
Something Doesn’t Add Up in the Cath Lab
Three strategics just committed $13 billion to IVL. None of them own the imaging that makes IVL work. That's not an oversight. That's a gap waiting to be filled.
Juan Vegarra
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I've spent 35 years investing in technology. The pattern that generates returns is always the same: a large market, a fundamental gap, and a gap so familiar that the people living with it have stopped seeing it.
I think I'm looking at one right now.
$13 Billion Says IVL Is Real
Johnson & Johnson paid $13.1 billion for Shockwave Medical. Shockwave has treated more than a million patients and is on track to become J&J MedTech's thirteenth billion-dollar platform.
Boston Scientific launched SEISMIQ and enrolled a coronary IDE trial. They're building an IVL franchise from scratch, four years behind a competitor they're betting they can catch.
And this week — April 13 — Stryker signed a definitive agreement to acquire Amplitude Vascular Systems. AVS's Pulse IVL platform uses pulsed CO₂ pressure waves delivered across the entire balloon length at ~15 pulses per second, no emitter required. A next-generation architecture. Not yet FDA-cleared. Stryker wrote that check before the product reached the market, explicitly to build a comprehensive peripheral vascular platform — their second major peripheral acquisition in 14 months, following the $4.9B Inari Medical deal in February 2025.
Three strategics. $13B+ in disclosed value alone. 24 months. The debate over whether IVL matters is over.
Here's What They Don't Own
IVL is a treatment. It cracks calcium. But before you deploy an IVL balloon, you need to know where the calcium is, how thick it runs, and whether the lesion qualifies for lithotripsy versus standard dilation. After IVL, you need confirmation — did the calcium fracture? Did the stent expand? That information doesn't come from fluoroscopy. It comes from intravascular imaging.
Both IVUS and OCT have validated scoring systems — the IVUS CaLADeN and OCT Calcium Volume Index — that formally gate the IVL decision. The 2025 ACC/AHA and 2024 ESC guidelines elevated imaging to Class I, Level A for complex PCI. The ECLIPSE trial, 2,005 patients across 104 U.S. sites, found imaging guidance cut major adverse events by 26%. The evidence is categorical.
Imaging is used in fewer than 15% of U.S. PCI cases. Japan runs at 75–85%. Same devices. Same evidence. The gap isn't clinical — it's a workflow problem that a better device could solve.
So ask the question: J&J owns Shockwave — coronary and peripheral IVL treatment. BSX has SEISMIQ — coronary IVL treatment. Stryker just acquired Amplitude — peripheral IVL treatment, specifically PAD.
The split is instructive. J&J is building the coronary IVL franchise. Stryker is explicitly building the peripheral vascular platform. Two different anatomies, two different clinical workflows — and the same imaging gap in both.
Which of them owns the imaging?
None of them.
Boston Scientific dominates the intravascular imaging market — their IVUS platform is the most widely installed system across U.S. and global catheterization laboratories. Abbott's ILUMIEN leads OCT. But here's the problem for all of them: neither has a forward-view platform. Neither operates below 1.5mm. And neither is designed for integration with IVL as a combined workflow device.
They own the treatment. They don't own the eyes. In a market heading toward $1.5–1.8 billion by 2033 at 15–18% CAGR, the imaging workflow isn't a peripheral accessory. It's the clinical gating mechanism. That's a competitive vulnerability — and in MedTech, those get acquired.
Why the Gap Hasn't Closed
The catheter exchange is structural. To image with current IVUS or OCT, you remove the treatment catheter, advance the imaging catheter, run the pullback, remove it, re-advance for treatment. In a complex IVL case that exchange runs twice. Each one costs procedure time, contrast, and complexity in patients who can't easily spare it.
Below that is a physics problem. Conventional imaging rotates behind the catheter tip — it captures cross-sections, not what's ahead. CMOS chip-based systems can't miniaturize below ~1.5mm without fundamental signal loss. Forward-view imaging at coronary and peripheral catheter scales hasn't existed. That's not a market failure. That's unsolved physics.
What Would Close It
If you designed this from scratch: forward-view, not side-viewing pullback. OCT-level resolution for calcium measurement. Under 1mm, so it doesn't require removing the treatment catheter. Useful in coronary, peripheral, and neurovascular — so the economics justify the R&D.
Piezo-actuated, not chip-based. A single optical fiber driven at the distal tip, illuminated by RGB lasers in a resonant spiral scan, generates forward-view imaging at the catheter tip itself. Peer-reviewed scanning fiber angioscopy research has demonstrated ~12-micron resolution at 30 Hz video rates in human vascular anatomy. Integrate OCT into the same fiber and you have simultaneous forward view and cross-sectional calcium measurement — without a device exchange — at 1mm.
That's what VerAvanti is building. PRISM IV — our Scanning Fiber Endoscope — is pre-commercial and in 510(k) clearance. Architecture validated in proof-of-concept. A 2025 retrospective of 261 IVL cases found imaging was used for catheter sizing and pulse delivery in every procedurally successful case where it was available. The workflow integration already happens where the form factor allows. The device at the right size hasn't existed.
The Market Read
The IVL market is growing fast in both coronary and peripheral. J&J is scaling coronary IVL globally. Stryker is now stacking peripheral vascular acquisitions — Inari for thrombectomy, Amplitude for IVL — building a platform play in PAD. These are not incremental moves. They are franchise bets. And the forward-view imaging gap exists in both anatomies: peripheral vessels are longer, more tortuous, and in many cases more challenging to image than coronary. A 1mm forward-view platform with integrated OCT is as relevant to Stryker's peripheral build as it is to J&J's coronary franchise.
A 1mm forward-view platform with integrated OCT has recurring single-use catheter revenue per procedure — the same model that built IVUS and OCT into durable hundred-million-dollar franchises. The addressable market spans coronary, peripheral, and neurovascular. The strategic case for any of the three IVL leaders writes itself: transform their treatment investment into an image-guided, optimized procedure.
Three strategics. $13B in treatment. No one owns the imaging. That is not a stable equilibrium.
My father had quadruple bypass surgery. I remember the waiting room. I know there has to be a better way — and for the first time, the physics allow it.
The IVL market is here. The imaging gap is quantified. The guidelines have spoken. The question is who fills the gap, and when.
If you're in MedTech strategy, cardiovascular investing, or corporate development — I'd genuinely love to compare notes.

