In 2018, a transcatheter aortic valve implantation (TAVI) device replaced the diseased valve that was restricting blood flow to Isabelle’s heart, restoring normal function. Within a day of her minimally invasive surgery, she felt like a new woman. She no longer suffered from shortness of breath, poor sleep, or low energy, and she quickly returned to enjoying her normal life, “as if nothing happened,” she says.
Prior to the TAVI device, Isabelle would have had to endure open heart surgery – the standard treatment for her form of heart disease. According to interventional cardiologist Dr. Guy Leclerc, numerous factors would make this a great risk for Isabelle. Yet without intervention, her prognosis was poor, with only 1-3 years before she succumbed to her condition. Her attending physician at Centre Hospitalier de l’Universitė de Montrėal (CHUM), Jeannot Potvin, would agree with Dr. Leclerc that a TAVI was the best option for saving Isabelle’s life.
Fortunately, the TAVI, and revolutionary life-saving devices like them, are being developed and reaching patients like Isabelle through the work of forward-thinking med tech companies that are inventing solutions for numerous diseases. From heart valves to spinal growth rods to drug-eluting stents, medical devices are saving, extending, and improving our quality of life in ways we never had access to before these technologies arrived.
But bringing them to market is, in some ways, even more challenging than developing pharmaceutical therapies. Each requires a unique set of capabilities from surgical to therapeutic area expertise, and a deep knowledge of the regulatory conditions under which such devices can be approved. Beyond confirming they are an effective treatment for the disease indication, these devices must be proven safe to implant in the human body. And because they are created from a range of materials, each device is unique and often requires a custom testing plan. Clinical specialists who understand the disease state and the desired and potential outcomes of device therapy are the key to successful device development. Faced with these challenges, med tech companies often turn to contract research organizations that specialize in the medical devices.
Patients like Isabelle are the reason why Charles River is dedicated to serving the medical device industry with robust preclinical testing programs and therapeutic area expertise. Our state-of-the-art Boisbriand facility was proud to support the development of Isabelle’s TAVI device. Simultaneously serving patients at CHUM, Dr. Leclerc leads our Boisbriand team as the site’s Senior Director of Medical Devices and was part of the core team that worked on Isabelle’s device. He is energized by the capabilities our organization can contribute to the advances of medical device therapy. “With today’s nanotechnologies, 3D printing, artificial intelligence, we can now find solutions to diseases that could not be solved 5, 10 years ago.”
As a collaborator on the TAVI, fellow interventional cardiologist Dr. Potvin attests to the value that an organization like Charles River brings to the medical device development process. “By working in a rigorous environment like Charles River, the whole facility is so well-established and so well equipped, we could develop a model that eventually became the benchmark in the industry,” he says.