PRODUCT CATALOGUE CREATING THE LINKS TO A BETTER WORLD PRODUCTSRODUCTS INTERNATIONAL

Transcription

1 PRODUCT CATALOGUE CREATING THE LINKS TO A BETTER WORLD INTERNATIONAL PRODUCTSRODUCTS

2 NuMED BACKGROUND NuMED Inc. and NuMED Canada Inc., manufacturers of Angioplasty and Valvuloplasty catheters, have a long standing commitment in meeting our customer s expectations by providing a high quality product. At NuMED, we see quality improvement as a continual process, aimed at satisfying these expectations and requirements at every stage. With over 40 years experience in the cardiovascular catheter field, Mr. Allen J. Tower has established the following companies. NuMED Inc., founded in Hopkinton, New York, U.S.A. in 1984, consists of a manufacturing facility; an extrusion facility, which has experience working with and extruding a full range of catheter materials; and a fully equipped Research & Development department, which is responsible for the design feasibility, FDA testing, and introduction of many catheter designs. NuMED Canada Inc., founded in Cornwall, Ontario, Canada in 1990, was originally formed to sell and market medical angioplasty devices purchased from the parent company, to cater to the needs of the worldwide market and with the intent of establishing a manufacturing department. In September 2000, NuMED Canada Inc. moved their operations to a new facility. The new building consists of a modern manufacturing department which caters to the needs of the medical community of over 50 countries world wide with export being 90% of the total product throughput. All NuMED facilities contain environmentally controlled rooms that are monitored on a regular basis. Along with our line of catheters, NuMED is also equipped to do Original Equipment Manufacturer (OEM) contract work for other companies in the industry. Many companies utilize NuMED expertise in the development of OEM products from concept to production. NuMED has become well known for its willingness to work directly with physicians and designers to meet the demanding needs of today s medical community. In the medical industry, quality, reliability and performance are critical. 2

3 CONTENTS 2. NuMED Background PTA Catheters 4. GHOST PTA 5. HIGH FIVE 6. MINI GHOST 8. GHOST II 30. DH 31. DHC PTV Catheters 10. TYSHAK 14. TYSHAK II 17. Z-MED 20. Z-MED II PTV Catheters (Aortic/Mitral) 25. Nucleus Pediatric Valvuloplasty Catheter 16. Tyshak Mini 23. COEfficient Atrioseptostomy Catheter 24. Z-5 Updates Include: -Added special length sizes to Z-MED II pages Added new balloon lengths to Mini Ghost pages 6-7 -Added TYSHAK Mini s page 16 - Added DH and DHC pages Angiographic Catheter 29. Multi-Track Sizing Catheter 27. PTS Stent Placement 28. BIB The devices listed in this brochure are subject to individual country regulations regarding the importation and sale of these products. Back Cover: Contact Information 3

4 Feature: Low profile. Coaxial catheter. Enhanced steerability with rapid inflation and deflation. Double Tapered The GHOST PTA dilatation catheter balloon is tapered at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer. Vessel Conformability NuMED balloons have the ability to conform to vessel shape while maintaining maximum inflation pressure. This reduces trauma to delicate vessel intima. : Non-Compliant Thermoplastic Elastomer. Image Band: GHOST PTA Dilatation catheter Catheter Characteristics The GHOST PTA dilatation catheter is engineered for maximum steerability and pushability. The coaxial shaft design provides a proximal shaft with enhanced column strength for pushability and decreased distal shaft for optimum steerability. Visualization Two image marker bands are placed beneath the shoulders of the balloon to allow reliable positioning of the balloon within the stenosis. Flexible The micro-thin balloon maintains tip flexibility when deflated allowing exceptional trackability through tortuous vessels. High Pressure Non-Compliant The GHOST PTA dilatation catheter provides a micro-thin, non-compliant balloon with a low profile. It has nominal dimensions at the low end of working range and a high rated burst pressure. The flexible tip is achieved using a tapered tip design. It has minimal winging for improved crossability. Ghost PTA Specifications Si ze PTA PTA PTA 522A PTA 501A PTA PTA 508A PTA 523A PTA 503A PTA 510A PTA 524A PTA 505A PTA PTA 512A PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA PTA 520 4

