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Puzzle Medical Devices

Puzzle Medical Devices

Transcatheter Heart Pump

Andrew Kuzemczak
August 20, 2025

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TL;DR

Puzzle Medical Devices was founded to fill a critical gap in heart failure treatment with ModulHeart, a minimally invasive, modular heart pump for patients too high-risk for surgery but needing chronic support.
ModulHeart’s innovative design—assembled inside the patient via transcatheter delivery—improves cardiac output, kidney function, and quality of life, while avoiding the blood trauma and procedural risks of traditional pumps.
With heart failure affecting millions and costing hundreds of billions annually, ModulHeart targets a massive unmet market, offering patients better outcomes and the healthcare system potential cost savings.

Hi friend,

Welcome back to Future Human! Welp, it’s over. The final “real” summer vacation of my life is done. M1 summer is a rite of passage for any medical student, and I feel lucky mine exceeded every expectation. I’ve arrived at the neuro unit—suntanned, excited, and somehow still exhausted. That said, I am looking very forward to learning more, even if the heart remains superior to the brain in my…brain.

We’ve got eight weeks ahead in what we call Brain and Behavior, followed by stints in dermatology, infectious disease, and musculoskeletal, before rotations kick off. Fun fact: not only was this my final summer ever, it was also my last “first day of school” as I start my final semester of classes. Life is FLYING! Time to start choosing a cemetery plot, maybe grab a walker… just kidding, just kidding. Any advice on slowing life down would be greatly appreciated. Medical school has been incredible—but it sure isn’t making time any slower.

Even though we’re officially in the neuro unit, my allegiance remains firmly with cardiology. So this week, we’re taking a detour back to the heart. I’ve been following this Canadian medtech team for over a year, and I’m beyond excited to share their story with you.

So with that, let me ask you:

What if a tiny heart pump could keep your blood flowing strong without ever opening your chest—a glimpse into the world of minimally invasive procedures and the future of cardiac care?

The Story

Heart failure remains one of the most devastating conditions in modern medicine, affecting over 30 million people worldwide and driving enormous healthcare costs. For decades, device-based therapies have focused either on short-term support for acutely ill patients or on surgically implanted pumps for those eligible for advanced interventions. That left a wide swath of patients in the middle—too sick for drugs alone, but too high-risk for invasive surgery.¹^,²

Montreal-based Puzzle Medical Devices was born in 2018 to address exactly this gap. The founding team—François Trudeau (robotics engineering), Jade Doucet-Martineau (mechanical engineering), and Gabriel Georges (cardiac surgery)—set out to design a low-risk, minimally invasive heart pump that could provide chronic support without the complications that plague current options. Each founder took a complementary role: Trudeau leading product development, Doucet-Martineau guiding business and operations, and Georges overseeing clinical and regulatory strategy. Together, they envisioned a heart pump assembled inside the patient, piece by piece, via a proprietary transcatheter approach—minimally invasive for the win!¹

Early on, Puzzle attracted the attention of Front Row Ventures, Canada’s first student-run VC fund, which backed the company’s first preclinical studies in collaboration with McGill University. Momentum built quickly: by 2019, the team had secured the Pierre-Péladeau Grant, appointed interventional cardiologist Dr. Philippe Généreux as Chief Medical Officer, and launched studies validating their technology.

The company’s flagship product, ModulHeart, is designed to reduce cardiac afterload and improve kidney perfusion without the blood trauma caused by traditional high-speed pumps (more on that later). ModulHeart is intended for long-term use—bridging a massive treatment gap for patients who otherwise face progressive decline. That promise earned Puzzle FDA Breakthrough Device Designation in 2021, accelerating its regulatory pathway.

Funding followed clinical progress. A first-in-human study in 2022 demonstrated safety and performance, leading to a CAD $34 million Series A round in 2023 led by Cordis-X (backed by Ajax Health, KKR, and Hellman & Friedman). By 2025, Puzzle had secured another CAD $43 million from an investor syndicate including KF Matheson, Desjardins Capital, Lumira Ventures, and BDC Capital’s Thrive Fund.¹

An interesting case study for the future business operators among us, Puzzle has championed a strategy leaning on a global network of partners. From Sterling Medical Devices for controller development to MMC Medical International Services for clinical trial support—they ensure their technology is built to scale.

The vision is clear: to deliver a durable, minimally invasive mechanical circulatory support (MCS) system for patients underserved by today’s therapies.

The Tech

At the core of Puzzle Medical Devices’ vision is ModulHeart, a minimally invasive, long-term hemodynamic transcatheter pump. Unlike current devices that require open-heart surgery, ModulHeart is designed around a modular approach: the system is assembled inside the patient using proprietary transcatheter technology. This design offers a safer alternative to traditional surgical pumps, with the goal of extending chronic circulatory support to patients who have historically been left without viable options.²

The device provides hemodynamic support through three endovascular pumps that are inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta. This unique configuration helps reduce stress on blood elements compared to traditional small pumps that operate at extremely high speeds, which often cause significant hemolysis and limit their use to short-term applications. By offering a modular structure with lower shear stress (a force acting parallel to a surface, causing the material to deform or slide past itself), ModulHeart is built for long-term support where other minimally invasive devices have failed.

