A Tale Of Two Sites: How FastWave Ran Trials In Distinct Locales

A conversation with Trent Mengel, head of clinical, FastWave Medical

You might think that running clinical trials in Mexico and Uzbekistan would be very different experiences. And, for the most part, you’d be right.

Reflecting on clinical trials for both the Sola™ laser intravascular lithotripsy (L-IVL) system and the Artero™ electric IVL (E-IVL) system, FastWave Medical Head of Clinical Trent Mengel sees a lot of distinctions. One country is better attuned to FDA requirements, and the other has a more eager patient population. One has KOLs close at hand, and the other embraces legacy procedural techniques.

In this Q&A, Mengel recounts the differences his company encountered during site feasibility and shares how they addressed and accommodated them, while still ensuring viable data collection and patient safety. Additionally, he shares the mindset it takes to find success across the globe, including who to partner with and how.   

Clinical Leader: Mexico and Uzbekistan appear to be distinct locations. What are the benefits of running trials in each of these countries? How do the two countries combine to provide a holistic research picture?

Trent Mengel: Running early-phase medical device clinical trials in Mexico and Uzbekistan isn’t just about geographical diversity — these countries offer complementary advantages that help us in the pursuit of regulatory approval and global market access.

Mexico brings us closer to the U.S. regulatory pathway. We benefit from experienced investigators, regulatory frameworks that align well with FDA requirements, and diverse patient populations that reflect the demographics we’ll ultimately see in North American markets. The prevalence of peripheral artery disease (PAD) risk factors in Mexico is exceptionally high, driven by diabetes burden, limited access to preventive care, and socioeconomic factors that mirror underserved populations in the U.S. These are some of the reasons we selected San Lucas Hospital in Tuxtla Gutiérrez for our prospective single-arm FIH study to assess FastWave’s electric intravascular lithotripsy (E-IVL) system in patients with PAD.

Uzbekistan offers something quite different. The country consistently ranks in the top 20% globally for cardiovascular mortality — we’re talking nearly 100,000 deaths annually from heart and vascular diseases. The confluence of risk factors for calcific artery disease (CAD) is extraordinary: high rates of hypertension, diabetes, dyslipidemia, obesity, and genetic predisposition are common in Central Asian populations. From a practical standpoint, their centralized health system enables rapid enrollment, and recent regulatory reforms have focused on harmonizing with global standards, which improves regulatory predictability for startup device companies like FastWave.

What aspects of feasibility could easily be applied to both countries, and which had to be adapted? Why?

Despite their different geographies, our basic operational approach was consistent — site evaluation, protocol standardization, investigator training, and patient recruitment. Of course, you translate everything and find partners who can communicate in English, but those are table stakes. The real adaptations happen in execution.

Regulatory pathways are completely different animals. Mexico can leverage foreign approvals to accelerate timelines. Uzbekistan requires classification reviews on their own schedule. You can't copy-paste your strategy — you need to map how each study feeds into your broader approval pathway.

Infrastructure and site capabilities required the most careful navigation. You have to know exactly what your study needs and verify the sites can deliver it. We learned this in Uzbekistan when we'd nearly completed site selection and discovered that a few sites didn't have access to intravascular ultrasound (IVUS) equipment, which our coronary study required. That experience taught us to be extremely specific up front about equipment requirements and operator experience.

Procedural variations required nuanced judgment calls. In the U.S., interventional cardiologists routinely use guide extension catheters. In Uzbekistan, it's a last resort. I didn't want to force them to change their standard practice and introduce variables we couldn't control.

Bifurcation stenting is another example. The Uzbekistan team often uses a double-wire technique — sending guidewires down both the left circumflex (LCx) and left anterior descending artery (LAD), then working on each vessel before placing stents back into the left main from both branches. This is known as the culotte technique. The main disadvantage of this technique is that rewiring of both branches through the stent struts is required, which can be difficult, technically demanding, and time-consuming. That's not typical U.S. practice, where crush/DK crush techniques are more common, but the Uzbekistan team executed it well and got good results. Why introduce risk by making them do something unfamiliar? You have to weigh whether forcing physicians away from their proven standard of care creates more risk than benefit.

