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Outbyte Driver Updater FREEScan for outdated or missing drivers - takes under a minuteDriver Scan →Outbyte PC Repair FREERepair Windows errors before they cause bigger problemsFix Now →FastWave Medical is developing investigational intravascular lithotripsy (IVL) devices, but its reported clinical milestones do not establish that its technology is approved, commercially available, or likely to capture a share of the market. The often-cited $8.5 billion figure is a historical estimate published by competitor Shockwave Medical in 2022—not a current independent market measurement or a forecast of FastWave’s revenue.
What FastWave Medical is developing
Intravascular lithotripsy uses sonic pressure waves to modify calcified plaque inside arteries. FastWave describes its platforms as treatments for calcific cardiovascular disease. The company’s website says its devices are investigational and limited by U.S. law to investigational use; they should not be described as FDA-approved or routinely available for clinical care. FastWave Medical
Where FastWave’s clinical programs stand
Peripheral program: company-reported IDE approval
FastWave says it received FDA investigational device exemption (IDE) approval in the third quarter of 2026 to begin a peripheral pivotal trial. The company says the trial will evaluate the safety and efficacy of its Artero IVL system in severe calcified peripheral arterial disease. This is a company-reported milestone; an IDE authorizes study of an investigational device and is not marketing approval. FastWave’s Artero program
Coronary program: a forecast, not an approval
FastWave says it anticipates IDE approval to begin a coronary IDE trial in 2027. That is a forecast from the company, not an approval already granted or evidence that the system can be marketed. FastWave’s coronary program
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The available information does not establish independent trial-registry entries or peer-reviewed outcomes for FastWave’s studies. Without those records and results, investors cannot use this evidence to assess clinical performance or compare safety and efficacy with other devices.
Where the $8.5 billion figure comes from
The figure traces to Shockwave Medical’s 2022 Form 10-K, which said the company believed the aggregate addressable market for IVL exceeded $8.5 billion. Shockwave’s 2023 Form 10-K later described the aggregate opportunity in coronary artery disease (CAD) and peripheral artery disease (PAD) as over $8 billion. These are historical estimates from a company selling IVL products, not independent market measurements. Shockwave noted that procedure counts and the prevalence of moderate or severe calcium vary by arterial segment. Shockwave Medical 2022 Form 10-K; Shockwave Medical 2023 Form 10-K
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An addressable-market estimate is not FastWave’s revenue, expected sales, or proof that clinicians will adopt its devices. The retrieved evidence does not establish a current independent estimate for the IVL market in 2026, so the historical figures should not be presented as a current market valuation.
How FastWave compares with an approved IVL competitor
The regulatory distinction is important: FDA records surfaced for this comparison name Shockwave Medical and its Shockwave IVL system, not FastWave. They cannot establish FastWave’s regulatory status. Shockwave’s record is product- and indication-specific; it is not evidence that every IVL device is approved or that FastWave has equivalent evidence. FDA PMA record for Shockwave IVL; FDA PMA record for another Shockwave IVL device
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| Question | FastWave Medical | Shockwave Medical |
|---|---|---|
| Regulatory status in the cited material | Company says its devices are investigational and reports a peripheral IDE approval; coronary IDE approval is anticipated in 2027. | FDA PMA records identify Shockwave IVL products; those records apply to the named Shockwave devices. |
| Clinical evidence described here | Peripheral pivotal trial planned to evaluate Artero safety and efficacy; coronary IDE trial is a future plan. | The cited PMA records establish product authorization, but no comparative outcomes are presented here. |
| Market estimate | No FastWave-specific revenue or market share is established by the cited estimate. | Shockwave’s own historical addressable-market estimates were over $8.5 billion in its 2022 filing and over $8 billion for CAD and PAD in its 2023 filing. |
What the evidence means for an investor
FastWave’s reported milestones indicate that it is advancing a clinical development program, particularly in peripheral arterial disease. They do not yet show whether the devices will demonstrate acceptable outcomes, gain marketing authorization, or achieve commercial adoption. The 2027 coronary IDE target is explicitly prospective.
The $8.5 billion headline figure adds market context but does not establish FastWave’s business prospects. A prospective investor would need to distinguish study authorization from approval, seek independently verifiable trial records and results, and assess whether future regulatory and commercial progress supports the company’s own claims. The VentureBeat article carrying the original headline is labeled contributor content, so its bullish investment framing should not be treated as independent due diligence. VentureBeat contributor article, March 20, 2024
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