Vasmed Technologies

Engineered for Uncompromised Performance
in Complex Lesions

Hightrack is a state-of-art rapid exchange (RX) balloon catheter specifically engineered for the challenges of ost-stent dilation and the treatment of highly calcified lesions. It is designed to provide dinicians with superior control, deliverability and the high-pressure force needed to optimize outcomes in complex percutaneous coronary interventions (PCI)

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Exceptional Deliverability

A combination of a low-profile tip, advanced shaft technology, and hydrophilic coating allows for smooth navigation through tortuous anatomy and previously stented segments.
Enhanced Procedural Control

The unique stainless steel hypotube construction ensures outstanding torque response, pushability, and trackability, giving the operator precise control from the guide catheter to the lesion.
Ultra-High Pressure Dilation

The robust, non-compliant nylon balloon material provides the confidence to dilate resistant, calcified lesions with controlled, predictable expansion up to a Rated Burst Pressure (RBP) of 20 atm.
Superior Visibility

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

Technical Specifications

Catheter Type	Rapid Exchange RX
Compliance Type	Non-Compliant
Balloon Folding	Tri-Fold
Total Working Length	142cm
Balloon Lengths (in mm)	10 mm – 30 mm (10, 12, 14, 15, 16, 18, 20, 23, 25 & 30mm)
Balloon Diameters (in mm)	2.5 mm – 4.0 mm (2.50, 2.75, 3.00, 3.25, 3.50, 3.75, 4.00 mm)
Distal Shaft Diameter	2.6 Fr
Proximal Shaft Diameter	1.9 Fr
Balloon Nominal Pressure (N/P)	12 atm
Balloon Rated Burst Pressure (RBP)	20 atm
Balloon Crossing Profile:	2.5 mm-2.75 mm ≤ 0.0315” (≤0.80mm) 3.0 mm ≤ 0.033” (≤0.84mm) 3.25 mm ≤ 0.0345” (≤0.88mm) 3.5 mm -4.0 mm ≤ 0.036” (≤0.91mm)

Balloon Material	Nylon
Marker Material	Platinum-Iridium
Radiopaque Markers	Dual Markers
Tip Length	4mm
Tip Entry Profile	0.019”
Distal Coating	Hydrophilic
Minimum Guiding Catheter ID	5 Fr
Maximum Guide Wire Compatibility	0.014”
Inflation Time	<10 sec
Deflation Time	<25 sec
Shelf Life	36 months

Compliance Chart

This chart illustrates the non-compliant nature of the Hightrack balloon, showing minimal diameter growth from Nominal to Rated Burst Pressure, ensuring predictable and controlled dilation

Size	4atm	6atm	8atm	10atm	12atm	14atm	16atm	18atm	20atm	22atm
2.50mm	2.17	2.32	2.39	2.47	2.50	2.54	2.57	2.59	2.62	2.65
2.75mm	2.38	2.49	2.59	2.68	2.75	2.77	2.80	2.83	2.85	2.88
3.00mm	2.62	2.77	2.88	2.96	3.02	3.06	3.09	3.13	3.17	3.22
3.25mm	2.80	2.98	3.11	3.19	3.25	3.32	3.35	3.40	3.46	3.60
3.50mm	3.02	3.22	3.34	3.42	3.48	3.53	3.59	3.64	3.70	3.74
3.75mm	3.20	3.41	3.54	3.65	3.74	3.79	3.85	3.90	3.97	4.13
4.00mm	3.57	3.74	3.84	3.92	3.98	4.04	4.10	4.15	4.22	4.23
Nominal Pressure						Rated Burst Pressure

Warnings & Safety

The HighTrack Balloon catheters are indicated as post dilatation catheters for the post-delivery expansion of balloon expandable stents (Bare Metal & Drug Eluting Stents) during the PCI procedures.

The HighTrack Balloon catheters are intended for use in patients with the symptomatic ischemic heart disease due to discrete denovo or restenotic lesions with reference vessel diameter of 2.50 mm to 4.00mm and length ≤ 30mm, for the purpose of post-delivery expansion of balloon expandable stents during the Percutaneous Transluminal Coronary.

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.

Patients who are unsuitable for bypass surgery and/or PTCA
Patients who are unsuitable for treatment with the necessary medication (eg. anticoagulants, antiplatelet therapy).
Imminent thrombus formation and alteration of flow after myocardial infarction.
Evidence of existing thrombus.
Severe allergic reactions to contrast medium
Treatment of an unprotected left main coronary artery lesion, of proximal lesions, or of significant vessel tortuosity which prohibits guide wire access and sufficient guiding catheter support
Patients in whom insufficient predilatation of the lesion is possible
Spasm of the arteries in absence of stenosis or previously diagnosed severe coronary-arterial or arterial spasms
Please also consider the latest medical research findings.
This device is not intended to use for children and pregnant women.

NOT use the balloon catheter if the sterile package is damaged or after the sterility expiry date.
Balloon expansion must always be performed under high quality fluoroscopic control.
This device is provided sterile and is intended for single patient use only. DO NOT re-sterilize. DO NOT re-use.
This device should only be used by trained physicians experienced in Percutanious Transluminal Coronary Angioplasty (PTCA) and coronary stenting techniques.
Always open the haemostatic valve fully before feeding the catheter through it.
If resistance is met during advancement or manipulation of the catheter system, determine the cause of the resistance before proceeding.
The High Track Rapid Exchange PTCA Balloon Catheter Low Compliant High Burst Pressure is not designed for use in CTO or >90% occlusions due to the large profile of the balloon.
Never forcibly advance the balloon catheter.
Use appropriate balloon inflation medium – do not use any gaseous medium or air to inflate the balloon. Do not exceed the rated balloon burst pressures. Refer to compliance chart for guidance.
Should the risk of embolisation necessitate removal of the catheter prior to expansion, the guiding catheter and PTCA catheter should be removed as one unit.
If the balloon gets caught and is unable to be removed by normal means, it should be removed via cardiac surgery.
A cardiac surgery team must always be on stand-by during stent implantation procedures so that emergency coronary bypass surgery can be quickly performed in the event of potential injuries or life threatening complications.
After use, this product may be contaminated and should be disposed using standard hospital practice.
The device is not intended to use for children and pregnant women without prior consultation of pediatrician / obstetrician.

High Track

Engineered for Uncompromised Performancein Complex Lesions

Technical Specifications

Compliance Chart

Warnings & Safety

Indications for use

Intended purpose

Adverse effects

Contra-indications

Warnings

Engineered for Uncompromised Performance
in Complex Lesions