In this study, an easy to use measurement method was developed to quantify the balloon dilatation catheters visibility, thus making them comparable. The visibility of the distal and proximal markers and the balloon (average values of the markers
Keywords balloon dilatation catheter, radiodetectability, visibility
IntroductionCardiovascular diseases are the number one cause of death worldwide. 41% of death is caused by ischaemic heart disease and 35% by stroke [1]. These emergences are caused by stenosis or occlusion of the vessels in the heart or brain [2]. One of the potential medical devices used for the dilatation of the vascular system is the balloon dilatation catheter [3].The balloon dilatation catheter (so called balloon catheter [4][5]) is an intravascular catheter (single or multilumen tube), on which a balloon is located near the distal end (this end is introduced into the body). The hydraulic dilatation of this balloon dilates the narrowed, occluded vessel [3,6,7]. The balloon is monitored in the body using X-ray fluoroscopy [9-10].The current standard for balloon dilatation catheters (ISO 10555-1:2013, ISO 10555-4:2013) and the guide of the U.S. Food and Drug Administration (FDA) specify that the balloon shall be radio-detectable when it is inserted into the body [3,6,11]. The placement of the balloon to the target place in the patient's vasculature is facilitated with radiopaque material. This radiopaque material is typically a metal marker band. It may be placed on the centre of the balloon (single metal marker) or on the ends of the balloon (double metal marker) [12,13].In the standard for general requirements of the intravascular catheters (ISO 10555-1:2013), Part 4 relates to the balloon dilatation catheters, and requests the test method of visibility according to the standard ASTM F640-12 [3,6,14]. It contains standard test methods for determining radiopacity however; it does not specify the type of the medical devices. The guide of the FDA indicates that the radiopaque markers on the balloon should be investigated [11,14,15], but unified measure method is not recommended in the standards and literature. The manufacturer can measure this visibility by different methods, therefore they are not comparable. The methods of the manufacturer are not available. According to the standard (ASTM F640-12) pixel density or optical density are determined by some method.The measured visibility values are not quantified; instead of terms were used for visibility's characterisation, such as: excellent [16], optimal radiopacity [17], optimal visibility [18], and increased radiopacity [19], extremely visible [20].