Designed for precise placement and superior clinical outcomes

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Polaris – Semi Compliant PTCA Balloon Dilatation Catheter

Crossability

Reduced tip & balloon profile

Pushability

Improved Tensile resistanc

Trackability

Shorter & redesigned tip

Low Compliance < 8%

Proprietary Hypotube for Smooth navigation at Target Lesion.Above features enable outstanding eciency and performance on elder & diabetic patients as well as those with chronic total occlusions (CTO) or angulated, calcied & tight lesions.

01

Super Combination between Hypotube & Distal shaft to enhance performance of Trackability & Pushability in tortuous path (this is to use below schematic diagram of catheter)

02

Low profile tapered tip enhance entry into tight calcified lesion (use tip picture)

03

A very ne Hydrophilic coating is applied on distal shaft for smooth transition (to use picture)

04

A uniform expansion of balloon & precise placement of markers bands (Inside balloon shoulder) for accurate positioning at target site (use balloon expansion picture)

Intended Use

Polaris PTCA Semi Compliant Dilatation Catheter is indicated for:
Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.

PTCA Specification

Generic Name PTCA Semi-Compliant Rapid Exchange Dilatation Catheter
Product Name Polaris PTCA Semi-Compliant Rapid Exchange Dilatation Catheter
Available lengths (mm) 6, 8, 10, 12, 15, 20, 25, 30, 33, 38, 41
Available Diameters (mm) 1.25, 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50
Balloon Material Polyn®
Catheter Design Rapid Exchange delivery system
Usable Shaft Length (cm) 140
Rapid Exchange length 25cm
Guide wire Compatibility 0.014”
Tip entry pro le 0.017” (0.43mm)
Sheath Compatibility Minimum of 5F
Guiding catheter Compatibility Minimum of 5F
Balloon Fold 3 –fold memory
Radio opaque markers Zero pro le
Markers on the proximal shaft 90cm and 100cm
Hydrophilic Coating On the distal shaft
Shaft Diameter Proximal 1.95F, Distal 2.70F
Balloon Properties Nominal Pressure (NP): 8 atm Rated Burst Pressure (RBP): 14 atm & 16 atm depending on balloon size

Compliance Chart

Pressure Balloon Diameter (mm)
atm 1.25 1.5 2 2.25 2.5 2.75 3 3.25 3.25 3.5 3.75 4 4.5
2 1 1.21 1.71 1.96 2.21 2.46 2.71 2.96 3.21 3.46 3.71 4.16
4 1.18 1.31 1.81 2.06 2.31 2.56 2.81 3.06 3.31 3.56 3.81 4.28
6 1.21 1.41 1.01 2.16 2.41 2.66 2.91 3.16 3.41 3.66 3.91 4.4
8 1.25 1.5 2 2.25 2.5 2.75 3 3.25 3.5 3.75 4 4.5
10 1.29 1.54 2.06 2.31 2.56 2.81 3.06 3.31 3.56 3.78 4.08 4.58
12 1.33 1.58 2.12 2.37 2.62 2.87 3.12 3.37 3.62 3.89 4.16 4.66
14 1.36 1.62 2.18 2.43 2.68 2.93 3.18 3.43 3.68* 3.96* 4.24* 4.74
16 1.39 1.66 2.24 2.49 2.74 2.99 3.24 3.49 3.74 4.02 4.3 4.8
18 1.41 1.69 2.27 2.52 2.78 3.03 3.29 3.55 3.8 4.08 4.36 4.86
20 1.43 1.72 2.3 2.55 2.82 3.07 3.34 3.6 3.86 4.14 4.42 4.92

Note: Grey background: NP (Nominal Pressure), Blue background: RBP (Rated Burst Pressure) Measured at 37.5C, tolerance +/-0.1mm between nominal & RBP for balloon ≤ 41mm* RBP = 14 for diameter 3.50, 3.75 with length>35mm and diameter 4.00 with length>30mm

Polaris – PTCA Dilatation Balloon Catheter (Non-Compliant)

Crossability

Reduced tip & balloon profile

Pushability

Improved Tensile resistanc

Trackability

Shorter & redesigned tip

Low Compliance < 8%

Proprietary Hypotube for Smooth navigation at Target Lesion Above features enable outstanding efficiency and performance on elder & diabetic patients as well as those with chronic total occlusions (CTO) or angulated, calcified & tight lesions.