5 Double Tapered The High Five PTA catheter balloon is tapered at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer. Flexible The ultra-high pressure balloon maintains tip flexibility when deflated allowing exceptional trackability through tortuous vessels. Vessel Conformability NuMED balloons have the ability to conform to vessel shape while maintaining maximum inflation pressure. This reduces trauma to delicate vessel intima. Five french shaft. Low profile. Coaxial catheter. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. HIGH FIVE PTA ultra-high pressure catheter Catheter Characteristics The High Five PTA catheter is engineered for maximum steerability and pushability. The coaxial shaft design provides a proximal shaft with enhanced column strength for pushability and decreased distal shaft for optimum steerability. Visualization Two image marker bands are placed beneath the shoulders of the balloon to allow reliable positioning of the balloon within the stenosis. High Pressure Non-Compliant The High Five PTA catheter provides a micro-thin, non-compliant balloon with a low profile. It has nominal dimensions at the low end of working range and a high rated burst pressure. The flexible tip is achieved using a tapered tip design. It has minimal winging for improved crossability. High Five Specifications H H H H H H H H H H H H H H H H H H H H H H H H H H H H H H H H

6 MINI GHOST Dilatation catheter Catheter Characteristics The Mini Ghost is a Coaxial catheter used for dilatations of small vessels. The catheter features a 20.0 or 12.0 atmosphere balloon mounted on 3.5 french shaft. The catheter is available in balloon diameters of 2.0 mm to 6.0 mm and also a variety of balloon and usable lengths. This catheter is not for use in the coronary arteries. Visualization Two image bands are placed beneath the shoulders of the balloon to allow reliable positioning of the balloon within the stenosis. Vessel Conformability NuMED balloons have an ability to conform to vessel shape while maintaining maximum inflation pressure. This reduces trauma to delicate vessel intima. Available in lengths of 40 cm, 80 cm, 120 cm and 150 cm. Feature: Engineered with a low profile balloon on a 3.5 french shaft for small vessel dilatation. Mini Ghost Specifications s ( ) 40CM 80CM 120CM 150CM MG317 MG318 MG319 MG MG321 MG322 MG323 MG MG100 MG101 MG103 MG MG155 MG156 MG157 MG MG104 MG105 MG106 MG MG182 MG183 MG184 MG MG185 MG186 MG187 MG MG188 MG189 MG190 MG MG325 MG326 MG327 MG MG329 MG330 MG331 MG MG107 MG108 MG109 MG MG158 MG159 MG160 MG MG110 MG111 MG112 MG MG191 MG192 MG193 MG MG194 MG195 MG196 MG MG197 MG198 MG199 MG MG333 MG334 MG335 MG MG337 MG338 MG339 MG MG113 MG114 MG115 MG MG161 MG162 MG163 MG MG116 MG117 MG118 MG MG200 MG201 MG202 MG MG203 MG204 MG205 MG MG206 MG207 MG208 MG MG341 MG342 MG343 MG MG345 MG346 MG347 MG MG119 MG120 MG121 MG281 : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. NEW sizes highlighted 6

