The Thomas J. Fogarty Innovation Prize and the FARAPULSE Team: Transformative Innovation Brought to Life

The inaugural Thomas J. Fogarty Innovation Prize celebrates the boldness, perseverance, and human impact that define the very best of medtech innovation. At its first annual gala, the award was presented to former CEO and Co-Founder Allan Zingeler and CTO Raju Viswanathan, PhD, both of FARAPULSE, and Michael Mahoney on behalf of Boston Scientific for FARAPULSE, pioneers of a breakthrough therapy that is transforming the treatment of atrial fibrillation (AFib). This spotlight explores the vision behind the Prize, the legacy of Dr. Fogarty, and the extraordinary journey of the FARAPULSE team that embodies the award’s purpose.

Celebrating a New Standard for Transformational Innovation

When more than 300 members of the medtech community gathered in San Francisco for the inaugural Thomas J. Fogarty Innovation Prize Gala, the night carried both gravitas and celebration. In his opening remarks, Fogarty Innovation CEO Andrew Cleeland captured the significance of the occasion. “Tonight marks the inaugural Thomas J. Fogarty Innovation Prize Gala and what we hope will be the first of many such evenings for decades to come,” he said. “It really is something to see this extraordinary community gathered together in one place, all united by a shared purpose.”

The inaugural winners were Allan Zingeler, Raju Viswanathan, PhD, and Michael Mahoney for their work on the FARAPULSE PFA Platform. Their achievement is not simply a commercial or clinical milestone; it represents a fundamental shift in how AFib can be treated safely, effectively, and at scale. As Cleeland noted, “The Prize exists to honor trailblazers whose innovations have created profound clinical impact, not just bold ideas but bold ideas successfully translated into meaningful patient benefit.”

The excitement that filled the room was rooted in both the transformational impact of FARAPULSE and the meaning behind the Prize itself.

A Prize Built on a Legacy of Vision, Mentorship, and Courage

The Prize was inspired by a longstanding relationship between Dr. Tom Fogarty and Mike Mussallem, former Chair and CEO of Edwards Lifesciences. As Cleeland explained, “Mike wanted to create a lasting tribute to Tom’s impact, and through the Linda and Mike Mussallem Foundation, he generously endowed the Prize.”

Cleeland, who has known Dr. Fogarty for nearly three decades, describes Dr. Fogarty’s impact on medtech innovation as unparalleled. “From an early age, he had a rare ability to see things not as they were, but as they could be,” he said.

Dr. Fogarty’s inventions and philosophies shaped entire categories of medical devices and established new pathways for minimally invasive treatment. “While still in medical school, he invented the balloon embolectomy catheter, which transformed vascular surgery by enabling safe, minimally invasive clot removal. That breakthrough was only the beginning; his contributions span surgical clamps, aortic stent grafts, tissue valves, and scores of foundational ideas that have enabled hundreds, if not thousands, of companies across all of healthcare,” Cleeland emphasized.

But in Cleeland’s eyes, his most enduring contributions extend beyond technology. “While he attributes his career to mentors in his life, it is his mentorship that I believe has had the most profound impact on medtech innovation,” he said. “His pragmatic approach to innovation, that good ideas were meaningless until they were accepted by others and used to help patients, forms the foundation of effective innovation.”

These values are deliberately woven into the Prize criteria. Cleeland emphasized that the selection process was rigorous, rooted in independent committee review. “The committee considered novelty, clinical impact, commercial adoption, resilience, leadership, and alignment with Tom’s own legacy,” he said. After extensive deliberation, the FARAPULSE team stood out.

Inside the FARAPULSE Vision

FARAPULSE originated from a simple but radical belief: that AFib could be treated without the thermal risks inherent to radiofrequency (RF) or cryoablation. As Co-Founder and CEO of FARAPULSE Allan Zingeler recalled, “The first aspect of pulsed-field ablation (PFA) that was impressive to me was the concept of tissue selectivity, which heralds unequaled safety. Practically, this means that you can tune your device to ablate the tissues you want to and not to ablate tissues/structures you want to preserve. What a bold proposition!”

He continued, "All ablation modalities up to that point were thermal. With PFA, there is no thermal-driven zone of injury. Instead, there is a temporary electric field with a waveform finely tuned to ablate the target tissue without harming the surrounding sensitive structures at all.”

Zingeler saw early on how transformative this would be for both operators and patients. “Because of this safety net, the operator can ablate more confidently and actually neutralize all of the target tissue, increasing the long-term efficacy of the procedure,” he said. “PFA eliminates many of the most feared complications of traditional ablation.”

