B. Braun Interventional Systems Inc. Balloon Dilatation Catheter Family
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1 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 II Catheters COEfficient Catheter IMPACT Large Diameter Catheter B. Braun Interventional Systems Inc. has an unequaled commitment to providing clinicians with therapeutic options. X -Line, COEfficient, Mini Ghost, Z-MED and Impact Balloon Dilatation Catheters are offered in a wide variety of sizes and feature high-rated burst pressures.
2 Mini Ghost Balloon Catheters and COEfficient PTV Balloon Di la ta tion Catheters Mini Ghost Ordering Information Recommended Rated 40cm 80cm 120cm 150cm Balloon Balloon Introducer Burst REF REF REF REF Diameter Length Size Pressure Number Number Number Number (mm) (cm) (FR) (ATM) N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Shaft size for all Mini Ghost Balloon Dilatation Catheters is 3.5. Recommended Rated 40cm 80cm 120cm 150cm Balloon Balloon Introducer Burst REF REF REF REF Diameter Length Size Pressure Number Number Number Number (mm) (cm) (FR) (ATM) N/A N/A Mini Ghost Balloon 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. Mini Ghost Balloon Dilatation Catheters fea ture high-rated burst pressures from ATM and balloon diameters from 2-6mm for peripheral transluminal angioplasty. COEfficient PTV Balloon Dilatation Catheters are designed with a low profile that delivers performance, and a co-axial shaft and flexible tip for optimal pushability, trackability and maneuverability. COEfficient Ordering Information Recommended Rated 75cm 135cm Balloon Balloon Introducer Burst REF REF Diameter Length Size Pressure Number Number (mm) (cm) (FR) (ATM) COEfficient PTV Balloon Dilatation Catheters are recommended for percutaneous transluminal valvuloplasty (PTV) of the pulmonary valve. A patient with isolated pulmonary stenosis. A patient with pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
3 IMPACT Balloon Di la ta tion Catheters Ordering Information IMPACT Balloon Dilatation Catheters are available in a range of balloon diameters from 12-25mm for peripheral transluminal angioplasty and esoph ageal dilatation in 16-25mm sizes only. IMPACT catheters provide rapid inflation/deflation times to minimize procedure times and also feature a co-axial shaft design and flexible tip for optimal pushability, trackability and ma neu ver abil i ty. The IMPACT balloon dilatation catheter is indicated for use in adult and adolescent patients to dilate esophageal strictures due to: esophageal surgery, primary gastroespoh reflux, radiation therapy. Rated Burst Pressures IMPACT Shaft Recommended Rated Balloon Balloon Usable Introducer Shaft Burst Nominal REF Diameter Length Length Size Size Pressure Pressure Number (mm) (cm) (cm) (F) (F) (ATM) (ATM) A Recommended guidewire for all IMPACT Balloon Dilatation Catheters is in. Average Inflation Times* (sec.) Average Deflation Times* (sec.) XXL XXL * Inflation/deflation times performed using B. Braun inflation device (622510) with 20cc of a 1-1 mix of MD-60 contrast and water at room temperature.
4 Z-MED-X and Z-MED II-X PTV Balloon Di la ta tion Catheters Ordering Information Z-MED-X Recommended Rated Balloon Balloon Introducer Shaft Burst REF Model Diameter Length Size Size Pressure Number Number (mm) (cm) (F) (F) (ATM) PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ Z-MED II-X Recommended Rated Balloon Balloon Introducer Shaft Burst Nominal REF Model Diameter Length Size Size Pressure Pressure Number Number (mm) (cm) (F) (F) (ATM) (ATM) PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ Recommended guidewire for all Z-MED-X and Z-MED II-X Balloon Dilatation Catheters is in. Usable length is 100cm.
5 Z-MED and Z-MED II Balloon Di la ta tion Catheters Ordering Information Z-MED Recommended Rated Shaft Balloon Balloon Introducer Shaft Burst Usable Recommended REF Model Diameter Length Size Size Pressure Length Guidewire Number Number (mm) (cm) (F) (F) (ATM) (cm) (In) The Z-MED Family of Balloon Dilatation Catheters offers clinicians choices to meet demanding clinical needs. Z-MED catheters are available in the widest range of sizes (2-40mm) and feature high-rated burst pressures. Rapid inflation and deflation times minimize pro ce dure times and maximize reperfusion. Short, flexible distal tips with short balloon tapers aid ma neu ver abil i ty and trackability through tortuous anatomy. Well-defined balloon shoulders and a co-axial shaft design provide columnar strength for exceptional pushability. Z-MED Catheters are also available in a large selection of special order sizes PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ Z-MED II Recommended Rated Balloon Balloon Introducer Shaft Burst Rec. Nominal REF Model Diameter Length Size Size Pressure Guidewire Pressure Number Number (mm) (cm) (F) (F) (ATM) (In) (ATM) Burst Pressure (ATM) Rated Burst Pressure Range for Z-MED II vs. Boston Scientific XXL Large Balloon Dilatation Catheter Z-MED II XXL XXL Balloon Diameter (mm) PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ Usable shaft length for the above Z-MED II ballooons is 100 cm. See back of brochure for special order sizes.
