By combining unique materials and designs, Loma Vista Medical manufactures high performance composite balloons for BAV and TAVR procedures.
Delivering the ultimate precision, toughness, and speed, the TRUE Dilatation™ Balloon enables accurate, controlled, and reliable dilatations.
The TRUE Dilatation™ balloon catheter is comprised of multiple materials that work together to create
Composite Balloon Cross Section
Over 3,500 TRUE Dilatation Balloon Catheters have been shipped to centers in the US and Europe.
Fabricated from exceptionally strong materials, the TRUE Dilatation Balloon is highly resistant to bursts, ruptures, punctures, and tears. Calcified valves present a high risk to blow molded balloons, with literature showing a failure rate of up to 4-17%.1, 2, 3, 4, 5, 6, 7 Rip-stop fibers help improve safety by preventing the catastrophic failures seen with other balloons, the clinical consequences which can include embolism, inadvertent implant, and surgical intervention. The TRUE Dilatation Balloon Catheter improves the safety and efficacy of BAV and TAVR: over 3,500 units have been shipped without any structural failures. The TRUE Dilatation Balloon delivers the dependability you need.
Watch the demonstration of the puncture resistance of the TRUE Dilatation™ Balloon Catheter to severe
Fiber reinforcement precisely limits the maximum balloon diameter to the labeled size, while allowing conformance to anatomical variation. Other valvuloplasty balloons change diameter by 15% to 40% over their rated pressure range (RBP). The TRUE Dilatation Balloon redefines the category, offering diameter control within 1.5%*.
Lack of precision in balloon inflation could lead to complications such as poor site preparation, poor valve fit, increased risk of paravalvular leak, and ruptured annulus.
Comparison of balloon stretch from 0 to 20 atm. The RBP for balloon catheters shown in the graph is typically
For multiple reasons, large diameter blow molded BAV and TAVI balloons are dimensionally chaotic:
- Steep and often irregular compliance curves.
- Imprecise balloon manufacturing that results in significant variation from balloon-to-balloon. Note that blow molded balloon manufacturers typically have, at a given pressure, a +/-10% diametrical manufacturing tolerance. For a 26 mm balloon, this difference alone is over 5 mm!
- User lack of feedback about pressure – typically no pressure gauge is used and pressure readings are transient. This creates the inability to determine location on a compliance curve, and the inability to assess an intended diameter.
The net result is dimensional chaos in an application that demands precision and repeatability.
By comparison, Loma Vista Medical’s unique composite balloons provide unparalleled dimensional precision and unique repeatability. Net dimensional variations that are up to 30x less than those found with blow molded balloons.
Fast inflation and deflation is critical for device landing, user-control, and the limitation of both rapid pacing and ischemic time.
The TRUE Dilatation™ Balloon Catheter inflates and deflates 2 to 3 times faster than competitors’ balloons*, minimizing ischemia time.
Watch the demonstration of fast inflation of the 24 mm TRUE Dilatation™ Balloon Catheter below: