Balloon Pressures
Shape and size clearly influence what a balloon is useful for, but its mechanical properties often matter just as much. Pressure is the first of these to consider, because many procedures depend on expanding a balloon in a controlled way for the intervention to work. Two values define the pressure range for a given application: the nominal pressure and the rated burst pressure.
Nominal pressure is the pressure typically applied to achieve a therapeutic goal. If a plaque-filled vessel needs to be dilated to a specific diameter, the nominal pressure is what accomplishes that in most cases, often around 15 atmospheres for a given application. The rated burst pressure, sometimes called the minimum burst strength, describes the range of pressure that can be applied safely while attempting the task.
The two values are derived differently. Nominal pressure comes from applying prototype balloons in the clinical setting. Rated burst pressure is a statistical calculation used to estimate the lowest pressure at which a balloon can be expected to perform. Because it is not practical to test every manufactured balloon before it is used, the rated burst pressure provides a way to estimate the limits of a population of balloons under typical operating conditions.
Most modern balloons fall into four pressure classes. High-pressure balloons can reach rated burst pressures as high as 40 atmospheres, roughly 30,000 mmHg. They are usually reinforced with a braid-like structure that lets them hold that pressure without failing, which makes them useful for dilating heavily calcified vessels that will not open at lower pressures. Commercial examples include the BD Conquest, BD Atlas, and Boston Scientific Athletis devices.
Moderate-pressure balloons, such as the Boston Scientific Mustang, generate pressures between roughly 25 and 34 atmospheres, about 19,000 to 25,000 mmHg. They reach those levels through multiple layers of balloon material, nesting balloons within balloons, or using especially thick material so the balloon does not cavitate or fail.
Standard-pressure balloons carry rated burst pressures between 12 and 16 atmospheres, roughly 9,000 to 12,000 mmHg. They offer well-defined profiles and navigate tortuous vessel anatomy more easily than moderate and high-pressure balloons. As the name suggests, this class has been in use since the earliest angioplasty procedures.
Low-pressure balloons operate below 12 atmospheres. They are used for clinical problems that require the balloon to conform to very specific anatomy, where the goal is to reach a particular volume or diameter rather than to apply high force. The VDC balloon from Poba Medical is one example of a low-pressure balloon.