Family of Diagnostic and Therapeutic Catheters

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Family of Diagnostic and Therapeutic Catheters Full line of Percutaneous Transluminal Angioplasty (PTA), Percutaneous Transluminal Valvuloplasty (PTV) and Aortic Valvuloplastly (BAV) Catheters PTS

1 Family of Diagnostic and Therapeutic Catheters Full line of Percutaneous Transluminal Angioplasty (PTA), Percutaneous Transluminal Valvuloplasty (PTV) and Aortic Valvuloplastly (BAV) Catheters PTS and PTS-X Multi-Track NuCLEUS-X Tyshak NuCLEUS Tyshak Mini Tyshak Tyshak-X Tyshak II Z-5 Atrioseptostomy Z-MED Z-MED II Z-MED-X Z-MED II-X Mini Ghost COEfficient IMPACT Mullins-X B. Braun Interventional Systems Inc. has an unrivaled commitment to providing clinicians with therapeutic catheter options

2 Table of Contents: Indications for Use... 3 PTS and PTS-X Sizing Catheters... 4 Multi-Track Angiographic Catheters... 5 NuCLEUS-X Aortic & Pulmonic Valvuloplasty Catheters... 5 Tyshak NuCLEUS Percutaneous Transluminal Valvuloplasty Catheters... 6 Tyshak Mini Pediatric Percutaneous Transluminal Valvuloplasty Catheters... 7 Tyshak Dilatation Catheters Tyshak-X Percutaneous Transluminal Valvuloplasty Catheters... 9 Tyshak II Percutaneous Transluminal Valvuloplasty Catheters Z-MED Aortic and Pulmonic Valvuloplasty Catheters Z-MED II Aortic and Pulmonic Valvuloplasty Catheters Z-MED-X Percutaneous Transluminal Valvuloplasty Catheters...16 Z-MED II-X Percutaneous Transluminal Valvuloplasty Catheters...17 Z-5 Atrioseptostomy Catheters...18 Mini Ghost Dilatation Catheters COEfficient Percutaneous Transluminal Valvuloplasty Catheters...21 IMPACT Dilatation Catheters cc/30ATM Winged Locking Inflation Device...22 Mullins-X Ultra High Pressure Dilatation Catheters cc/15ATM, 60cc/15ATM Switchback QL Voluminous Inflation Devices...23 Product Matrix...24 Page 2

Indications for Use: The PTS and PTS-X Sizing Catheters are recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the

3 Indications for Use: The PTS and PTS-X Sizing Catheters are recommended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. NuCLEUS-X Valvuloplasty Catheter The IMPACT, Mini Ghost, Mullins-X, and Tyshak Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries. The COEfficient, Mullins-X, Tyshak, Tyshak II, Tyshak NuCLEUS, NuCLEUS-X, Tyshak-X Z-MED, Z-MED II, Z-MED-X and Z-MED II-X Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve..a patient with isolated pulmonary stenosis. A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. The NuCLEUS-X, Z-MED, and Z-MED II Valvuloplasty Catheters are also recommended for Aortic Valvuloplasty (BAV) of the Aortic valve. The Tyshak Mini Catheters are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in pediatric applications..a patient with isolated pulmonary stenosis. A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. The MULTI-TRACK angiographic catheters are recommended for use in catheterization for angiography of cardiovascular vessels and/or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel. The IMPACT Esophageal dilatation catheters (16mm, 18mm, 20mm, 22mm, and 25mm balloon diameters) are indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation therapy. The Z-5 Atrioseptostomy Catheters is recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum. The mm is primarily for infants less than 2 kg. The 25cc/30ATM Inflation Device is recommended for use during the performance of balloon angioplasty procedures to inflate and deflate the balloon and to measure the pressure within the balloon during the procedure. The 40cc/15ATM and 60cc/15ATM Inflation Devices are recommended for use while performing balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon, and deflate the balloon. Refer to the product Instructions for Use for relevant warnings, precautions, complications, and contraindications. Instructions for Use are also available at Page 3

Sizing PTS and PTS-X Sizing Catheters Designed for use in patients with cardiovascular defects where accurate measurements of the defect are important to select the appropriately sized occluder

4 Sizing PTS and PTS-X Sizing Catheters Designed for use in patients with cardiovascular defects where accurate measurements of the defect are important to select the appropriately sized occluder device. PTS-X features a braided inner tubing for tortuous vasculature and prevents buckling during repositioning maneuvers. Braided Inner Tubing Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Length Marker Band: 1.0cm Length 10mm 0.035" Marker Bands 2.0cm Length 5mm 10mm 5mm Marker Bands 4.0cm Length 15mm 10mm 15mm 5.0cm Length 20mm 10mm 20mm 0.035" Page 4 Refer to the product Instructions for Use for more details " Marker Bands 3.0cm Length 10mm 10mm 10mm 0.035" Marker Bands Marker Bands 6.0cm Length 25mm 10mm 25mm Marker Bands 4.0cm Length Marker Bands are measured from leading edge to leading edge " 0.035"

ANGIO Multi-Track Angiographic Catheter Designed with a distal tip offset from the catheter s central lumen to perform angiography without removing the guidewire.

