Standards Development

Scope

This document is applicable to
– therapy equipment using intraluminal or invasively induced ultrasonic short pressure pulses (e.g. shock waves) through use of a catheter
This document does not apply to
– therapy equipment using extracorporeally or non-invasively induced acoustic pulses
– therapy equipment using other acoustic waveforms like physiotherapy equipment, low intensity ultrasound equipment and HIFU/HITU equipment.
– therapy equipment by which the primary mechanism of action is ablation of the of the lesion due to cavitation bubble collapse are not covered within the scope of this document.
– therapy equipment which do not have an acoustic based mechanism of action (including therapy equipment that utilize mechanical pressure, e.g. iterations of angioplasty technology)
This document specifies
– measurable parameters which are used in the declaration of the acoustic output of intraluminal ultrasonic short pressure pulse equipment

– methods of measurement and characterization of intraluminal ultrasonic short pressure pulse acoustic fields.
NOTE 1 The parameters defined in this document do not – at the time of publication – allow quantitative statements to be made about clinical efficacy and possible hazard. In particular, it is not possible to make a statement about the limits for these effects.
This document has been developed for equipment intended for use in intraluminal ultrasonic short pressure pulse therapy, for example intravascular lithotripsy therapy of calcified lesions found in peripheral artery disease, coronary artery disease, valvular calcium, and other calcified diseases in the body. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689), non-focusing short pressure pulse sources including ballistic pressure pulse sources (as described in IEC 63045), and HIFU/HITU equipment (see IEC 60601-2-62 and IEC TR 62649).
Equipment which do not produce an ultrasonic acoustic field or whose primary mechanism of action is ablation of the of the lesion due to cavitation bubble collapse are not covered within the scope of this document.

Purpose

This document is intended for equipment intended for use in intraluminal ultrasonic short pressure pulse therapy, for example therapy of calcified lesions found in peripheral artery disease, coronary artery disease, valvular calcium, and other calcified diseases in the body. It is not intended to be used for extracorporeal lithotripsy equipment (as described in IEC 61846), physiotherapy equipment using other waveforms (as described in IEC 61689), nonfocusing short pressure pulse sources including ballistic pressure pulse sources (as described in IEC 63045), and HIFU/HITU equipment (see IEC 60601-2-62 and IEC TR 62649).
As the most used application, intravascular lithotripsy (IVL) refers to an interventional procedure to modify calcified plaque in diseased arteries. The mechanism of plaque modification is through use of a catheter with one or more generating sources located within a fluid to apply acoustic pressure pulses (e.g. shock waves) IVL devices vary in design with respect to the energy source used to generate the acoustic pressure pulses. Two examples include:
1) Electrohydraulic: For electrohydraulic generation of acoustic shock waves, the conductive solution (e.g., saline) may be contained and surround electrodes or can be flushed through a tube that surrounds the electrodes.
The calcium modification is achieved by creating acoustic shock waves within the catheter by an electrical discharge across the electrodes. This energy traverses and vaporizes the liquid at a rate faster than the speed of sound thereby creating acoustic shock waves. These shock waves propagate radially outward and modify calcium within blood vessels.
2) Laser: For laser lithotripsy, a laser pulse is transmitted into and absorbed by a fluid within the catheter. This absorption process rapidly heats and vaporizes the fluid thereby generating acoustic shock waves that propagate outward and modify the calcium. The acoustic shock wave intensity is higher if a fluid is chosen that exhibits strong absorption at the laser wavelength that is employed.
Intravascular lithotripsy has been used clinically since 2014 to treat over 400,000 patients globally and is approved for use in over 70 countries, and approximately 60% of the world’s population. Over 381 peer reviewed clinical studies have been published on the clinical safety and efficacy of IVL. In addition, one company which has commercialized IVL had a revenue of ~$730 million USD in 2023 and was acquired for $13.1 billion USD, demonstrating the large market relevance of intravascular lithotripsy and associated intraluminal ultrasonic short