW Downsized dilator tip has increased: Tip flexibility and trackability to the guide wire Prevention of damage to the vessel wall 6. Soft tip of catheter prevents unintentional vessel damage New XEMEX 7F New XEMEX 8F Company A 8F Sophisticated taper shape and soft material for catheter tip 5

6 Technology from JAPAN Eternal pursuit of safety and creativity XEMEX IABP Balloon Plus Specification (insertion with sheath / sheath less ) Catheter Tray Balloon volume Catheter outer diameter Catheter type Inner diameter Catheter active length Balloon length Balloon diameter Catheter material Balloon material BPGL57 (E) BPGL7 (E) BPGL57 (E) 5mL.mm (7.F).71mm (.8inch).5mm (.inch).mm (7.F).71mm (.8inch).5mm (.inch).mm (7.F).71mm (.8inch).5mm (.inch) 651mm 681mm 71mm 18mm Outer tube: Nylon (antithrombogenic polyurethane coating) Inner tube: Special treated resin High-strength antithrombogenic polyurethane coating 5mL syringe, One-way valve for decompression Introducer Tray Sheath type Sheath active length Sheath inner diameter Standard type with hemostasis valve 17.5cm.mm J tip guide wire for balloon catheter insertion.5mm (. inch) X 15cm J tip guide wire for sheath introducer.88mm (.5 inch) X 8cm 18G Needle, Adapter for other manufacturer's driving consoles, Dilator (6F X 16.5cm), Blood pressure monitoring lines, -way stopcock Balloon volume Catheter outer diameter Catheter type Inner diameter Catheter active length Balloon length Balloon diameter Catheter material Balloon material Sheath type Sheath active length Sheath inner diameter Catheter Tray BPGL8 (E) BPGL58 (E) BPGL8 (E).66mm (8.F).88mm (.5inch).79mm (.1inch).66mm (8.F).88mm (.5inch).79mm (.1inch) 695mm 7mm 75mm 1mm 15.1mm 15.1mm Outer tube: Nylon (antithrombogenic polyurethane coating) Inner tube: Special treated resin High-strength antithrombogenic polyurethane coating 5mL syringe, One-way valve for decompression.66mm (8.F).88mm (.5inch).79mm (.1inch) Introducer Tray Standard type with hemostasis valve 17.5cm.7mm J tip guide wire for balloon catheter insertion.79mm (.1inch) X 15cm J tip guide wire for sheath introducer.88mm (.5 inch) X 8cm 18G Needle, Adapter for other manufacturer's driving consoles, Dilator (7F X 16.5cm), Blood pressure monitoring lines, -way stopcock 6

7 16mm/18mm Balloon volume Catheter outer diameter Catheter type Inner diameter Catheter active length Balloon length Balloon diameter Catheter material Balloon material Sheath type Sheath active length Sheath inner diameter Catheter Tray BPGL58-SH (E).66mm (8.F).88mm (.5 inch).79mm (.1 inch) 68mm 16mm Catheter Tray BPGL8-SH (E).66mm (8.F).88mm (.5 inch).79mm (.1 inch) 75mm 18mm Outer tube: Nylon(antithrombogenic polyurethane coating) Inner tube: Special treated resin High-strength antithrombogenic polyurethane coating 5mL syringe, One-way valve for decompression Introducer Tray Standard type with hemostasis valve 17.5cm.7mm J tip guide wire for balloon catheter insertion.79mm (.1inch) X 15cm J tip guide wire for sheath introducer.88mm (.5inch) X 8cm 18G Needle, Adapter for other manufacturer's driving consoles, Dilator (7F X 16.5cm), Blood pressure monitoring lines, -way stopcock Introducer Tray 8F Short Balloon Feature Driving Tube For MAQUET Console For TeleFlex Console Caution Please make sure to use catheter and introducer set packed in the same box. Please make sure to read the attached IFU when using the product. 7

8 XEMEX IABP Balloon Plus Ordering information Balloon Volume Catheter O.D. Balloon Length Balloon Diameter Recommended Patient Height BPGL57 (E) 5mL 18mm 15cm 11 BPGL7 (E) cm 11 5 BPGL57 (E) 165cm 5 5 BPGL8 (E) 155cm 5 1 BPGL58 (E) 1mm 15.1mm cm BPGL8 (E) 15.1mm 165cm 5 5 BPGL58-SH (E)* 16mm 15cm 9 BPGL8-SH(E)* 18mm 16cm 5 *Short Balloon Type **Refer to the figure only as a guide. Please select product by confirming balloon length and diameter. Manufactured by: 1-6- Marunouchi, Chiyoda-ku, Tokyo 1, Japan TEL: FAX: XEMEX is the brand by ZEON MEDICAL INC. Copyright 17 ZEON MEDICAL INC. All rights reserved. Ver. July 17 (E)CX- 717(IM5) Agent: **