5 1000 psi 615008 2.5 4 80.021 2.7 1000 psi 615004 3 5 60.025 6.5 1000 psi 615005 3 5 80.025 5.5 1000 psi 615006 3 5 100.025 4.0 1000 psi 615002 4 6 80.035 13.0 1000 psi 615003 4 6 100.

0 1000 psi *Catheters with 5Fr shaft size does not feature an imaging band in the tip but has two image bands BAV PTV NuCLEUS-X Aortic & Pulmonic Valvuloplasty Catheter The balloon catheter

612038 18 4 10 9 110 4 0.035 612021 18 5 10 9 110 4 0.035 612039 18 6 10 9 110 4 0.035 612023 20 4 12 9 110 4 0.035 612024 20 5 12 9 110 4 0.035 612025 20 6 12 9 110 4 0.

5 ANGIO Multi-Track Angiographic Catheter Designed with a distal tip offset from the catheter s central lumen to perform angiography without removing the guidewire. Multi-Track has an *imaging band imbedded in its distal tip to visualize catheter placement. Size Flow Rate (ml/sec) Maximum Injection Pressure (PSI) psi psi psi psi psi psi psi A psi psi psi *Catheters with 5Fr shaft size does not feature an imaging band in the tip but has two image bands BAV PTV NuCLEUS-X Aortic & Pulmonic Valvuloplasty Catheter The balloon catheter is designed with a waist formed in the middle to allow accurate balloon placement. Upon reaching a specified pressure, waist will expand to 90% of the rated balloon diameter Page 5

PTV Tyshak NuCLEUS Percutaneous Transluminal Valvuloplasty Catheters This is a Tyshak balloon with a NuCLEUS waist.

612062 4 2 6 5.5 100 5 0.035 612063 4 3 6 5.5 100 5 0.035 612064 5 2 6 5.5 100 5 0.035 612065 5 3 6 5.5 100 5 0.035 612066 5 4 6 5.5 100 5 0.035 612067 6 2 6 5.5 100 5 0.035 612068 6 3 6 5.5 100 5 0.035 612069 6 4 6 5.

5 100 5 0.035 612077 9 3 6 5.5 100 5 0.035 612078 9 4 6 5.5 100 5 0.035 612079 10 2 7 6 100 5 0.035 612080 10 3 7 6 100 5 0.035 612081 10 4 7 6 100 5 0.035 612082 12 2 7 6 100 4.5 0.035 612083 12 3 7 6 100 4.

6 PTV Tyshak NuCLEUS Percutaneous Transluminal Valvuloplasty Catheters This is a Tyshak balloon with a NuCLEUS waist. The balloon is designed with a waist formed in the middle to allow accurate balloon placement. Upon reaching a specified pressure, waist will expand to 90% of the rated balloon diameter Page 6

7 PTV Tyshak Mini Pediatric PTV Dilatation Catheters Designed for insertion through the smallest possible introducer, it features a low profile that allows insertion through 3-4 French introducers Tyshak Dilatation Catheters Due to a coaxial construction, the catheter inflates and deflates extremely fast. The balloon material is thin, allowing for a low deflated profile that maintains tip flexibility. PTA PTV * * A * * * * * *Special Order Page 7

8 PTA PTV Tyshak Dilatation Catheters (more sizes) Due to a coaxial construction, the catheter inflates and deflates extremely fast. The balloon material is thin, allowing for a low deflated profile that maintains tip flexibility * * * * * * * * * * * * * * * * * *Special Order Page 8

9 PTV Tyshak-X Percutaneous Transluminal Valvuloplasty Catheters Tyshak-X features a braided inner tubing that optimizes catheter trackability Page 9

10 PTV Tyshak II Percutaneous Transluminal Valvuloplasty Catheters Tyshak II balloons are super thin for a low deflatable profile that maintains tip flexibility. The distal shaft through the balloon is highly flexible for exceptional maneuverability. This, combined with the pushability of the coaxial shaft provides outstanding tracking performance * * * * * * * * * * * * * * * * * * * * *Special Order Page 10

11 PTV Tyshak II Percutaneous Transluminal Valvuloplasty Catheters (more sizes) * * * * * * * * * * * * * * * * *Special Order Page 11

BAV PTV Z-MED Aortic and Pulmonic Valvuloplasty Catheters Z-MED catheter has a coaxial design with a balloon mounted on its distal tip. Features high rated burst pressures. 610475* 6 2 6 5 100 10 0.

