CP STENT. Balloon Expandable Stent up to 30mm in Diameter

Transcription

1 CP STENT Expandable up to 30mm in

2 CP STENT OPTIONS: Available in 8 zig and 10 zig, Covered or Bare, Unmounted and Pre-Mounted 8 ZIG 12mm to 24mm Expansion 10 ZIG 26mm to 30mm Expansion Size Matrix: ( of Zigs) ZIG 10 ZIG CP Details: CP is composed of platinum-iridium wire arranged in either an 8 zig or 10 zig pattern The 8 zig configuration is expandable from 12mm - 24mm in diameter with lengths ranging from 1.6cm to 6.0cm The 10 zig configuration is expandable from 26mm - 30mm in diameter with lengths ranging from 3.9cm to 6.0cm Visit our web site for more info: NuMED offers Physicians speedy response to catheter design and manufacturing service. The enhanced catheter technology offers Physicians a technically superior option in dealing with clinical needs.

3 (CM) NuMED recommends using the BIB Placement Catheter. Covered Mounted CP System Specifications ( of Zigs) COVERED CP STENT Coarctation of the Aorta and RVOT* This stent comes in both unmounted and pre-mounted configurations. Characteristics The Covered CP is composed of platinum/iridium wire that is arranged in a zig pattern that is laser welded at each joint and then over brazed with 24K gold. The stent is then covered with an expandable sleeve of eptfe. The 8 zig configuration allows expansion from 12 mm to 24 mm, and the 10 zig configuration allows expansion from 26 mm to 30 mm. The pre-mounted configuration is the Covered CP mounted on a BIB Catheter. This system will save the physician the time required to mount the stent on the catheter. Covered No CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP8Z CVRDCP10Z CVRDCP10Z CVRDCP10Z CVRDCP10Z CVRDCP10Z60 ( of Zigs) Profile (Fr) All of these stents are mounted by hand at NuMED, Inc. This may be critical in some cases of aneurysmal repair. (ATM) of Zigs on 8 10 Covered Mounted CP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP011 BIB Delivery Catheter 12MM 14MM 15MM 16MM 18MM 20MM 22MM 24MM 26MM 28MM 30MM Required Introducer with Covered CP 14F 14F 14F 14F 16F 18F 18F

4 Covered Mounted CP System Specifications (cont d) ( of Zigs) Profile (Fr) (ATM) Covered Mounted CP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP ZIG COVERED CP STENT MOUNTED ON A BIB CATHETER

5 Covered Mounted CP System Specifications (cont d) ( of Zigs) Profile (Fr) (ATM) Covered Mounted CP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP CMCP058 All catheters have a usable length of 110cm and use a Guidewire * Refer to the Instructions for Use for the complete listing of Indication, Contraindications, Warnings, and Precautions.

6 CP STENT Coarctation of the Aorta* This stent comes in both unmounted and pre-mounted configurations. Characteristics The CP is composed of platinum/iridium wire that is arranged in a zig pattern that is laser welded at each joint and then over brazed with 24K gold. The 8 zig configuration allows expansion from 12 mm to 24 mm, and the 10 zig configuration allows expansion from 26 mm to 30 mm. The pre-mounted configuration is the bare CP mounted on a BIB Catheter. This system will save the physician the time required to mount the stent on the catheter. All of these stents are mounted by hand at NuMED, Inc. NuMED recommends using the BIB Placement Catheter. CP Specifications (CM) ( of Zigs) Bare No. * Refer to the Instructions for Use for the complete listing of Indication, Contraindications, Warnings, and Precautions CP8Z CP8Z CP8Z CP8Z CP8Z CP8Z CP8Z CP8Z CP8Z CP10Z CP10Z CP10Z CP10Z CP10Z60 Mounted CP System Specifications ( of Zigs) Profile (Fr) of Zigs on 8 10 (atm) BIB Delivery Catheter 12MM 14MM 15MM 16MM 18MM 20MM 22MM 24MM 26MM 28MM 30MM Mounted CP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP016 Required Introducer with Bare CP 10F 10F 11F 11F 11F 16F 16F 16F

7 Mounted CP System Specifications (cont d) ( of Zigs) Profile (Fr) (atm) Mounted CP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP079

8 Mounted CP System Specifications (cont d) ( of Zigs) Profile (Fr) (atm) Mounted CP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP MCP058 All catheters have a usable length of 110cm and use a Guidewire * Refer to the Instructions for Use for the complete listing of Indication, Contraindications, Warnings, and Precautions. SAFETY AND EFFECTIVENESS CLINICAL DATA: Coarctation Of the Aorta Trial (COAST: NCT ) The CP was tested and found to be safe and effective to widen the narrow part of the aorta related to coarctation of the aorta. Covered CP s for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (COASTII: NCT ) The Covered CP was tested and found to be safe and effective to repair aortic wall injuries and widen the narrow part of the aorta related to coarctation of the aorta. Pulmonary Artery Repair With Covered s (PARCS: NCT ) The Covered CP was tested and found to be safe and effective to use as a treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR). CP Indications for Use: The CP is indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving a compliant aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery and balloon angioplasty is contraindicated or predicted to be ineffective. The Covered CP is indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving the aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery associated with one or more of the following: acute or chronic wall injury; nearly atretic descending aorta of 3 mm or less in diameter; a non-compliant stenotic aortic segment found on pre-stent balloon dilation; a genetic or congenital syndrome associated with aortic wall weakening or ascending aortic aneurysm. Covered CP is indicated for use in the treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement. BIB Indications for Use: The BIB Catheter is indicated for CP /Covered CP placement in vessels over 8mm in diameter. Reference the IFU for a complete listing of indications, contraindications, warnings and precautions.

