Surgeries & Interventions

Abbott Enters Burgeoning IVL Segment

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.

Get twice-weekly insights on the biggest stories shaping cardiology.

You might also like

Cardiac Imaging June 16, 2025

Beyond Hardware: Is AI the Answer to Making Cardiac Imaging more Accessible? June 16, 2025

Sponsored by Philips Healthcare Cardiac imaging has traditionally improved through hardware advances, enabling the speed needed for high-quality images. However, hardware is rapidly reaching its physical limitations in suppressing cardiac motion and represents a large financial investment. Today, software and AI are driving the next leap in cardiac image quality and motion control – offering […]

Cardiology Pharmaceuticals June 12, 2025

FDA Approves a New BP Triple Polypill June 12, 2025

Bringing a more effective BP therapy to the U.S. market, the FDA approved George Medicines’ triple therapy polypill called Widaplik for patients with hypertension, making it the first of its kind to go to market in the U.S. Widaplik’s approval stems from two studies, including one comparing the polypill against placebo as an initial treatment […]

Cardiology Pharmaceuticals June 12, 2025

Pharmacologic Preconditioning to Improve Outcomes in Patients Undergoing Cardiac Surgery  June 12, 2025

The majority of patients undergoing cardiac surgery, especially those on cardiopulmonary bypass (CPB), experience post-operative complications such as new-onset atrial fibrillation (POAF) and acute kidney injury (AKI), largely driven by oxidative stress and inflammation.   Several approaches have been explored to reduce complications following cardiac surgery, however, a clinically meaningful impact has yet to be realized.  […]

You might also like..

Select All

You're signed up!

It's great to have you as a reader. Check your inbox for a welcome email.

-- The Cardiac Wire Team

You're all set!