Engineering a Breakthrough

The promise of PFA was clear, but safely delivering on it required years of scientific persistence. Zingeler described the early technological limitations bluntly. “Back in 2013, most of the applications were in industrial food use, and early pre-clinical and clinical work with PFA was done with crude devices with overly aggressive energy deliveries.” At that time, all PFA devices were monopolar and monophasic and demonstrated unacceptable side effects in pre-clinical work. “It took us years to figure out how to dramatically lessen those side effects,” he said.

FARAPULSE made several pivotal advances, including transitioning to bipolar and biphasic solutions and designing a flexible catheter electrode geometry that maximized the desired ablation effect while dramatically minimizing the thermal effects. 

One of the most challenging clinical problems was the variability of human pulmonary veins. “They are various sizes and shapes and numbers,” he said. The team solved this with its flower/basket catheter design, capable of adapting to a wide range of anatomies. They also refined a consistent dosing strategy. “We ended up with a formula of eight ablations per vein in two configurations. It goes quite rapidly, and most importantly, it works time after time in physicians’ hands.”

A Breakthrough Fueled by Evidence and Enthusiasm

From the beginning, FARAPULSE prioritized science. “At the time of initial European launch, we had dozens of compelling pre-clinical papers and about ten clinical papers, all in respected journals,” Zingeler said. “By the time of initial U.S. launch, we had almost 100 scientific publications and over 40,000 cases completed in Europe, along with a 17,000-patient registry.”

This depth of evidence created powerful momentum. “After those first few cases, there was a universal appreciation for FARAPULSE,” he said. Once introduced in the U.S., adoption soared. Today, FARAPULSE is recognized as one of the fastest-adopted technologies in medical device history.

GPs and cardiologists noticed almost immediately. As Zingeler shared, “Once we achieved the outstanding safety profile of FARAPULSE, the referring network was eager to get their patients off antiarrhythmic drugs that often don't work for patients and onto a safer, more effective treatment.” He recalled going to an annual checkup less than a year after the U.S. launch. “My GP started talking up how incredible FARAPULSE was and how it was changing practice. Wow.”

A Collaboration Years in the Making

Boston Scientific was an early investor and essential partner. “Boston Scientific was an early and unwavering investor in FARAPULSE,” Zingeler said. “They provided useful in-kind support and active dialogue.” When integration came, the relationship enabled a smooth transition. “Once acquired, the Boston Scientific team hit the ground with a running start.”

In a video about FARAPULSE screened during the ceremony, Mike Mahoney, Chairman and CEO of Boston Scientific, commented that in more than thirty years in medtech, he had never seen a product transform safety, efficacy, and productivity with such clarity. 

Why the FARAPULSE Team Stood Out

Cleeland described the selection process as extensive and deeply considered. “The committee individually reviewed each nomination before convening for a full panel discussion,” he said. “After thorough deliberation, the committee concluded that the FARAPULSE team most fully met the selection criteria.”

When Zingeler learned FARAPULSE had been chosen, he felt both surprise and deep humility. “To have FARAPULSE selected as the inaugural winner of the Thomas J. Fogarty Prize is the pinnacle of my long medical device career,” he said. “The award means much more than accolades; it is from our peers, and as such, from people who know all the ups and downs and the exhilaration when it all works.”

Looking Forward: A Legacy That Will Shape the Future

As the Prize moves into its next years, Cleeland hopes it will strengthen the medtech ecosystem as a whole. “I hope that the Prize elevates awareness of our innovation community, celebrates our relentless focus on improving patient care, and reminds us that the hard days (and there are many hard days in medtech innovation) are worth it,” he said. “I hope it reminds future innovators of Tom’s core belief: there is always a better way, and we each have a responsibility to find it.”

Zingeler hopes future innovators draw a clear lesson from the FARAPULSE story. “It can be done,” he said. “Have a thorough look at the unmet need you want to solve, gather the best people around you, partner with funders who believe in your vision and your team, and work relentlessly to overcome the hurdles and achieve success. The best outcomes are when the doctor and the patient are smiling; that’s when you know you nailed it.”

The inaugural Fogarty Prize does more than honor a breakthrough. It marks the beginning of a tradition dedicated to celebrating the courage, discipline, and human impact that define the best of medtech. FARAPULSE exemplifies this spirit. And with the Fogarty Prize now established, future innovators will have both a beacon and a challenge: to imagine boldly, execute rigorously, and always keep the patient at the center of the work.