Mexico needed different support — bringing in U.S. KOLs to work alongside local physicians in regions with high unmet needs but variable research infrastructure.

What partners did you select to help you navigate the process in each location? And what expertise did they provide?

We've built an extensive network of physician collaborators over the years, but for these studies, we needed partners with very specific expertise and deep local knowledge.

In Mexico, we worked with Hendosyn Clinical Research, led by Dr. Miguel Montero-Baker. They brought clinical expertise in vascular disease trials and established relationships with sites that had the patient volumes we needed for PAD studies, and they handled regulatory navigation — understanding how to leverage existing foreign approvals and manage local ethics committee processes. Miguel is an exceptional physician partner, and in addition to his support, we also worked alongside Drs. Jose Antonio Munoa Prado and Venkatesh Ramaiah. Collaborating with physicians experienced in early-stage feasibility studies is crucial.

In Uzbekistan, we partnered with Clinical Accelerator, a full-service CRO with deep roots in the region. Their CEO, Dr. Nikolai Nikitin, is actually from Uzbekistan, which proved invaluable. They handled everything from regulatory submission to site qualification, investigator training on GCP compliance, and managing device import and insurance requirements. Given Uzbekistan's evolving regulatory landscape, having partners who understand both the current system and where it's heading was critical.

What both partnerships delivered was more than logistics: it was genuine clinical engagement and commitment to data quality. Both  teams in Mexico and Uzbekistan were completely aligned on making the studies succeed. They routinely asked, "What do we need to do to make this really, really good?" And they delivered. The sites screened thoroughly, provided comprehensive patient data, and maintained strong patient retention throughout the studies.

To what extent do you need to understand and accommodate the culture of these two places? How much do you rely on local partners in this regard?

In my experience, cultural understanding isn’t optional: it fundamentally shapes whether your study succeeds or fails. You can have a perfectly designed protocol, but if you don't understand how people in these communities think about healthcare, research participation, and their own bodies, you won't enroll patients, and you won't retain them.

In Mexico, we had to navigate some real skepticism of clinical research. There's historical mistrust, concerns about being experimented on, and questions about whether the broader community will benefit from the research or if it's just extracting data to benefit wealthier countries. Language is obviously important — everything patient-facing must be in Spanish — but it goes deeper than translation.

Uzbekistan operates under a completely different healthcare model — it's socialized medicine. The country has even started its own manufacturing line for balloons, stents, and wires that are used in state hospitals. Patients aren't necessarily getting access to the latest technology available in the U.S. When you can convey to patients that participating in the study means they'll receive the best treatment and the best care — technology they wouldn't otherwise have access to — that's a powerful motivator. In a socialized system, patients are generally going to follow what they're told to do, but knowing they're getting superior care breaks down barriers and creates genuine engagement.

We relied heavily on our local partners for these insights. They're not just executing our protocols — they're actively shaping recruitment messaging, consent processes, and patient engagement strategies to align with local values. Their guidance is what makes the difference between a study that struggles to enroll and one where patients feel genuinely engaged and valued.

How are trials in these countries, regarding both site operations and regulatory requirements, positioned to provide trial data that could support FDA approval?

The short answer is that Mexico is much closer to FDA-ready, while Uzbekistan requires more work to get there, but both can generate approvable data if you design the studies properly from the start.

The key is building FDA compliance into every aspect from day one. We created our own case report forms (CRFs) and electronic data capture systems. We established safety plans and built in all the regulatory checkboxes FDA will look for. Then we verified sites are meeting those requirements — that's why we monitor 100% of cases. We want to confirm that what we documented is exactly what happened.

We record every procedure, download all images to our core lab, and ensure everything is properly anonymized — all the things you might take for granted in the U.S. but have to explicitly build into international operations. We make sites audit-ready from the beginning, knowing FDA can always choose to inspect.

In reality, this applies everywhere. There are U.S. sites that just aren't as good as others. Some are really strong clinical research sites and some just aren't. The location matters less than the operational rigor and oversight you put in place.