7 MINI GHOST Dilatation catheter Specifications (cont d) NEW sizes highlighted s ( ) 40CM 80CM 120CM 150CM MG164 MG165 MG166 MG MG122 MG123 MG124 MG MG209 MG210 MG211 MG MG212 MG213 MG214 MG MG215 MG216 MG217 MG MG349 MG350 MG351 MG MG353 MG354 MG355 MG MG125 MG126 MG127 MG MG167 MG168 MG169 MG MG128 MG129 MG130 MG MG218 MG219 MG220 MG MG221 MG222 MG223 MG MG224 MG225 MG226 MG MG357 MG358 MG359 MG MG361 MG362 MG363 MG MG131 MG132 MG133 MG MG170 MG171 MG172 MG MG134 MG135 MG136 MG MG227 MG228 MG229 MG MG230 MG231 MG232 MG MG233 MG234 MG235 MG MG365 MG366 MG367 MG MG369 MG370 MG371 MG MG137 MG138 MG139 MG MG173 MG174 MG175 MG MG140 MG141 MG142 MG MG236 MG237 MG238 MG MG239 MG240 MG241 MG MG242 MG243 MG244 MG MG373 MG374 MG375 MG MG377 MG378 MG379 MG MG143 MG144 MG145 MG MG176 MG177 MG178 MG MG146 MG147 MG148 MG MG245 MG246 MG247 MG MG248 MG249 MG250 MG MG251 MG252 MG253 MG MG381 MG382 MG383 MG MG385 MG386 MG387 MG MG149 MG150 MG151 MG MG179 MG180 MG181 MG MG152 MG153 MG154 MG MG254 MG255 MG256 MG MG257 MG258 MG259 MG MG260 MG261 MG262 MG316 Feature: Engineered with a low profile balloon on a 3.5 french shaft for small vessel dilatation. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 7

8 GHOST II Dilatation catheter Catheter Characteristics The Ghost II is a dual lumen catheter for use in PTA applications. The catheter features a high pressure, low profile balloon mounted on a 5.0 french shaft. This catheter is available in a wide variety of balloon lengths and diameters and also five different usable lengths. This catheter is not for use in the coronary arteries. Visualization The radiopaque marker(s) are placed beneath the 'working area' of the balloon. Vessel Conformability NuMED balloons have an ability to conform to vessel shape while maintaining maximum inflation pressure. This reduces trauma to delicate vessel intima. The shaft length is available in 40 cm, 75 cm, 120 cm, 135 cm, 150 cm. Ghost II Specifications *Nominal Pressure s ( ) 40CM 75CM 120CM 135CM 150CM GII100 GII101 GII102 N/A GII GII104 GII105 GII106 GII322 GII GII108 GII109 GII110 GII323 GII GII112 GII113 GII114 N/A GII GII116 GII117 GII118 N/A GII GII120 GII121 GII122 N/A GII GII124 GII125 GII126 N/A GII GII128 GII129 GII130 N/A GII GII132 GII133 GII134 N/A GII GII136 GII137 GII138 GII324 GII GII250 GII251 GII252 N/A GII GII140 GII141 GII142 GII325 GII GII254 GII255 GII256 N/A GII GII258 GII259 GII260 N/A GII GII262 GII263 GII264 N/A GII GII144 GII145 GII146 N/A GII GII148 GII149 GII150 N/A GII GII152 GII153 GII154 N/A GII GII266 GII267 GII268 N/A GII269 * Pressure at which balloon will not exceed 10% of nominal size. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 8

9 GHOST II Dilatation catheter Specifications (cont d) *Nominal Pressure s ( ) 40CM 75CM 120CM 135CM 150CM GII156 GII157 GII158 N/A GII GII270 GII271 GII272 N/A GII GII274 GII275 GII276 N/A GII GII278 GII279 GII280 N/A GII GII160 GII161 GII162 N/A GII GII164 GII165 GII166 N/A GII GII168 GII169 GII170 N/A GII GII282 GII283 GII284 N/A GII GII172 GII173 GII174 GII326 GII GII286 GII287 GII288 N/A GII GII290 GII291 GII292 N/A GII GII294 GII295 GII296 N/A GII GII176 GII177 GII178 N/A GII GII180 GII181 GII182 N/A GII GII184 GII185 GII186 N/A GII GII188 GII189 GII190 N/A GII GII192 GII193 GII194 N/A GII GII298 GII299 GII300 N/A GII GII302 GII303 GII304 N/A GII GII196 GII197 GII198 N/A GII N/A GII243 N/A N/A N/A GII200 GII201 GII202 N/A GII GII306 GII307 GII308 N/A GII GII204 GII205 GII206 GII327 GII GII310 GII311 GII312 N/A GII GII314 GII315 GII316 N/A GII GII318 GII319 GII320 N/A GII GII208 GII209 GII210 N/A GII GII212 GII213 GII214 N/A GII N/A GII247 N/A N/A N/A GII216 GII217 GII218 N/A GII GII220 GII221 GII222 GII328 GII GII224 GII225 GII226 N/A GII N/A N/A N/A N/A GII248 * Pressure at which balloon will not exceed 10% of nominal size. Feature: Low profile. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 9

