General Questions
What is the ClearPath Nasal Balloon System?
The ClearPath Nasal Balloon System is a minimally invasive device designed to provide precise nasal dilation, helping surgeons address nasal obstructions and improve patient outcomes.
How does the ClearPath system differ from traditional nasal surgery?
ClearPath minimizes the need for incisions and nasal packing, reduces surgical time, and offers faster patient recovery compared to traditional methods.
What are the primary indications for using ClearPath?
ClearPath is intended for patients aged 17 and older to address nasal obstructions by dilating the inferior turbinate and nasal septum.
Is ClearPath FDA-cleared?
Yes, ClearPath is FDA-cleared for use in nasal surgeries.
What conditions can ClearPath help treat?
ClearPath is effective for treating nasal obstructions, septal deviations, turbinate hypertrophy, and conditions requiring increased nasal space for endoscopic procedures.
Product Components & Use
What are the main components of the ClearPath system?
The system consists of a reusable stainless-steel spatula and a single-use non-elastic balloon catheter.
How is the balloon inflated during the procedure?
The balloon is inflated using sterile water or saline through a compatible inflation device.
Can ClearPath be used with a guidewire?
Yes, the balloon catheter has a lumen for optional guidewire use to aid placement.
What is the maximum inflation pressure for the balloon?
The maximum inflation pressure varies by balloon size, with a standard maximum of 10-12 atm depending on the diameter.
How is ClearPath inserted and positioned?
Under endoscopic visualization, the catheter is guided along the nasal floor and septum to the target dilation site before inflation.
Cleaning & Sterilization
How should the reusable spatula be cleaned?
The spatula should be cleaned using an enzymatic cleaning solution, followed by ultrasonic cleaning and thorough rinsing.
How should the spatula be sterilized?
Steam sterilization using a pre-vacuum autoclave cycle at 132°C/270°F for a minimum of 4 minutes is recommended.
Can the balloon catheter be reused?
No, the balloon catheter is intended for single-use only and must be disposed of after each procedure.
What precautions should be taken during cleaning?
Use non-metallic brushes to clean lumens and avoid caustic cleaners that can corrode the stainless-steel instruments.
Safety & Compatibility
Are there any contraindications for using ClearPath?
Yes, it is contraindicated in cases of gross anatomical abnormalities or congenital craniofacial deformities.
What are the risks associated with using the ClearPath system?
Risks include potential tissue trauma if the balloon is improperly positioned or inflated beyond the recommended pressure.
Is ClearPath compatible with standard surgical tools?
Yes, ClearPath is compatible with standard guidewires, cannulas, and endoscopic equipment commonly used in nasal procedures
Can the device be tested before use?
No, pre-inflation or testing of the balloon is not recommended as it may compromise performance.
Sales & Support
How can I place an order for the ClearPath system?
Orders can be placed by contacting Intuit Medical Products through info@clearpathnasal.com
What are your standard payment terms?
Payment terms are Net 30, with charges applied upon product delivery.
How can I request a demonstration of the product?
Contact a local representative through the form on the website or by emailing info@clearpathnasal.com
Is there a warranty for the reusable spatula?
Yes, the spatula is guaranteed for materials, function, and workmanship when used according to the provided instructions.
Can I return a defective product?
Yes, defective products can be returned in their original packaging after obtaining a return authorization from customer service.
How long does it take to perform a procedure using ClearPath?
The ClearPath system typically reduces surgical time compared to traditional methods, though the exact duration varies by case.
Where can I find more detailed instructions for use?
Detailed instructions for use, cleaning, and sterilization can be found in the product IFUs or online at www.clearpathnasal.com/instructions-for-use