To support real-world use, Puzzle has developed a portable controller that is small, lightweight, and powered by a long-life battery to maximize patient mobility. The controller is paired with a bedside monitoring station that provides physicians with a comprehensive interface for programming and monitoring pump function during procedures. ModulHeart is truly a system designed around both patient independence and clinician oversight.

The promise of this design was validated in Puzzle’s first-in-human study, published in September 2022. Four patients underwent high-risk PCI with ModulHeart implanted via transfemoral access. The procedure achieved 100% procedural success with an average delivery time of eight minutes and pump removal in seven minutes. The results were striking: cardiac output increased by 25%, urine output rose nine-fold within 15 minutes, and left ventricular end-diastolic pressure dropped by 78%. Importantly, no device malfunctions, thrombosis, or procedural complications were observed, and all patients were alive at 30 days.

Patients with end-stage heart failure who fail medical therapy currently face extremely limited options. Existing mechanical circulatory support devices are expensive, surgically implanted, and largely reserved for only the sickest patients. There is thus a tremendous unmet need for a minimally invasive, chronic support system like ModulHeart—one that could reduce global heart failure burden while extending both survival and quality of life for patients.²^,³

In context, ModulHeart sits within a larger landscape of FDA-approved and investigational pumps for hemodynamic support. Most existing devices were designed for left ventricular assistance and fall into short-term (temporary) or long-term (durable) categories, using volume displacement, centrifugal, or axial flow mechanisms. But durable right ventricular support options remain largely unavailable. Puzzle’s technology, with its modular and minimally invasive design, is positioned to expand the frontier of mechanical circulatory support where other devices have yet to reach.⁵

The Market

The market for cardiovascular devices and procedures is vast and expanding rapidly. In the United States alone, cardiology procedures generated an estimated $55 billion in 2023, with expectations to grow at a compound annual growth rate (CAGR) of 7.7% through 2030. Growth is being fueled by multiple forces which we have mentioned before: an aging population, rising rates of cardiovascular disease, and continued advances in device technology. By 2030, nearly 82 million Americans will be over the age of 65, further straining healthcare systems with the burden of heart disease and driving demand for innovative interventions.⁶

Globally, the cardiovascular devices market was valued at $53.7 billion in 2024 and is projected to reach $86.4 billion by 2030, expanding at a CAGR of 8.4%. This growth reflects not only the rising prevalence of cardiovascular disease worldwide but also the accelerating adoption of minimally invasive surgeries and device-based solutions. Major players in this space include Abbott, Edwards Lifesciences, Medtronic, Boston Scientific, GE HealthCare, Siemens, and BIOTRONIK—companies with decades of experience and distribution networks spanning the globe.⁷

Despite the dominance of large manufacturers, the rapid pace of innovation has created openings for specialized startups. For example, Medtronic’s launch of its Avalus Ultra surgical aortic tissue valve in 2024 highlights how even the biggest incumbents must continuously update portfolios to remain competitive. Against this backdrop, nimble companies with differentiated approaches can carve out space—particularly in underserved segments.

Puzzle Medical Devices is positioned precisely in one of those underserved niches. Current device-based therapies for heart failure fall into two categories: surgically implanted durable pumps designed for the sickest patients, or minimally invasive pumps intended only for short-term support. Patients who are too high-risk for surgery but require chronic circulatory assistance are largely left without options. ModulHeart, with its minimally invasive, modular design for long-term support, targets this unmet need directly. By offering a therapy that bridges the gap between drugs and surgery, Puzzle sets itself apart in a market where most solutions are either too invasive or too temporary.²^,⁶

The interventional cardiology segment, which accounted for more than 53% of the $55 billion U.S. cardiology procedures market in 2023, is projected to grow at the fastest rate among categories—8.1% annually—over the coming years. With its transcatheter platform and compatibility with existing interventional workflows, ModulHeart is naturally aligned with this trajectory. Once they are more established, partnerships with leading hospitals such as Cleveland Clinic, Mayo Clinic, and NY Presbyterian (!!!)—institutions at the forefront of interventional cardiology—will be critical for future adoption and scaling.⁶

In an environment dominated by global giants, Puzzle Medical’s differentiation lies not in competing head-to-head across all device categories, but in pioneering a new class of long-term, minimally invasive heart pumps. If successful, it could establish itself as the company that finally fills one of the largest gaps in cardiovascular medicine.