12 BAV PTV Z-MED Aortic and Pulmonic Valvuloplasty Catheters Z-MED catheter has a coaxial design with a balloon mounted on its distal tip. Features high rated burst pressures * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *Special Order Page 12

13 BAV PTV Z-MED Aortic and Pulmonic Valvuloplasty Catheters (more sizes) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *Special Order Page 13

BAV PTV Z-MED II Aortic and Pulmonic Valvuloplasty Catheters Provides high pressure and offers more introducer sizes than the first generation Z-MED.

14 BAV PTV Z-MED II Aortic and Pulmonic Valvuloplasty Catheters Provides high pressure and offers more introducer sizes than the first generation Z-MED. This balloon is designed to insert through the smallest possible introduction sleeve * * * * * * * * * * * * * * * * * * * * * * *Special Order Page 14

BAV PTV Z-MED II Aortic and Pulmonic Valvuloplasty Catheters (more sizes) 611756* 20 3 12 8 100 5 0.035 611757 20 4 12 8 100 5 0.035 611003* 20 4.5 11 10 110 5 0.035 611758* 20 5 12 8 100 5 0.

15 BAV PTV Z-MED II Aortic and Pulmonic Valvuloplasty Catheters (more sizes) * * * * * * * * * * * * * * * * * * * * * * * * * * *Special Order Page 15

PTV Z-MED-X Percutaneous Transluminal Valvuloplasty Catheters Features high rated burst pressures and designed with a braided inner tubing. 618414 10 6 7 6 100 9 0.035 618415 12 2 7 6 100 7 0.

16 PTV Z-MED-X Percutaneous Transluminal Valvuloplasty Catheters Features high rated burst pressures and designed with a braided inner tubing Page 16

PTV Z-MED II-X Percutaneous Transluminal Valvuloplasty Catheters Features high rated burst pressures suitable for resistant stenosis and designed with a braided inner tubing.

035 618711 10 3 7 6 100 13 0.035 618712 10 4 7 6 100 13 0.035 618715 12 2 8 6 100 10 0.035 618716 12 3 8 6 100 10 0.035 618717 12 4 8 6 100 10 0.035 618719 12 6 8 6 100 10 0.

17 PTV Z-MED II-X Percutaneous Transluminal Valvuloplasty Catheters Features high rated burst pressures suitable for resistant stenosis and designed with a braided inner tubing. Rapid inflation and deflation times minimize procedure times and maximize reperfusion Page 17

Catheter tip is angled at 35 degrees to facilitate passage into the left atrium. 611200 9.5 0.95 5 4 50 1 0.014 611100 13.5 1.35 6 5 50 2 0.

18 ATRIO Z-5 Atrioseptostomy Catheters The reduced balloon size is ideal for septostomy in the neonate with a small left atrium. The shape of the spherical balloon does not deform during pullback, allowing the balloon size to be smaller than competitive catheters. Catheter tip is angled at 35 degrees to facilitate passage into the left atrium PTA Mini Ghost Dilatation Catheters The Mini Ghost is a coaxial catheter used for dilatations of the femoral, iliac and renal arteries Page 18

19 PTA Mini Ghost Dilatation Catheters (more sizes) Page 19

20 PTA Mini Ghost Dilatation Catheters (more sizes) Page 20

21 PTV COEfficient Percutaneous Transluminal Valvuloplasty Catheters Engineered for maximum steering and tracking. Designed with enhanced columnar strength for optimal pushablity and trackablility Page 21

PTA IMPACT Dilatation Catheters Offered with a wide range of sizes from 12mm through 25mm in diameter. Esophageal Indication 124120 12 4 8 6 120 10 0.035 124750 12 4 8 6 75 10 0.

035 Yes 182750 18 2 10 8 75 7 0.035 Yes 184120 18 4 10 8 120 7 0.035 Yes 184750 18 4 10 8 75 7 0.035 Yes 202750 20 2 12 8 75 5 0.035 Yes 202120A 20 2 12 8 120 5 0.

035 Yes 224750 22 4 12 9 75 4 0.035 Yes 252120 25 2 14 9 120 4 0.035 Yes 252750 25 2 14 9 75 4 0.035 Yes 254120 25 4 14 9 120 4 0.035 Yes 254750 25 4 14 9 75 4 0.

25cc clear polycarbonate syringe barrel permits easy debubbling. Winged locking mechanism permits easy deflation at high pressures.

