Vasmed Technologies

Designed for smooth movement through long, tight peripheral lesions

Indigo OTW is designed for percutaneous transluminal angioplasty procedures of the femoral, iliac, renal arteries, post deployment and dilation of peripheral vascular stents. Also indicated for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Incorporating the rigidity of over-the-wire design and high-pressure balloon to allow clinicians a device for optimal balloon performance during peripheral interventions.

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Unique Exchangeability Feature

Dual-port hub supports a dedicated channel for the guidewire along the entire catheter, providing the option to exchange with another or remove the catheter entirely while maintaining the wire’s position, or remove the wire entirely and use the port for the injecting of dyes or medication. Providing flexibility to clinicians’ during procedures.
Enhanced Pushability & Navigation

Continuous support of the wire allows the balloon to pass through tight stenoses and complex anatomy without kinking or bending.
High Pressure Dilation

High-pressure, nylon-material made, semi-compliant balloon provides a thicker wall for controlled expansion in longer, tighter lesions during standard vessel dilation and post-stent placement. Controlled expansion up to a Rated Burst Pressure (RPB) of 12 atm.
Superior Visibility

Dual platinum-iridium marker bands offer excellent radiopacity for clear, unambiguous positioning under fluoroscopy

Technical Specifications

Catheter Type	Over-The-Wire
Compliance Type	High Pressure Semi-Compliant
Balloon Folding	Quad Fold
Total Working Length	40cm, 60cm, 80cm, 130cm
Balloon Lengths (in mm)	20 to 100 mm (20, 40, 60,80 and 100 mm)
Balloon Diameters (in mm)	4.50 to 10.00 mm (4.50, 5.00,6.00, 7.00, 8.00, 9.00, 10.00mm)
Balloon Nominal Pressure (N/P)	6 atm: 4.50 to 7.00mm 7 atm: 8.00 to 10.00 mm
Balloon Rated Burst Pressure (RBP)	12 atm
Balloon Crossing Profile:	4.5 mm – less than 0.061” 5.0 mm – less than 0.071” 6.0 mm – less than 0.071” 7.0 mm – less than 0.076” 8.0 mm – less than 0.081” 9.0 mm – less than 0.0915” 10.0 mm – less than 0.0915”

Balloon Material	Nylon
Marker Material	Platinum-Iridium
Radiopaque Markers	Dual Markers
Tip Length	4.5mm
Tip Entry Profile	0.044”
Distal Coating	Hydrophilic
Minimum Introducer Sheath Size	4.50-7.00 mm : 6 Fr 8.00-10.00 mm: 7 Fr
Maximum Guide Wire Compatibility	0.035″ guide wire
Shelf Life	24 months

Compliance Chart

Size	2atm	4atm	6atm	7atm	8atm	10atm	12atm	14atm
4.50mm	3.90	4.25	4.45	4.65	4.75	4.85	4.95	5.10
5.00mm	4.40	4.70	5.00	5.15	5.20	5.30	5.40	5.50
6.00mm	5.30	5.70	6.00	6.20	6.40	6.65	7.00	7.10
7.00mm	6.20	6.65	7.00	7.20	7.40	7.60	7.80	8.10
8.00mm	6.60	7.15	7.80	8.00	8.20	8.30	8.70	9.10
9.00mm	7.65	8.20	8.80	9.00	9.25	9.60	10.00	10.40
10.00mm	8.31	9.13	9.82	10.00	10.32	10.71	11.06	11.47
Nominal Pressure					Rated Burst Pressure

Warnings & Safety

The Indigo PTA Balloon catheters are indicated for the dilatation of lesions in the femoral, iliac, renal arteries or for post deployment dilation of peripheral vascular stents and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Indigo PTA Balloon catheters are intended for use in patients with blockage or narrowing of femoral, iliac or renal arteries with reference vessel diameter of 4.50 mm to 10.00 mm and length ≤ 80 mm, during the Percutaneous Transluminal Angioplasty (PTA) for the purpose of improving blood flow in the femoral, iliac, renal arteries or in patients undergoing the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Possible adverse effects include, but are not limited to, the following:

Artery spasm
Dissection, rupture, perforation or injury of arteries which may require vessel repair
Hypo/hypertension
Ischaemia or acute myocardial infarction
Ventricular fibrillation and flutter
Unstable angina, palpitation
Re-stenosis or total occlusion of the dilated artery
Vascular or stent thrombosis or embolism, distal emboli.
Haemorrhage haematoma and/or haematuria and/or haemoptysis
Pseudoaneurysm
Infection, inflammation and/or fever
Cardiac arrhythmia, extra systoles, bradycardia and tachycardia
Conduction disturbance
Arteriovenous fistula
Allergic reactions to stent materials, contrast medium or other drug reactions
Death
Access site complications
Please also consider the latest medical research findings.

This Indigo catheter is not for use in coronary arteries.

This device is not intended to use for children and pregnant woman.

Do not exceed the pressure rating recommended for this device, balloon rupture may occur if maximum pressure rating is exceeded.
If resistance is felt while either removing the guidewire from the catheter or the catheter from the introducer sheath, stop and consider removing them as a single unit to prevent damage to either the products or the vessel . Applying excessive force to the catheter can result in tip breakage or balloon separation..
Use of the Indigo PTA Balloon catheter must be restricted to thoroughly trained physicians familiar with the technique of Percutaneous Transluminal Angioplasty. Method of use including surgical technique and procedure, is left to the discretion and judgement of the physician. The Indigo PTA Balloon catheter has a protective sheath over the balloon with a stylet running through the center to prevent kinking during shipment and handling, these items must be removed before use.
> Do not use if package is damaged.

> Do not re-sterilize or re-use

> Do not wipe with alcohol.

> Single use only.

> Use a PTA catheter prior to the “ Use Before” date on the package label, preceded by the symbol.

Indigo OTW

Designed for smooth movement through long, tight peripheral lesions

Technical Specifications

Compliance Chart

Warnings & Safety

Indications for use

Intended purpose

Adverse effects

Contra-indications

Warnings