10 Feature: Low profile. Coaxial catheter. Maximum steering and tracking. Radiopaque marker Platinum marker bands facilitate reliable positioning of the balloon. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. TYSHAK Percutaneous Transluminal Valvuloplasty Catheter Catheter Characteristics The TYSHAK balloon dilatation catheter is a coaxially constructed catheter with a distally mounted non-compliant balloon. The catheter exhibits an extremely low profile. Due to the coaxial construction, the catheter inflates and deflates extremely fast. The TYSHAK catheter is available in over 100 configurations with balloon lengths from 1.0 to 10.0 cm and balloon diameter from 2.0 to 25.0 mm. Micro-Thin The TYSHAK balloon is super thin for a low deflated profile that maintains tip flexibility. The exceptionally low profile balloon requires the smallest introducer possible. Nominal dimensions are maintained over the entire length of the balloon. Maximum Trackability 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. Tyshak Specifications 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 PDC124 10

11 TYSHAK Percutaneous Transluminal Valvuloplasty Catheter Specifications (cont d) PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC SO PDC PDC PDC PDC SN PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC047 Developed in conjunction with Dr. Tynan and Dr. Qureshi. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 11

12 TYSHAK Percutaneous Transluminal Valvuloplasty Catheter Specifications (cont d) Feature: Low profile. Coaxial catheter. Maximum steering and tracking 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 SO SO PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC046 : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 12

13 TYSHAK Percutaneous Transluminal Valvuloplasty Catheter Specifications (cont d) 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 PDC PDC072 : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. Developed in conjunction with Dr. Tynan and Dr. Qureshi 13

14 TYSHAK II Percutaneous Transluminal Valvuloplasty Catheter Catheter Characteristics The TYSHAK II catheter is a coaxially constructed catheter with a distally mounted non-compliant balloon. The catheter exhibits an extremely low profile that allows the interventionalist to use the smallest introducer possible. Due to the coaxial construction, the catheter inflates and deflates extremely fast. The TYSHAK II catheter provides smaller introducers and in some cases slightly lower burst pressures than the TYSHAK. Super Thin The TYSHAK II PTV balloon is super thin for a low deflated profile that maintains tip flexibility. The exceptionally low profile balloon requires the smallest introducer possible. Nominal dimensions are maintained over the entire length of the balloon. Special Features: 4.0, 5.0, 6.0, 7.0 & 8.0 mm balloons through a four french introducer. Maximum Trackability 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. Radiopaque marker Platinum marker bands facilitate reliable positioning of the balloon. Tyshak II Specifications *Nominal Pressure PDC SN PDC SN SO PDC SN SO PDC SN PDC SN PDC SN PDC SN SO SO SO SO PDC SN SO PDC SN SO SO SO SN SO SO SO SO PDC PDC508 * Pressure at which balloon will not exceed 10% of nominal size. 14

15 TYSHAK II Percutaneous Transluminal Valvuloplasty Catheter Specifications (cont d) *Nominal Pressure SO SO SO SO SO SO SO PDC PDC PDC PDC PDC PDC PDC PDC SN PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC SN PDC PDC PDC PDC SN PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC PDC550 * Pressure at which balloon will not exceed 10% of nominal size. Special Features: 9.0, 10.0, 11.0, 12.0 & 13.0 mm through a five or six french introducer. Developed in conjunction with Dr. Tynan and Dr. Qureshi : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 15