01

Super Combination between Hypotube & Distal shaft to enhance performance of Trackability & Pushability in tortuous path (this is to use below schematic diagram of catheter)

02

Pebax medical grade Soft tip is used to facilate advancement of catheter in tight lesion (use tip picture)

03

Low tip entry prole for easy cross & re-cross (use this feature along with above)

04

A very ne Hydrophilic coating is applied on distal shaft for smooth transition (to use picture)

05

A uniform expansion of balloon & precise placement of markers bands (Inside balloon shoulder) for accurate positioning at target site (use balloon expansion picture)

06

Proprietary balloon Mfg. process is established for smooth, uniform & control expansion to minimize inammation during expansion at high pressure in stenotic lesion. Nylon material is used to provide a non compliance at high pressure (used balloon expansion picture).

Intended Use

Polaris – PTCA Dilatation Balloon Catheter (Non-Compliant) is indicated for:
Intended to dilate a stenotic portion of a native coronary artery or a bypass graft stenosis for the purpose of improving myocardial perfusion and to be used for post-dilatation of stents.

Specications Polaris PTCA Non-Compliant Dilatation Catheter

Generic Name PTCA Non-Compliant Dilatation Catheter
Product Name Polaris PTCA Semi-Compliant Rapid Exchange Dilatation Catheter
Available lengths (mm) 6, 8, 10, 12, 15, 20, 25, 30, 33, 38
Available Diameters (mm) 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00, 4.50,
Balloon Material Polyn®
Catheter Design Rapid Exchange delivery system
Usable Shaft Length (cm) 140
Rapid Exchange length 25cm
Guide wire Compatibility 0.014”
Tip entry profile 0.017” (0.43mm)
Sheath Compatibility Minimum of 5F
Guiding catheter Compatibility Minimum of 5F
Balloon Fold 3 –fold memory
Radio opaque markers Zero profile
Markers on the proximal shaft 90cm and 100cm
Hydrophilic Coating On the distal shaft
Shaft Diameter Proximal 1.95F, Distal 2.70F
Balloon Properties Nominal Pressure (NP): 8 atm Rated Burst Pressure (RBP): 14 atm & 16 atm depending on balloon size

Compliance Chart

Pressure Balloon Diameter (mm)
atm 1.5 2 2.5 2.75 3 3.5 4 4.5
6 1.33 1.85 2.32 2.5 2.77 3.24 3.67 4.13
7 1.36 1.88 2.36 2.55 2.81 3.29 3.72 4.21
8 1.38 1.91 2.39 2.60 2.85 3.33 3.78 4.27
9 1.4 1.94 2.42 2.64 2.88 3.37 3.83 4.33
10 1.45 1.96 2.44 2.68 2.91 3.4 3.87 4.38
11 1.47 1.99 2.47 2.72 2.95 3.44 3.92 4.43
12 1.49 2.01 2.5 2.75 2.98 3.48 3.98 4.48
13 1.51 2.03 2.52 2.76 3.01 3.51 4.01 4.53
14 1.53 2.05 2.54 2.77 3.03 3.54 4.04 4.57
15 1.55 2.07 2.56 2.78 3.06 3.56 4.08 4.61
16 1.56 2.08 2.57 2.79 3.08 3.58 4.11 4.64
17 1.58 2.1 2.59 2.81 3.09 3.6 4.13 4.67
18 1.59 2.11 2.6 2.83 3.11 3.62 4.15 4.69
19 1.61 2.13 2.61 2.85 3.12 3.64 4.17 4.72
20 1.62 2.14 2.62 2.86 3.13 3.66 4.19 4.74
21 1.64 2.15 2.64 2.88 3.15 3.67 4.21 4.76
22 1.65 2.16 2.65 2.89 3.16 3.68 4.23 4.79
Note: Grey background: NP (Nominal Pressure), Blue background: RBP (Rated Burst Pressure) Measured at 37.5C
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