Balloon Catheter
Innovation you can trust when performance matters
Precision in Valvular Dilation
Setting the standard for valve preparation with industry-leading radial strength and control.
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Precision
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Speed
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Innovation
The KardiaPSIâ„¢ Balloon Catheter platform is specifically designed for the high-pressure demands of Balloon Aortic Valvuloplasty. By combining non-compliant balloon technology with a high-performance catheter, we provide clinicians with the power and control required to treat stenotic aortic valves.
Attributes & Clinical Benefits
Extreme Non-Compliance
Maintains its engineered diameter even at high pressures, ensuring the focal force is delivered exactly where intended during valvuloplasty, and not beyond.
Short Working Length and Tight Shoulders
Put the pressure exactly where you want it, minimizing the risk of interaction with neighboring structures.
Fast Inflation/Deflation
High-flow lumen design allows for rapid inflation and deflation, critical for minimizing the duration of cardiac output interruption during rapid pacing, and all with one indeflator.
Excellent Trackability and Stability
The double braided shaft is engineered to provide the pushability, stability, and torque needed to cross and position the balloon where needed, remaining in place during rapid pacing and inflation.
Millimetric Precision
Balloon diameters spanning from 19 to 29mm, in 1 mm intervals, allow for very precise size selection to match the anatomic need. Radiopaque marker bands provide clear visualization under fluoroscopy, ensuring accurate longitudinal placement within the valve.
Flat Curve. High Confidence.
KardiaPSIâ„¢ Balloon Catheter Compliance CurvePressure vs. Diameter
Technical Note: The KardiaPSIâ„¢ Balloon Catheter is a non-compliant balloon. The chart illustrates diameter stability from Nominal Pressure (4atm) to Rated Burst Pressure (24atm).
(Data on file)
KardiaPSIâ„¢ Balloon Catheter Product Specifications
| Balloon Diameter |
Balloon Working Length |
Rated Burst Pressure (RBP) |
Catheter Shaft Working Length |
Recommended Introducer |
|---|---|---|---|---|
| 19-29 mm (1 millimeter increments) |
25 (mm) | 24 atm | 120 cm | 16 Fr |
Frequently Asked Questions
The KardiaPSIâ„¢ Balloon Catheter is indicated for Balloon Aortic Valvuloplasty (BAV) to treat stenotic aortic valves by improving leaflet mobility and increasing the effective orifice area (EOA).
The KardiaPSI™ Balloon Catheter is currently validated for adult populations. Use in pediatric patients should be at the discretion of the clinician based on the specific anatomical requirements and sizing available in our matrix (19mm–29mm).
Yes, the KardiaPSIâ„¢ Balloon Catheter may be used for the pre-dilation phase of TAVR procedures to prepare calcified leaflets and therefore facilitate optimal expansion of the prosthetic valve frame.
The system is optimized for use with standard 0.035" guidewires to provide the necessary support for navigating the aortic arch and maintaining stability during inflation.
While indicated for general aortic stenosis, its non-compliant material and 6-fold re-wrap design may make it particularly effective for the asymmetric calcification often found in bicuspid anatomy, though it has not yet been validated in that specific scenario.
The KardiaPSIâ„¢ Balloon Catheter is engineered from a proprietary combination of multiple layers of polymers and reinforced fibers arranged in a manner that provides extreme non-compliant strength while maintaining a thin delivery profile.
Our pleat and fold pattern and processes ensure the balloon collapses symmetrically upon deflation. This prevents "pancaking" and results in a significantly lower secondary profile for easier withdrawal through the sheath.
Yes, the entire KardiaPSIâ„¢ Balloon Catheter system is manufactured without the use of DEHP or natural rubber latex to ensure patient safety and biocompatibility.
No, there are no coatings on the catheter shaft itself.
Two highly radiopaque marker bands are gluedonto the inner shaft, identifying the working length and shoulders of the balloon to ensure precise longitudinal placement within the annulus.
All sizes have a RBP of 24 atmospheres.
Non-compliance ensures that the balloon diameter stays consistent from 4 to 24 atm. This provides predictable sizing and prevents over-expansion in the LVOT or the aortic root.
Optimized large-lumen technology allows for complete deflation of the 29mm balloon in under 5.25 seconds using an 80/20 saline/contrast mix, with smaller balloon achieving complete deflation significantly faster than this. This is critical to reduce rapid pacing times.
The device is validated for a 1-year shelf life when stored in standard clinical environments, ensuring reliability for your lab's inventory. 2-year shelf-life validation is in process.
Each device is supplied sterile and non-pyrogenic in a Tyvek pouch, designed for easy aseptic transfer into the sterile field of the Cath Lab.
The KardiaPSIâ„¢ Balloon Catheter is validated for a 12-month shelf life from the date of sterilization when stored in a cool, dry environment.
Pricing and contract inquiries can be sent via the Contact Us page on our website.
The KardiaPSIâ„¢ Balloon Catheter is currently cleared for sale and distribution only in the U.S., with a projected commercial launch in mid-2026. For information outside the U.S., please Contact Us for the specific regulatory status in your region.
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