6 Tyshak-X PTV Balloon Di la ta tion Catheters and MULLINS-X Ultra High Pressure Dilatation Catheters Tyshak-X Ordering Information Recommended Rated Balloon Balloon Introducer Shaft Burst REF Model Diameter Length Size Size Pressure Number Number (mm) (cm) (F) (F) (ATM) PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC X Line Balloon Dilatation Catheters are designed with a braided inner tubing that optimizes catheter trackability to prevent kinking and buckling in tortuous vasculature without sacrificing profile or pressure. The X Line Balloon Dilatation Catheters are available in sizes ranging from 8-30mm with a rated burst pressure ranging from ATM. MULLINS-X Ordering Information Recommended Rated Balloon Balloon Introducer Shaft Burst REF Model Diameter Length Size Size Pressure Number Number (mm) (cm) (F) (F) (ATM) PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM PTM Recommended guidewire for all Tyshak-X and MULLINS-X Balloon Dilatation Catheters is in. Usable length is 100cm.
7 Z-MED Special Order Recommended Rated Shaft Balloon Balloon Introducer Shaft Burst Usable Recommended REF Model Diameter Length Size Size Pressure Length Guidewire Number Number (mm) (cm) (F) (F) (ATM) (cm) (In) SO SO SO PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ S SO PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ SO PDZ PDZ PDZ PDZ PDZ SO PDZ PDZ PDZ PDZ PDZ Recommended Rated Shaft Balloon Balloon Introducer Shaft Burst Usable Recommended REF Model Diameter Length Size Size Pressure Length Guidewire Number Number (mm) (cm) (F) (F) (ATM) (cm) (In) PDZ SO PDZ PDZ PDZ PDZ SO SO SO PDZ SO SO SO SO SO SO PDZ SO SO SO SO SO SO PDZ PDZ PDZ PDZ SO SO SO SO SO SO SO SO SO SO SO SO PDZ SO SO SO SO SO SO SO PDZ SO SO SO S SO SO SO SO SO SO
8 Z-MED II Special Order Rec. Rated Shaft Balloon Balloon Intro. Shaft Burst Usable Rec. Nominal REF Model Diameter Length Size Size Pressure Length Guidewire Pressure Number Number (mm) (cm) (F) (F) (ATM) (cm) (In) (ATM) PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ A PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ SO SO S S PDZ PDZ Rec. Rated Shaft Balloon Balloon Intro. Shaft Burst Usable Rec. Nominal REF Model Diameter Length Size Size Pressure Length Guidewire Pressure Number Number (mm) (cm) (F) (F) (ATM) (cm) (In) (ATM) PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ SO PDZ PDZ SO SO PDZ SO PDZ PDZ SO PDZ SO PDZ SO SO PDZ The Mini Ghost, Z-MED, Z-MED II and IMPACT 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, Z-MED-X, Z-MED II-X, Tyshak X, Z-MED and Z-MED II are recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve. A patient with isolated pulmonary stenosis. A patient with pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention. Refer to the Mini Ghost, Z-MED, Z-MED II, IMPACT, Tyshak-X, Z-MED-X, Z-MED II-X, MULLINS-X and COEfficient instructions for use for relevant warnings, precautions, complications and contraindications. Caution: Federal law restricts this device to sale by or on the order of a physician. For more information on our family of standard and special order balloon dilatation catheters, contact your B. Braun Interventional Systems Inc. representative or call VENA CAV ( ) Rx only IMPACT is a trademark of B. Braun Interventional Systems Inc. Z-MED is a trademark of NuMED, Inc. Medi Tech is a registered trademark of Boston Scientific Corporation XXL is a trademark of Boston Scientific Corporation 2010 B. Braun Interventional Systems Inc. CV965-12/10 DEHP DEHP free LATEX Components and packaging do not contain natural rubber latex Manufactured By: NuMED, Inc Main St. Hopkinton, NY Manufactured for: B. Braun Interventional Systems Inc. 824 Twelfth Avenue Bethlehem, PA Tel: VENA CAV ( ) Fax:
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