16 TYSHAK MINI Pediatric Valvuloplasty catheter Catheter Characteristics The TYSHAK Mini Pediatric Valvuloplasty catheter has been designed and engineered with a super thin balloon of 2.0 or 4.0 cm in usable length along with a 2.5/3.5 french shaft and mini distal tip, making the TYSHAK Mini the lowest profile of any available balloon in its diameter. Super Thin The TYSHAK Mini Pediatric Valvuloplasty balloon is super thin for a low deflated profile that maintains tip flexibility. The exceptionally low profile balloon requires the smallest introducer possible. Double Tapered The TYSHAK Mini Pediatric Valvuloplasty catheter has short tapers at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer. Radiopaque marker Platinum marker bands facilitate reliable positioning of the balloon. Tyshak Mini Specifications NEW sizes highlighted Developed in conjunction with Dr. Tynan and Dr. Qureshi *Nominal Pressure PDC PDC PDC SO PDC SO PDC SO PDC PDC SO PDC PDC408 * Pressure at which balloon will not exceed 10% of nominal size. Nominal dimensions are maintained over the entire length of the balloon. Special Features: 4.0, 5.0, 6.0, 7.0 & 8.0 mm balloons through a three french introducer. 9.0 & 10.0 mm balloons through a four french introducer. 2.0 & 4.0 cm balloon length combined with a mini tapered tip. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 16

17 Z-MED Percutaneous Transluminal Valvuloplasty Catheter Catheter Characteristics The Z-MED high pressure dilatation catheter is a coaxially constructed catheter with a distally mounted non-compliant high pressure balloon. The catheter exhibits a comparable profile to other marketed catheters but also combines this profile with a high pressure balloon suitable for resistant stenosis. The Z-MED balloon catheter is available in over 50 configurations ranging in diameter from 2.0 to 40.0 mm. The Z-MED PTV balloon has a low deflated profile that maintains tip flexibility. The exceptionally low profile balloon requires the smallest introducer possible. Nominal dimensions are maintained over the entire length of the balloon. Maximum Trackability 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. Z-Med Specifications SO SO SO PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ SN PDZ SN SN PDZ SN PDZ PDZ318 Developed in Conjunction with Dr. Ziyad Hijazi Radiopaque Marker Platinum marker bands facilitate reliable positioning of the balloon. 17

18 Z-MED Percutaneous Transluminal Valvuloplasty Catheter Specifications (cont d) Feature: Low profile. High pressure balloon. Maximum steering and trackability. Coaxial catheter PDZ PDZ SN SN PDZ PDZ SN PDZ PDZ PDZ PDZ SO PDZ SN PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ SN PDZ PDZ PDZ SN SO PDZ PDZ SN PDZ PDZ PDZ PDZ PDZ SO PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ PDZ SO PDZ PDZ PDZ PDZ SO005 18

19 Z-MED Percutaneous Transluminal Valvuloplasty Catheter Specifications (cont d) Si ze SO SO PDZ PDZ PDZ SO SO SO SO SO SO SO SO SN PDZ SO SO PDZ PDZ PDZ PDZ PDZ SO SO SO SO SO SO SO SO SO SO PDZ PDZ SO SO SO SO SO SO PDZ SO PDZ PDZ SO SO SO SO SO SO SO078 Developed in Conjunction with Dr. Ziyad Hijazi 19

20 Z-MED II Percutaneous Transluminal Valvuloplasty Catheter Catheter Characteristics The Z-MED II dilatation catheter provides higher pressure and in some instances a larger introducer than the Z-MED. The coaxial shaft design provides enhanced column strength and pushability combined with a flexible distal tip for optimum steerability. The Z-MED II balloon catheter is available in configurations ranging from 4.0 to 30.0 mm in diameter. Radiopaque Marker Platinum marker bands facilitate reliable positioning of the balloon. Maximum Trackability 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. Feature: High pressure balloon. Maximum steering and trackability. Coaxial catheter. Catheter Body: Polymeric. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. Z-Med II Specifications * Pressure at which balloon will not exceed 10% of nominal size. NEW sizes highlighted *Nominal Pressure PDZ SN PDZ PDZ PDZ PDZ PDZ SN PDZ PDZ PDZ PDZ PDZ SN PDZ PDZ PDZ PDZ PDZ SN PDZ PDZ PDZ PDZ PDZ SN PDZ PDZ PDZ PDZ PDZ SN PDZ PDZ627 20