22 PTA IMPACT Dilatation Catheters Offered with a wide range of sizes from 12mm through 25mm in diameter. Esophageal Indication Yes Yes Yes Yes Yes Yes Yes A Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 25cc/30ATM Winged Locking Inflation Device 30ATM luminescent analog pressure gauge accommodates most procedures and registers inflation pressure. 25cc clear polycarbonate syringe barrel permits easy debubbling. Winged locking mechanism permits easy deflation at high pressures. 25cc/ 30ATM Inflation Device REF Product Description Case Quantity cc/30ATM Inflation Device with 3-way Stopcock cc/30ATM Inflation Device Kit with 3-way Stopcock, single Y-Connector, Metal Insertion Tool, and LTD Torque Device 10 Winged locking mechanism permits easy deflation at high pressures. Page 22

23 PTA PTV Mullins-X Ultra High Pressure Dilatation Catheters Designed for high pressure dilatation. Braided inner tubing optimizes tracking and kink resistance without sacrificing profile and pressure. The area under the balloon is enhanced with four radiopaque image bands cc/15ATM and 60cc/15ATM SwitchBack QL Voluminous Inflation Devices The SwitchBack QL Voluminous Inflation Devices with luminescent analog pressure gauge are available for a wide array of clinical applications such as balloon dilation. Low-profile design and ergonomic handle make it easy to manipulate. The quick-latch mechanism allows for one-handed deflations even when fully pressurized. The clear polycarbonate syringe barrel accommodates large balloon sizes and provides easy viewing of syringe contents and purging of bubbles. REF Product Description Case Quantity cc/15ATM Inflation Device with 3-way Stopcock cc/15ATM Inflation Device with 3-way Stopcock 10 40cc/15ATM SwitchBack QL Voluminous Inflation Device Clear polycarbonate syringe barrel for easy debubbling of contents Quick latch for immediate deflation Page 23

24 Catheter Diameter (mm) Length (cm) Percutaneous Transluminal Angioplasty (PTA) Size (Fr) Recommended (in) This information is provided for informational purposes only and is not intended to take the place of product labeling. Refer to the Product Instructions for Use supplied with each product for information regarding the product s indications / intended use, contraindications, warnings, and precautions. Instructions for Use are also available on our website: For more information or to place an order, contact your B. Braun Interventional Systems Inc. representative or call Rated Burst Pressures Braided Sheath Page Ref Unique Features IMPACT p. 22 High Rated Mini Ghost pp For dilatations of the femoral, iliac and renal arteries Mullins-X Yes p. 23 High Pressure Dilatation Tyshak pp. 7-8 Extremely Low Profile; Micro Thin Percutaneous Transluminal Valvuloplasty (PTV) Pulmonary COEfficient p. 21 Flexibility, Maximum Steering and Tracking Mullins-X Yes p. 23 High Pressure Dilatation Tyshak NuCLEUS p. 6 Double tapered and waist in middle NuCLEUS-X Yes p. 5 Waist formed in middle for accurate placement Tyshak p. 7-8 Extremely Low Profile Tyshak II pp Super thin balloons for a low deflated profile Tyshak-X Yes p. 9 Extra high inner lumen strength Z-MED pp High Rated Z-MED II pp More Sizes. High pressure dilatation. Z-MED-X Yes p. 16 Increased pushability from braided inner tubing Z-MED II-X Yes p. 17 Increased pushability from braided inner tubing Aortic Valvuloplasty (BAV) NuCLEUS-X Yes p. 5 Waist formed in middle for accurate placement Z-MED pp High Rated Z-MED II pp More introducer sizes and high pressure dilatation Pediatric Percutaneous Transluminal Valvuloplasty (PTV) Tyshak Mini p. 7 Pediatric PTV, Super Thin Atrioseptostomy Z-5 Atrioseptostomy p. 18 Micro Thin ; Spherical Esophageal IMPACT p. 22 High Rated Sizing PTS p. 4 Super Thin, Double Tapered, Used for Sizing PTS-X Yes p. 4 Super Thin, Double Tapered, Used for Sizing Rx only IMPACT, Switchback, and Voluminous are trademarks of B. Braun Interventional Systems Inc. QL is a registered trademark of Atrion Medical Products, Inc. Mini Ghost, Mullins-X, Tyshak NuCLEUS, COEfficient, Multi-Track, NuCLEUS-X, Tyshak-X, Z-MED II, Z-MED-X, Z-MED, Z-MED II-X, Z-5 Atrioseptostomy, and PTS-X, are trademarks of NuMED, Inc. Tyshak, Tyshak II, Tyshak Mini, and PTS are registered trademarks of NuMED, Inc B. Braun Interventional Systems Inc. CV /15 DEHP Not made with DEHP LATEX Not made with natural rubber latex Manufactured for: B. Braun Interventional Systems Inc. 824 Twelfth Avenue Bethlehem, PA USA Tel: Fax:

B. Braun Interventional Systems Inc. Balloon Dilatation Catheter Family

B. Braun Interventional Systems Inc. Balloon Dilatation Catheter Family Rapid Inflation/Deflation High Burst Pressure Balloon Diameters from 2mm to 40mm Mini Ghost Catheter Z-MED-X Catheter Z-MED and Z-MED