Intravascular lithotripsy (IVL) may have once been synonymous with Shockwave Medical, but it’s now rapidly becoming one of the hottest segments in interventional cardiology, spurred on by Abbott’s new IVL Investigational Device Exemption (IDE) from the FDA.
- IVL is a minimally invasive medical catheter-based procedure that treats calcified plaque in blood vessels.
- IVL works by inflating a balloon inside the calcified blood vessel and generating shock waves to fracture the calcium, which is then removed for improved blood flow.
- Shockwave Medical was the first company to develop and commercialize IVL, applying it to PAD in 2016 and gaining calcified coronary artery approval in 2021.
Abbott’s new IVL IDE was two years in the making following its $890M acquisition of Cardiovascular Systems in 2023 that gave the medtech giant an entry into the IVL arena.
- With the FDA nod, Abbott can now evaluate the IVL system in treating severe calcification in coronary arteries prior to stenting.
- For its first CAD trial – TECTONIC – Abbott plans to enroll up to 335 patients at 47 U.S. sites.
But the incumbent competition is already serious, as Shockwave was recently acquired by Johnson & Johnson for $13B and now has the medtech titan’s financial backing to accelerate marketing and commercialization.
- Following the trend, Boston Scientific acquired IVL developer Bolt Medical for $443M upfront this past January in an attempt to bolster its trajectory to market.
That’s a huge amount of money being thrown at IVL, which speaks volumes to the industry’s faith in its potential for removing calcified plaque – but it’s not just a technology for the big leagues…
- Smaller competitors like FastWave Medical ($31M in total funding), Vantis Vascular ($49M), and Amplitude Vascular ($67.3M) are still trying to make waves in the IVL segment too.
- Notably, FastWave’s FIH trial was successful last year, while Amplitude’s Pulse IVL system secured its IDE approval in June of 2024.
The Takeaway
Shockwave might have a decade head start, but it appears that the cardio-medtech industry has woken up to the potential of IVL, and this much competition is likely to breed innovation that benefits patients.