21 Z-MED II Specifications (cont d) NEW sizes highlighted *Nominal Pressure PDZ PDZ PDZ SN PDZ PDZ PDZ PDZ SN SO SO PDZ SN SO PDZ PDZ PDZ PDZ SN SN SN 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 SO044 * Pressure at which balloon will not exceed 10% of nominal size. Developed in Conjunction with Dr. Ziyad Hijazi 21

22 Z-MED II Specifications (cont d) *Nominal Pressure Feature: High pressure balloon. Maximum steering and trackability. Coaxial catheter PDZ PDZ PDZ SO SO PDZ SO PDZ PDZ PDZ PDZ SO PDZ SO PDZ SO SO PDZ675 * Pressure at which balloon will not exceed 10% of nominal size. 22

23 COEfficient Pediatric Valvuloplasty catheter Catheter Characteristics The COEfficient Pediatric Valvuloplasty catheter is engineered for maximum steering and tracking. The coaxial shaft design provides enhanced column strength and pushability combined with a flexible distal tip for optimum steerability. Developed in conjunction with Dr. Yashu Coe of the University of Alberta, Edmonton, Alberta, Canada. Radiopaque Marker Platinum marker bands facilitate reliable positioning of the balloon. The COEfficient Pediatric Valvuloplasty balloon has a low deflated profile that maintains tip flexibility. The exceptionally low profile balloon requires the smallest introducer possible. Nominal dimensions are maintained over the entire length of the balloon. COEfficient Specifications s ( ) 75CM 135CM COE101 COE COE102 COE COE103 COE COE104 COE COE105 COE COE106 COE COE107 COE COE108 COE COE109 COE COE110 COE COE111 COE COE112 COE COE113 COE COE114 COE COE115 COE SN032 N/A COE116 N/A COE117 COE COE118 COE COE119 N/A COE120 COE COE121 COE COE122 N/A COE123 COE COE124 COE COE125 N/A COE126 COE COE127 COE154 Feature: Low profile. High pressure balloon. Coaxial catheter. Maximum Trackability 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. Catheter Body: Polymeric. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. Another addition to the quality NuMED line of balloons. 23

24 Z-5 Atrioseptostomy catheter Catheter Characteristics The NuMED Z-5 Atrioseptostomy catheter is engineered for maximum steering and tracking. The dual lumen shaft design provides pushability, coupled with exceptional pull strength. This new innovation in Atrioseptostomy catheter design is of potential importance in patients who are subject to a small left Atrium and in small neonates with congenital heart disease requiring Atrioseptostomy. Radiopaque Catheter Body & Image Marker The NuMED Z-5 Atrioseptostomy catheter body is Radiopaque to facilitate reliable positioning of the catheter. A platinum image marker band is placed under the balloon for clear identification under fluoroscopy. Micro-Thin Non-Compliant The NuMED Z-5 Atrioseptostomy balloon is micro-thin for low deflated profile that maintains tip flexibility. The Inflation of the balloon is controlled by volume. (see volumetric chart-instructions for Use) Developed in conjunction with Dr. Ziyad Hijazi Reduced The reduced inflated balloon size makes the Atrioseptostomy easier to perform on neonates with a small left atrium. Tip Angulation The tip of the catheter is angled at 35 o to facilitate passage into the left atrium. Inner Lumen The NuMED Z-5 Atrioseptostomy catheter has an inner lumen. The catheter end hole can accommodate a guidewire. Z-5 Specifications Maximum Volume (CC) SPT SPT003 Reference: Z.Hijazi. R.Geggel. M.Aronovitz. G.Marx, J.Rhodes, D.Fulton. "A new low profile balloon atrial septostomy catheter. Initial animal and clinical experience." : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 24