9 BIB Placement catheter Specifications (MM) (CM) Introducer Size (FR) Shaft Size (FR) (ATM) No 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 BB067 INNER BALLOON OUTER BALLOON BIB Catheter 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. Four image bands that match the functional length of each balloon. A usable length of 110 cm. All BIB Catheters are for use with a 0.035" guidewire. Inner balloon acts as a tool to hold the stent in place while outer balloon is inflated. Allows for controlled and incremental expansion of the CP.

10 OUTER BALLOON INNER BALLOON BIB Placement catheter Specifications (cont d) (MM) (CM) Introducer Size (FR) Shaft Size (FR) (ATM) No BB BB BB BB BB BB BB BB BB BB BB BB BB ` BB076 All catheters have a usable length of 110cm and use a Guidewire CP Sizing Chart Pressure (atm) 12mm 14mm 8 zig 10 zig 15mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm Pressure (atm) 12mm 14mm 8 zig 10 zig 15mm 16mm 18mm 20mm 22mm 24mm 26mm 28mm 30mm Represents the stent Pressure. *This data is based on testing performed using the BIB Placement Catheter.

11 CP Foreshortening Chart ( of Zigs) Inflated After Expansion (PERCENTAGE SHORTENING) cm (2.8%) 2.18cm (0.8%) 2.62cm (4.4%) 3.23cm (3.1%) 3.72cm (1.9%) 4.17cm (3.8%) 4.71cm (6.2%) 5.25cm (5.0%) 5.84cm (4.5%) cm (6.5%) 2.08cm (5.4%) 2.56cm (6.8%) 3.15cm (5.4%) 3.66cm (3.6%) 3.97cm (8.4%) 4.58cm (8.7%) 5.11cm (7.6%) 5.67cm (7.3%) cm (8.5%) 2.02cm (7.9%) 2.51cm (8.6%) 3.10cm (7.0%) 3.54cm (6.6%) 3.94cm (9.2%) 4.50cm (10.3%) 4.98cm (10.0%) 5.55cm (9.2%) 8 ZIG cm (10.6%) 1.43cm (13.7%) 1.98cm (10.1%) 1.89cm (14.0%) 2.45cm (10.7%) 2.38cm (13.3%) 3.00cm (9.8%) 2.88cm (13.5%) 3.48cm (8.2%) 3.20cm (15.6%) 3.84cm (11.4%) 3.71cm (14.5%) 4.42cm (11.9%) 4.21cm (16.1%) 4.91cm (11.2%) 4.70cm (15.1%) 5.43cm (11.2%) 5.20cm (14.9%) cm (20.0%) 1.80cm (17.9%) 2.30cm (16.3%) 2.63cm (20.9%) 2.96cm (21.9%) 3.27cm (24.7%) 3.96cm (21.0%) 4.43cm (20.00%) 4.92cm (19.5%) cm (25.4%) 1.67cm (23.9%) 2.09cm (24.0%) 2.46cm (26.0%) 2.85cm (25.0%) 3.15cm (27.3%) 3.71cm (26.0%) 4.09cm (26.1%) 4.55cm (25.5%) cm (36.4%) 1.46cm (33.8%) 1.91cm (30.3%) 2.07cm (37.9%) 2.27cm (40.1%) 2.83cm (34.9%) 3.33cm (33.5%) 3.72cm (32.8%) 4.14cm (32.3%) cm (18.33%) 3.44m (22.09%) 4.10cm (17.34%) 4.24cm (23.32%) 4.85cm (20.20%) 10 Zig cm (23.68%) 3.24cm (26.75%) 3.71cm (25.11%) 4.00cm (27.58%) 4.39cm (27.87%) cm (33.45%) 3.09cm (30.16%) 3.26cm (34.34%) 3.64cm (34.17%) 4.11cm (32.55%) Visit our web site for more info: NuMED offers Physicians speedy response to catheter design and manufacturing service. The enhanced catheter technology offers Physicians a technically superior option in dealing with clinical needs.

12 NuMED For Children 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 Tower Jr., President Tom McCarty, CFO QS Manager QC/QA Manager Ted Dominy, VP of R&D Nichelle LaFlesh, RA Manager Melissa Thomas, QS Manager Lisa Ramsdell, QC/QA Manager Visit us on the World Wide Web These devices are marketed in the USA under PMA approval. Any customer or distributor outside of the USA will be subject to their individual country s regulations in regards to the importation and sale of these products. 2018, NuMED, Inc., CP STENT BROCHURE Rev. 03/18