Intravascular lithotripsy (IVL) has rapidly emerged as one of the most transformative frontiers in cardiovascular intervention, but existing systems still face limitations in deliverability, efficiency, and clinical versatility. FastWave Medical, a rising force in the medtech landscape and a 2025 Fierce 15 honoree, is challenging that status quo with a dual-platform IVL approach designed to redefine calcium modification therapy.

To learn more about the company’s technology, intellectual property strategy, and commercialization roadmap, MedTech Spectrum spoke with Tristan Tieso, Chief Operating Officer, and Sukanya Iyer, Head of Technology at FastWave Medical. With decades of combined experience at leading device companies and deep expertise in engineering and product development, they shared insights on how physician feedback, novel engineering architectures, and strategic IP development are shaping FastWave’s next-generation IVL platforms.

What distinguishes FastWave's IVL platform from other calcium modification technologies currently on the market, both in terms of mechanism and clinical benefit?

Tristan: FastWave's dual-platform approach to intravascular lithotripsy (IVL) represents a fundamental advancement in calcium modification technology, addressing limitations of first-generation IVL systems.

From a deliverability standpoint, we're solving for critical access challenges that limit treatment options. Sola™, our coronary laser IVL (L-IVL) system, eliminates the traditional tradeoff between balloon length and catheter size through the inclusion of our translating emitter design, which removes the need for multiple fixed emitters and enables an ultra-sleek profile. 

We've also reimagined workflow integration and system durability. Our platforms eliminate the reusable dongle used in legacy IVL systems and features a one-click, hands-free activation, reducing setup and turnover time. Because our systems are AC-powered, there's no generator charging downtime. Additionally, our dual-layer, rupture-resistant balloon design has demonstrated superior reliability — Artero™, our electric (E-IVL) platform for peripheral artery disease (PAD) showed a 0% rupture rate in our first-in-human study, for example.

Sukanya: From a technology perspective, we've fundamentally reimagined how sonic pressure waves are generated and delivered. Artero™ utilizes independently powered emitters that deliver uniform, circumferential sonic pressure, eliminating the uneven energy delivery and localized degradation issues that plague legacy IVL systems. Sola™ takes an entirely different approach with a single, translating laser emitter that delivers true 360° sonic pressure with every pulse, ensuring consistent and controlled energy delivery throughout the treatment zone.

The engineering behind our pulse delivery systems drives significant procedural efficiency gains. Artero™ operates at 4 Hz and Sola™ at 5 Hz — significantly faster than the 1-2 Hz delivery of other IVL platforms. This speed difference results in a meaningful clinical impact: Sola™ can treat a 24 mm lesion significantly faster than first-gen IVL devices. This dramatic reduction in treatment time is especially significant for reducing ischemic time in patients with compromised cardiac function.

These technical innovations translate into tangible clinical benefits: improved access to challenging anatomy, more predictable calcium modification, and reduced procedure times — ultimately enabling physicians to treat more patients more effectively.

Can you elaborate on the significance of the eighth U.S. patent and how it strengthens your IP position or supports future product iterations?

Tristan: When you consider that FastWave is only four years old, securing eight U.S. patents is really quite remarkable — it speaks to our team's innovative capabilities and how seriously we've approached building our intellectual property portfolio from day one.  This isn't just about collecting patents for the sake of it — we're strategically protecting the core technologies that differentiate our platforms.

This eighth patent specifically strengthens our position in the E-IVL domain, complementing our L-IVL innovations and reinforcing our dual-platform strategy. It demonstrates that FastWave isn't just developing one breakthrough technology — we're building a comprehensive IP foundation that supports multiple product iterations and market opportunities.

How has feedback from interventional cardiologists and vascular specialists shaped the development or refinement of your IVL system to date?

Tristan: Our entire development philosophy has been built around what we call "problem-first design" — we started by spending extensive time with interventional cardiologists,vascular surgeons, and interventional radiologists to understand their daily frustrations with existing IVL technology, then engineered backward from those pain points.

One of the clearest examples came from physician feedback about the workflow challenges with legacy systems. Doctors were consistently telling us about the hassle of dealing with reusable dongles and the time lost to generator charging. That direct input led us to make some compelling improvements to the user experience with our streamlined, plug-and-play, AC-powered unit with one-click therapy activation — no dongles, no downtime, no having to hold down a button to activate therapy. 

Sukanya: From an engineering standpoint, physician feedback has been absolutely critical in identifying the real-world performance gaps that spec sheets don't capture. We’ve spent considerable time listening to physicians describe moments when existing IVL technology simply didn’t meet their clinical needs.

What became clear was that legacy IVL systems had fundamental engineering limitations that were creating clinical constraints. Physicians were dealing with limited energy pulses and unpredictability when treating eccentric or nodular calcific lesions. The fixed emitter placement in traditional IVL devices leads to stiff balloons that struggle in challenging anatomy, while also producing sonic pressure that is surprisingly variable.

Those technical insights drove us to question the underlying physics of how sonic pressure waves should be generated and delivered. With Sola™, we moved to laser-based acoustic pressure wave generation with a translating optical emitter — a novel approach designed to address deliverability and crossability.

The feedback also revealed that physicians preferred real-time control over energy placement versus having to consistently reposition the balloon. That's what convinced us to pursue fundamentally different technical architectures rather than optimizing existing designs.

What are your near-term commercialization plans, including target markets or procedural indications, and how do you plan to scale adoption?

Tristan: With IVL, we're talking about a total addressable market exceeding $9 billion that is projected to grow by over 20% annually for the next 5+ years.

The adoption trajectory of the therapy has been remarkable. In just two years, IVL utilization in PCIs went from essentially zero to nearly 10%. Global coronary penetration is projected to nearly double to approximately 20% by 2027 — that's the kind of market momentum you want to ride.

In the near term, we're focused on building robust clinical evidence, progressing from our successful first-in-human studies toward larger pivotal trials that will support regulatory approvals. As we get closer to commercialization, we're betting that superior user experience will build physician loyalty through IVL devices that are simply faster, more deliverable, and more predictable than what's available today.

Sukanya: One of the more unique aspects of our dual-platform approach is that it recognizes office-based labs (OBLs) and ambulatory surgery centers (ASCs) often have fundamentally different needs than traditional hospital settings. Rather than forcing one technology to work across all care settings, we've engineered purpose-built solutions that can be optimized for specific environments. 

How does being named to the Fierce 15 list align with FastWave Medical's broader vision for leadership in cardiovascular innovation?

Tristan: The Fierce 15 recognition offers powerful external validation from a respected industry publication that we're truly one of the most promising and disruptive private medtech companies out there.

The timing is really noteworthy — it came right after our first-in-human cases with Sola™ and coincides with our eighth patent milestone. That's indicative of the momentum we're building as we continue growing the company and pursuing our next phase of development.

In a sense, the award is like a seal of approval, giving external credibility to our claims about developing truly disruptive technology. But beyond the immediate benefits, it signals something bigger: that the broader medtech industry recognizes we're building something that could give doctors a more precise tool for addressing calcific disease.