25 NUCLEUS Percutaneous Transluminal Valvuloplasty Catheter (Patent # 5,352,199) Catheter Characteristics The NuMED NuCLEUS PTV catheter is engineered for maximum steering and tracking. The coaxial shaft design provides enhanced column strength and pushability combined with a flexible distal tip for optimum steerability. The innovative single balloon design facilitates positive positioning while holding the balloon in the correct location prior to and during inflation. Radiopaque Marker Platinum marker bands facilitate reliable positioning of the balloon and are located at the 'waist' center and beneath the shoulders of the balloon for clear identification under fluoroscopy. Maximum Trackability 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. Micro-Thin Non-Compliant The NuMED NuCLEUS PTV patented design allows for accurate balloon placement. Initial inflation will hold balloon in the desired position, further inflation expands the center of the balloon to effect satisfactory dilatation. The NuMED NuCLEUS PTV balloon is micro-thin for a low deflated profile that maintains tip flexibility. The exceptionally low profile balloon requires the smallest introducer possible. Nominal dimensions are maintained over the entire length of the non-compliant balloon. Feature: Low profile. Coaxial catheter. Maximum steering and trackability. Nucleus Specifications (cm) NEW sizes highlighted PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN243 : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 25

26 NUCLEUS Specifications (cont d) (cm) NEW sizes highlighted PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN PVN255 Feature: Low profile. Coaxial catheter. Maximum steering and trackability. For information regarding inflation graduations at various pressures and fluid volumes, refer to NuMED NuCLEUS inflation characteristics within the instructions for use booklet. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 26

27 PTS Specifications PTS Sizing catheter Catheter Characteristics The PTS Sizing catheter has been designed for use in patients with cardiovascular defects where accurate measurement of the defect is important to select the appropriately sized occluder device. Super Thin The PTS Sizing catheter is super-thin for a low deflated profile that maintains tip flexibility. Double Tapered The PTS Sizing catheter has short tapers at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer. Designed for controlled low pressure inflation PTS PTS PTS PTS PTS PTS PTS PTS405 For Reference: Radiopaque marker Platinum marker bands facilitate reliable positioning of the balloon and calibration for accurately sizing the defect. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. Physicians a technicaly superior option in dealing with clinical needs. 27

28 BIB Stent Placement catheter* for vessels over 8.0 mm in diameter Available ONLY through NuMED Inc. All Catheters have: An inner balloon 1/2 of the balloon diameter of the outer balloon. i.e. BB010 has an 8.0 mm inner balloon. An inner balloon that is 1.0 cm shorter than the outer balloon. i.e. BB010 has an inner balloon that is 2.0 cm long. An inner balloon with a rated burst pressure of 4.5 to 5.0 atmospheres. Four image bands that match the functional length of each balloon. A length of 110 cm. All Catheters are for use with a 0.035" wire. * NOT FOR SALE IN THE U.S.A. Outer Specifications BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB BB021 28

29 MULTI-TRACK Angiographic catheter The MULTI-TRACK angiographic catheter utilizes a unique concept of guidewire location to increase flow rate and maneuverability of the catheters. Designed from radiopaque materials, the catheters are easily placed and can be used in conjunction with different types of interventional catheters. The MULTI-TRACK angiographic catheters innovative offset distal tip passes over-the-wire, leaving the catheter shaft free for infusion of contrast media or for obtaining pressure measurements. This allows the guidewire to remain in position throughout the procedure. The MULTI-TRACK angiographic catheter system allows for high quality angiography and pressure recordings during diagnostic and interventional cardiac catheterization. The advantage of the system is that both angiography and pressure recording can be performed repeatedly from stable catheter positions using a previously placed guidewire. This reduces the need for guidewire manipulations or catheter exchanges and decreases procedure time and the risk of complications. Multi-Track Specifications Flow Rate (ml/sec) Maximum Injection (PSI) Tip Details MMTA MMTA MMTA MMTA MMTA MMTA MMTA MMTA MMTA MMTA06100 Available ONLY through NuMED Inc. Feature: Distal tip offset from catheter s central lumen. Developed in cooperation with Dr. Philipp Bonhoeffer and Jêan-Francois Piêchaud There are multiple potential uses for the MULTI-TRACK catheter. It simplifies many procedures, enabling clinicians to: Perform angiography without removing and repositioning the guidewire Obtain simultaneous gradient pressure measurements Place multiple catheters on the guidewire Precisely control pull-back or push-up pressure tracings 5.0 French Image Bands * Other than 5.0 French Platinum Image Bands located inside tip 10 mm REVERSE SIDE Image Bands * 10 mm MULTI-TRACK PORT AND TIP NOTE: X = is the hole facing you. O = is the hole on the opposite side of the shaft. * Image Bands are 10.0 mm, leading edge to leading edge. MULTI-TRACK PORT AND TIP A new tool for complex catheterization in congenital heart disease 29