Our approach is straightforward: make the process easy, train everyone to it, document everything, and make sure it gets done. We have weekly calls with sites, but our director of clinical operations — Jerome Tonog, a New York-based doctor — is checking data as it comes in, sometimes two or three times a day. I'm reviewing it weekly myself. It's constant communication and oversight.

At the end of the day, you can run a study anywhere as long as you have good oversight. The outcomes are going to be what they are, but at least you'll have the records and data to support FDA submission — which is the key. We're not running "international standards" versus "FDA standards." We're running FDA-level standards everywhere, period.

Did you have any hesitations or unknowns heading into these trial locations, and how were they addressed?

Honestly, my biggest concern was patient recruitment and making sure we could execute efficiently when we're in a different country. You can't just call another hospital in town if you need a replacement device or if a patient screens out at the last minute.

Our solution was implementing a rigorous prescreening process. Sites uploaded comprehensive information about each potential patient — complete medical history, all imaging, everything. In Uzbekistan, for example, one site screened 27 patients for our 30-patient study, and the level of detail they provided was remarkable. This wasn't just checking inclusion/exclusion criteria; we could look at the whole patient and develop a complete treatment strategy before anyone got on a plane.

This approach de-risked the entire operation. We could identify screen failures up front, plan the clinical approach for each case, and determine exactly which devices we'd need. We ended up shipping about 39 devices and had only two left over, which is the kind of precision you need when you're operating internationally. There's no room for "we'll figure it out when we get there."

Beyond clinical planning, we addressed logistical and safety concerns through meticulous coordination. We addressed safety through security vetting of our team and travel regions, and had our distributor handle all ground transportation — airport pickups, hotel to hospital, etc. We traveled together, maintained extensive checklists, and left nothing to chance.

The key to managing unknowns is communication. We had weekly calls with sites, but I was also on the phone two to three times a week with PIs just talking through patient details. We used the Telegram app because that's what they preferred. Being available and fostering open communication addressed most concerns before they became problems. Some of it's good planning, some of it's luck, but you maximize your odds by staying engaged and organized.

What advice would you give to sponsors embarking on global trials in these regions? What must they do or understand before moving into these countries?

The most important lesson: Know what your study actually needs to accomplish, then verify sites can deliver it before you're too far down the path. Build your site criteria around capabilities, not just patient volumes.

Second, be strategic about where regulatory speed matters. We worked in Chiapas, Mexico, where we could start in about six weeks. Costa Rica has better insurance and more established infrastructure but takes six to nine months to get started and has more regulatory requirements. Patients there also aren't as dire, so enrollment is slower. Understand those trade-offs based on your timeline and patient population needs.

Third — and this is critical — know when NOT to enforce U.S. standards. As I mentioned earlier, in Uzbekistan, physicians handle bifurcation stenting differently than we do in the U.S. Their approach works well for them. If I'd forced them to use unfamiliar techniques, I'd be introducing variables and risk complications they're not experienced managing. You have to weigh whether deviating from their standard of care creates more problems than it solves.

Fourth, treat early cases as learning opportunities. We screened out certain anatomies based on what we learned from initial procedures. We refined how we used our own device — treating what we were seeing rather than following rigid steps. Those learnings informed better patient selection going forward.

Finally, to be honest, it's a combination of planning and luck. We did 21 cases in six days, which is hard to pull off anywhere. You maximize your odds through detailed preparation, but stay humble about what you can control.

About The Expert:

A U.S. Army veteran and licensed surgical first assistant, Trent Mengel, now head of clinical at FastWave Medical, brings more than 30 years of experience in global clinical research and trial management. He has led clinical programs for both emerging startups and established medtech companies, including Xeltis, Boomerang Medical, Reflow Medical, Endologix, LimFlow, Intact Vascular, and Edwards Lifesciences.

Trent began his career as a combat medic in the U.S. Army Reserves and later worked as a certified surgical assistant before transitioning into clinical leadership. He holds a Master of Science in Instructional Design & Development and a Bachelor’s degree in Management from Bellevue University.