According to the latest market analysis by iData Research, there are over 12,000 intravascular lithotripsy procedures performed in the United States every year. This number is expected to experience incredible growth and double in number by 2026. This growth can be attributed to two main factors: the creation of procedure codes by CMS, and successful lithotripsy device trials.
Shockwave Lithotripsy Procedure
Intravascular lithotripsy is a newer procedure for peripheral cardiovascular space. Extracorporeal lithotripsy has previously been used to break up stones in the kidney, bladder, or ureter, and similar principals were applied to develop a balloon to break up calcium inside the vasculature.
The intravascular lithotripsy (IVL) procedure works through the insertion of a balloon into a calcified lesion, where the balloon is then inflated to standard pressure, filling the vessel. High-voltage pulses are then sent to the balloon from a generator, through a connector cable, to anodes within the balloon. The saline solution inside the balloon experiences brief moments of evaporation, due to the pulses, quickly and substantially increasing the pressure inside the balloon, before condensing back.
These sonic shockwaves break apart calcium without damaging the surrounding tissue, which is able to stretch slightly to accommodate these brief increases in pressure. A single treatment consists of 60 pulses to the lesion area, with each balloon capable of no more than 180 pulses, changing slightly depending on the measurements of the balloon.
Intravascular Lithotripsy Market Analysis
Currently, Shockwave Medical is the only competitor in the intravascular lithotripsy market, having received FDA approval for treatment in the periphery in 2016. The company recently obtained FDA approval for use in coronary treatments in September 2019. Right now, Shockwave Medical is completing its DISRUPT BTK II trial which is expected to provide clinical evidence to allow for FDA approval of commercial use in below the knee (BTK) treatments.
Following the FDA approvals, continued clinical data has also attracted physician confidence generating large growth within the overall lithotripsy market. As the intravascular device deals with calcified lesions, its only competitor is the rapidly growing atherectomy market. However, because lithotripsy balloons are significantly more expensive than most atherectomy devices, the comparative device effectiveness becomes its main feature.
On June 8th, 2020, CMS has created specific codes for the intravascular lithotripsy procedure in the peripheral vasculature. The creation of these codes is expected to bring sizable growth to the market as both inpatient and outpatient facilities expand the use of the device. Formerly, the lithotripsy devices were almost exclusively limited to hospital settings, so the increased funding will greatly improve procedure adoption rates among physicians in the US.
After successfully being used to break up calcium in kidneys, the lithotripsy procedure entered the Peripheral Vascular space. The only competitor currently active on the intravascular lithotripsy market is Shockwave Medical. After receiving their FDA approval in 2016, the company has been successfully running trials of their DISRUPT medical device product line and is expected to soon gain approval for the BTK treatments.
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After the creation of specific codes by CMS, the intravascular lithotripsy procedure is expected to see increased adoption rates by physicians. Coupled with continued clinical evidence supporting the procedure, the overall lithotripsy market is expected to witness an incredible level of growth. Based on the US Peripheral Vascular Market analysis by iData Research, the intravascular lithotripsy market is expected to double in size by 2026 and reach over 24,000 procedures in the United States.