30 DH PTA ultra-high pressure catheter Catheter Characteristics The DH PTA catheter is engineered for maximum steerability and pushability. The coaxial shaft design provides a proximal shaft with enhanced column strength for pushability and decreased distal shaft for optimum steerability. Visualization Two image marker bands are placed beneath the shoulders of the balloon to allow reliable positioning of the balloon within the stenosis. High Pressure Non-Compliant The DH PTA catheter provides a micro-thin, non-compliant balloon with a low profile. It has nominal dimensions at the low end of working range and a high rated burst pressure. The flexible tip is achieved using a tapered tip design. It has minimal winging for improved crossability. DH Specifications DH DH DH DH DH DH DH DH DH DH DH DH DH DH DH DH DH DH DH DH10490 Double Tapered The DH PTA catheter balloon is tapered at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer. Flexible The ultra-high pressure balloon maintains tip flexibility when deflated allowing exceptional trackability through tortuous vessels. Vessel Conformability NuMED balloons have the ability to conform to vessel shape while maintaining maximum inflation pressure. This reduces trauma to delicate vessel intima. NOT FOR SALE IN THE U.S.A. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 30

31 DHC PTA ultra-high pressure catheter - Curved Catheter Characteristics The DHC Curved PTA catheter is engineered for maximum steerability and pushability. The coaxial shaft design provides a proximal shaft with enhanced column strength for pushability and decreased distal shaft for optimum steerability. Visualization Two image marker bands are placed beneath the shoulders of the balloon to allow reliable positioning of the balloon within the stenosis. High Pressure Non-Compliant The DHC Curved PTA catheter provides a micro-thin, non-compliant balloon with a low profile. It has nominal dimensions at the low end of working range and a high rated burst pressure. The flexible tip is achieved using a tapered tip design. It has minimal winging for improved crossability. Double Tapered The DHC Curved PTA catheter balloon is tapered at the distal and proximal ends for enhanced transition across the stenosis and post dilatation ease of withdrawal into the introducer. Flexible The ultra-high pressure balloon maintains tip flexibility when deflated allowing exceptional trackability through tortuous vessels. Vessel Conformability NuMED balloons have the ability to conform to vessel shape while maintaining maximum inflation pressure. This reduces trauma to delicate vessel intima. DHC Curved Specifications DHC DHC DHC DHC DHC DHC DHC DHC DHC DHC DHC DHC DHC DHC8460 Feature: Low profile. Coaxial catheter. NOT FOR SALE IN THE U.S.A. : Non-Compliant Thermoplastic Elastomer. Image Band: Platinum Iridium. 31

32 CONTACT INFORMATION NuMED For Children Manufactured By: NuMED Inc Main Street Hopkinton, NY USA Tel: (315) Fax: (315) Customer Service Order Entry NuMED Canada Inc. 45 Second Street West Cornwall, ON K6J 1G3 Canada Tel: (613) Fax: (613) Customer Service Order Entry Allen J. Tower, CEO Allen Tower Jr., President Doug Villnave, VP R&D General Manager QS Manager QC - QA Manager numedqc@numed.on.ca General Information numedcanada@numed.on.ca G. van Wageningen B.V. European Representative info@heartmedical.nl Hallenweg CT Best The Netherlands Tel: Fax: Visit us on the World Wide Web NCI Rev. 50