Dr. Kurt Dasse’s journey into the medical field took an unorthodox path. Dr. Dasse served in the United States Navy, where he was a hospital corpsman, a medic, in Vietnam. His experiences during his service led him to desire to pursue a career in medicine or medical research. He attended the University of Massachusetts, earning an undergraduate degree, and later attended Boston University at the School of Medicine. Dr. Dasse doesn’t consider himself an inventor, but someone who can bring together teams to revolutionize and commercialize ideas by harnessing and synthesizing what is known.
Dr. Dasse co-founded Thermo Cardiosystems with Victor Poirier, where his leadership skills helped pioneer the development of the HeartMate LVAD series. He later joined Thermo Electron Corporation (currently Thermo Fisher Scientific) as the Chief Science Officer for the biomedical group of companies. The original HeartMate IP and HeartMate XVE LVADS would not have been possible without his determination in overseeing the clinical testing. He continued to play a role along with a great team of engineers in the development of HeartMate II. Later while heading up Levitronix as the CEO, he worked with a team in Switzerland that developed the MagLev system for HeartMate3. Levitronix also developed the CentriMag and PediMag devices. His work has helped bring advanced circulatory support devices to market, benefiting hundreds of thousands of patients.
A Conversation with Dr. Dasse
Henry: What was the clinical perception of VADs 40 years ago, and how did that influence your development priorities?
Dr. Dasse: VADs were in their infancy. They were a mock loop fantasy at the time. I remember being at an NIH contractor meeting when the first Jarvik total artificial heart was implanted in Barney Clark in 1982. We sat in awe, wondering how they dared to attempt it. It made us realize how far VADs still had to go through preclinical testing and later be introduced to the clinical setting. Our early devices would initially fail in the early clinical testing, but a few remarkable clinicians took an adaptive approach, asking, “Can we refine this? Can we collaborate?” Over time, skepticism gave way to adoption.
Henry: Was there a turning point where that skepticism started to fade?
Dr. Dasse: Early on, there was strong interest from the top transplant centers in the concept of VADs, but they maintained a healthy skepticism. The real turning point came with completion of the landmark REMATCH trial, which showed significant improvement in outcomes for LVAS candidates compared to the existing optimal medical therapy. While early, the results sparked clinician interest. The main challenge has been getting cardiologists to refer patients, but that’s improving.
Henry: What were the biggest engineering hurdles you faced when developing circulatory assist devices?
Dr. Dasse: Every device we worked on faced issues in the early clinical stage, despite extensive and thorough testing. Early failures, including patient deaths, occurred and were heartbreaking. HeartMate XVE had valve issues. HeartMate II had initial bearing issues. CentriMag faced electrical interference problems from other devices that ended up with a Class III recall. Device launches eventually became smoother after 15 years of lessons. I learned to stay calm in the face of setbacks. While I was not the inventor, I learned how to bring a device to market and deal with each crisis along the way.
Henry: Were there any differences dealing with the pediatric side compared to adult patients when you were crafting these devices
Dr. Dasse: Yes. What I learned is that pediatric device testing faces a much higher bar compared to adult devices, and obtaining FDA approval is harder – for good reason. Pediatric centers are highly risk-averse, so it was essential to communicate well and work closely with them. It was necessary to share the extensive testing and results with them. While devices intended for larger pediatric patients might get approved in a relatively short time, devices intended to obtain approvals for smaller pediatric patients takes much longer.
Henry: Do you see any current limitations or necessary breakthroughs regarding circulatory technology?
Dr. Dasse: I believe the limitations of the MCS technologies are well understood and mainly focus on continuously striving to reduce adverse events. A renewed interest in treating adult HfpEF patients with diastolic dysfunction promises to offer a breakthrough for adult patients with an unmet need. There remain challenges related to completing implantable pediatric device development. I have worked, for example, with the Jarvik Heart J2015 implantable pediatric LVAD. The feasibility study has been completed, and the FDA approved starting the pivotal trial. Launching the pivotal clinical trial has been slow mainly due to limited funding, leading to repeated starts and stops. A challenge with trying to develop pediatric devices is the small market size. And consequently, there is the challenge of keeping the clinical sites interested and confident that such a clinical trial can be completed in a reasonable period to time given the financial challenges.
The major barrier to completing development of pediatric devices in general is the lack of funding. I support more reliable, bearing-free systems such as the Maglev approach and am excited to see new technologies finally gaining traction after years of stagnation.
Henry: Can you walk us through the process of getting a device to market and point out some of the challenges that come along the way?
Dr. Dasse: Bringing a medical device like an LVAD to market takes a long time, about 10 years, from refining a prototype to completing preclinical testing, getting it through FDA reviews, and a clinical trial. Pediatric trials are particularly tough due to so many factors including obtaining clinical site buy-in, informed consent, and family challenges. Afterward, scaling up manufacturing and managing investor pressures require strong business, technical, regulatory, and operational skills.
Henry: What advice would you give to someone who is looking to start a medical device company or take on a similar role that you did?
Dr. Dasse: Bringing a device to market requires strong business, technical, and clinical expertise as well as strong intellectual property and engaged investors. The device must be thoroughly tested to meet ISO/FDA standards and may require up to 100 million dollars to get the device to market. Smaller, agile companies tend to outperform larger ones if adequately funded to accelerate a product to market, and stock options help keep the team motivated as the device reaches patients.
Henry: Was there a moment in your career that stands out to you or is there one that you would consider your favorite?
Dr. Dasse: Yes. Getting FDA approval for the first implantable LVAD. I recall presenting our implantable HeartMate IP LVAS to the FDA panel. This was the same day when the FDA panel rejected the first coronary stent. I was the lead presenter and provided an extensive statistical overview of the clinical results. The panel initially debated whether to recommend PMA approval. Given the gravity of the situation, the panel took a break. During the break, because Thermo CardioSystems was a public company, trading of the stock on Wall Street was halted. The company was also under consideration for a $30 million investment if it received PMA approval. Fortunately, we received unanimous PMA panel approval. Celebrating with the team that night was unforgettable. Obtaining the first FDA approval recommendation for the device was a huge milestone.
Henry: Was there ever a favorite moment or feedback from it in your clinical settings with the patient that stuck with you the most? How has your work touched others in a way that you remember?
Dr. Dasse: One pediatric story stands out. Dr. Peter Weardon at the University of Pittsburgh successfully used our PediMag device in a young boy on Valentine’s Day. The great outcome and the excitement of both Dr. Weardon and the family was very heartwarming.
Henry: What advice would you give to future doctors and inventors?
Dr. Dasse: Pediatric surgeons and cardiologists are deeply committed to their patients, sometimes facing heartbreaking situations. They prioritize minimizing risks and creating the right environment for children, who differ greatly from adults. For instance, the threshold to readmit a child is low. A child with a fever often triggers immediate return of the child to the hospital. Their jobs are demanding, needing to be in a state of constant readiness. I admire their passion for every patient.
Henry: Was there a pivotal moment in your career that led you to develop mechanical circulatory support systems?
Dr. Dasse: A surgeon who had trained at Texas Heart Institute arrived in Boston and invited me to join his team at Tufts University School of Medicine to participate in the animal studies for this new device called an LVAD. At the same time, the president of Boston University offered me a lab to do applied physiology instead of basic science. I jumped at the chance. Later, I headed up the surgical research at Tufts New England Research Center. My career was launched because of that surgeon’s invitation to join his team, and my passion for applied work – I wanted to harness what we learned to make a real difference.
Interview conducted by: Henry L. Mentzel, July 2025
