Diagnostic and Therapeutic Catheters Full line of Percutaneous Transluminal Angioplasty (PTA), Percutaneous Transluminal Valvuloplasty (PTV) and Balloon Aortic Valvuloplasty (BAV) Catheters B. Braun Interventional Systems Inc. has an unrivaled commitment to providing clinicians with therapeutic catheter options 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™
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Diagnostic and Therapeutic CathetersFull line of Percutaneous Transluminal Angioplasty (PTA), Percutaneous Transluminal Valvuloplasty (PTV) and Balloon Aortic Valvuloplasty (BAV) Catheters
B. Braun Interventional Systems Inc. has an unrivaled commitment to providing clinicians with therapeutic catheter options
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Table of Contents:
Indications for Use ................................................................................................................................................................................. 3
PTS® and PTS-X™ Sizing Balloon Catheters ................................................................................................................................... 4
Mini Ghost™ Dilatation Catheters ............................................................................................................................................18-20
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Indications for Use:NuCLEUS-X™ Balloon Valvuloplasty Catheter
The PTS® and PTS-X™ Sizing Balloon 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.
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.
•Apatientwithvalvularpulmonarystenosiswith 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 Balloon 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.
•Apatientwithvalvularpulmonarystenosiswithotherminor 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 are recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon 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 611200 - 9.5 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 www.bisusa.org
Page 3
B. Braun Interventional Systems Inc. Call 1-877-836-2228
PTS® and PTS-X™ Sizing Balloon CathetersDesigned 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.
5.0cm Balloon Length
6.0cm Balloon Length
0.035"Marker Bands
20mm 10mm 20mm
4.0cm Balloon Length
0.035"
15mm 10mm 15mm
Marker Bands
3.0cm Balloon Length
0.035"
10mm 10mm 10mm
Marker Bands
2.0cm Balloon Length
0.035"
5mm 10mm 5mm
Marker Bands
Marker Bands
1.0cm Balloon Length
0.035"
10mm
0.035"Marker Bands
25mm 10mm 25mm
5.0cm Balloon Length
6.0cm Balloon Length
0.035"Marker Bands
20mm 10mm 20mm
4.0cm Balloon Length
0.035"
15mm 10mm 15mm
Marker Bands
3.0cm Balloon Length
0.035"
10mm 10mm 10mm
Marker Bands
2.0cm Balloon Length
0.035"
5mm 10mm 5mm
Marker Bands
Marker Bands
1.0cm Balloon Length
0.035"
10mm
0.035"Marker Bands
25mm 10mm 25mm
Balloon Length Marker Band:
Marker Bands are measured from leading edge to leading edge.
Refer to the product
Instructions for Use for more details.
Page 4
Sizing
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Multi-Track™ Angiographic CatheterDesigned 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.
NuCLEUS-X™ Balloon 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.
*Catheters with 5Fr shaft size does not feature an imaging band in the tip but has two image bands
Page 5
BAV PTV
ANGIO
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Tyshak NuCLEUS™ Percutaneous Transluminal Valvuloplasty CathetersThis 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
PTV
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Tyshak Mini® Pediatric PTV Dilatation CathetersDesigned for insertion through the smallest possible introducer, it features a low profile that allows insertion through 3-4 French introducers.
Tyshak® Dilatation CathetersDue 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.
B. Braun Interventional Systems Inc. Call 1-877-836-2228
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.
B. Braun Interventional Systems Inc. Call 1-877-836-2228
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.
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Z-MED™ Balloon Aortic and Pulmonic Valvuloplasty CathetersZ-MED™ catheter has a coaxial design with a balloon mounted on its distal tip. Features high rated burst pressures.
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Z-MED II™ Balloon Aortic and Pulmonic Valvuloplasty CathetersProvides 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.
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Z-MED II-X™ Percutaneous Transluminal Valvuloplasty CathetersFeatures 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.
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Z-5™ Atrioseptostomy CathetersThe 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.
COEfficient™ Percutaneous Transluminal Valvuloplasty CathetersEngineered for maximum steering and tracking. Designed with enhanced columnar strength for optimal pushability and trackability.
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PTV
B. Braun Interventional Systems Inc. Call 1-877-836-2228
Mullins-X™ Ultra High Pressure Dilatation CathetersDesigned 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.
Clear polycarbonate syringe barrel for easy debubbling of contents
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 Number Product Description Case
Quantity
622513 40cc/15ATM Inflation Device with 3-way Stopcock 10
622519 60cc/15ATM Inflation Device with 3-way Stopcock 10
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40cc/15ATM and 60cc/15ATM SwitchBack™ QL® Voluminous™ Inflation Devices
PTAPTV
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: www.bisusa.org
For more information or to place an order, contact yourB. Braun Interventional Systems Inc. representative or call877-836-2228
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 registeredtrademarks of NuMED, Inc.