The Sick

Heart failure, or congestive heart failure, is one of the most serious and widespread conditions in modern medicine. It develops when the heart can no longer pump enough blood to meet the body’s needs, either because it cannot fill adequately or because it is too weak to contract properly. The name is misleading to be frank—heart failure does not mean the heart has stopped, but it is a progressive and often debilitating disease requiring lifelong medical care.⁸

The burden is immense. More than six million adults in the United States live with heart failure, and the number is expected to rise as the population ages. Symptoms vary depending on whether the left or right side of the heart is affected. Patients may struggle to breathe, experience severe fatigue, or notice swelling in the legs, abdomen, and veins of the neck. Over time, heart failure robs patients of independence and drastically diminishes quality of life.⁶

The risks are compounded by genetics, lifestyle, and other health conditions. High blood pressure, coronary artery disease, diabetes, chronic kidney disease, sleep apnea, and obesity all increase the likelihood of developing heart failure. Despite modern medical advances, there is no cure, and the condition remains one of the leading causes of death worldwide. In the U.S. alone, one person dies from cardiovascular disease every 34 seconds, and in 2023 more than 919,000 Americans lost their lives to heart-related illnesses.⁸^,⁹

Treatment today is limited. Drug therapy can slow progression but often fails in advanced stages. Devices like biventricular pacemakers and implantable defibrillators offer symptom relief but do not address declining cardiac function. Mechanical circulatory support systems, such as ventricular assist devices or total artificial hearts, can provide life-saving help, yet these are typically reserved for the sickest patients due to the need for open-heart surgery, high costs, and risks of complications.

This is where Puzzle Medical’s ModulHeart is poised to make a difference. By offering long-term hemodynamic support through a minimally invasive, modular system, ModulHeart could extend device-based therapy to a population of patients who are currently underserved—those too high-risk for open-heart surgery but too sick to rely on medication alone. The device’s design emphasizes patient mobility and quality of life: a portable controller, bedside monitoring, and transfemoral delivery mean patients can receive powerful cardiac support without sacrificing independence. For many, this could mean less fatigue, more energy, improved kidney function, and the chance to live not just longer, but better (healthspan vs. lifespan).

In a disease that robs patients of dignity, independence, and time, technologies like ModulHeart represent more than engineering—they represent hope.

The Economy

In the United States, roughly 1,000,000 new patients are diagnosed with heart failure each year, and by 2030 more than eight million Americans—about one in every 33—are expected to be living with the condition. Annual costs of care are substantial, averaging near $30,000 per patient, with the majority of expenses coming from inpatient care. Nationwide, total costs of heart failure are projected to reach $160 billion per year by 2030, including both direct care and indirect costs such as lost productivity, representing $244 per U.S. adult annually.¹⁰

Racial disparities further compound this economic burden. Data from the ARIC study (2005–2014) show significantly higher age-adjusted heart failure hospitalization rates among Black patients compared to White patients, with rates increasing faster over time. For example, Black men experienced a +3.7% annual increase versus +2.6% for White men, while Black women saw a +4.3% increase compared to +1.9% for White women.

Mechanical circulatory support (MCS) devices, such as ventricular assist devices or total artificial hearts, can extend life expectancy and improve quality of life for patients with advanced heart failure. However, they are associated with ongoing outpatient care and frequent readmissions. Cost-effectiveness analyses show that MCS as a bridge to transplant ranges from approximately $80,000 to over $200,000 per quality-adjusted life-year (QALY), while long-term destination therapy can approach $200,000/QALY.

Globally, heart failure affects an estimated 26 million patients, resulting in annual spending of $108 billion. Hospitalization and readmission remain the largest drivers of cost, and progress in post-discharge mortality and readmission rates has been limited despite improvements in therapy.¹⁰

Puzzle Medical Devices’ ModulHeart has the potential to shift this landscape. By offering long-term, minimally invasive hemodynamic support, the device could reduce hospitalization and readmission rates while improving patient outcomes. A safer, more effective cardiac pump could lower lifetime treatment costs, enhance quality-adjusted life years, and relieve a portion of the staggering economic burden imposed by heart failure. In both the United States and globally, such a technology promises not only better patient lives but also meaningful cost savings across healthcare systems.

My Thoughts

One of the most inspiring things about Puzzle Medical Devices is the trio of founders—François Trudeau, Jade Doucet-Martineau, and Gabriel Georges—who brought together complementary skills in robotics, mechanical engineering, and cardiac surgery to tackle a problem that none of them could solve alone. Their approach embodies a mindset I try to adopt in my own work: find a few people whose strengths fill the gaps in your own, then focus relentlessly on the shared vision. There’s a particular beauty in how they’ve combined their expertise to create ModulHeart. Beyond the engineering, the significance is profound: they are giving hope and independence to patients previously left without options. For me, Puzzle Medical Devices proves that with the right team, a few smart people can change the game—and maybe even save a few hearts along the way.

To more lives saved,

Andrew

I always appreciate feedback, questions, and conversation. Feel free to reach out on LinkedIn @andrewkuzemczak.