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New hire has advised the company on its EMPOWER Trial of the Carillon Mitral Contour System.
March 22, 2024
By: Michael Barbella
Managing Editor
Renowned interventional cardiologist Satya Shreenivas, M.D., has joined Cardiac Dimensions as chief medical officer. Shreenivas brings his rich experience in both the clinical and commercial aspects of the structural heart landscape to his new role with the company. He led the structural heart program and cardiac catheterization laboratory at the University of Cincinnati and spent several years with The Christ Hospital in Ohio. There, he served as an investigator in many high-profile clinical trials, including several significant structural heart studies. Shreenivas is a frequent speaker at major scientific meetings and has been widely published in peer-reviewed journals across the structural heart, heart failure, and coronary arenas. He trained at the University of Pennsylvania and earned an MBA from the Wharton School. He served as chief medical officer for HLT Medical, a transcatheter heart valve company, as chief of Cardiology with Optum/United Health subsidiary SCA Health, and as medical director for clinical research organization Medpace. Shreenivas has been instrumental in advising Cardiac Dimensions on its EMPOWER Trial of the Carillon Mitral Contour System. “We are thrilled to welcome Dr. Shreenivas to Cardiac Dimensions and expect his valuable combination of clinical and industry experience, passion for evidence generation, and innovative spirit will benefit the EMPOWER Trial studying our Carillon device as a therapy for heart failure patients with functional mitral regurgitation,” Cardiac Dimensions CEO Rick Wypych said. “Having a structural heart leader like Satya as a member of the Cardiac Dimensions team will provide us with unique insights for our clinical research, as well as ongoing commercial efforts.” Many heart failure patients suffer from functional mitral regurgitation (FMR), which when left untreated, exacerbates their heart failure, further weakening the heart, degrading their quality of life, and reducing survival. The Carillon Mitral Contour System is designed to treat both FMR and heart failure in one short, minimally-invasive procedure. It is the only commercially available option for transcatheter mitral valve repair (TMVr) in Europe to consistently show favorable left ventricular remodeling while also acutely reducing FMR in clinical trials, according to Cardiac Dimensions. Carillon therapy is a right-sided approach that does not directly touch the mitral valve, allowing for any heart failure intervention a patient may require in the future. The device is designed to eliminate many of the risk-related requirements of other TMVr options—such as general anesthesia, procedural echo, transseptal puncture and patient medication changes—and has been shown in clinical trials to have substantially fewer procedural events than those reported by other therapies. Carillon therapy is included in heart failure treatment guidelines from the European Society of Cardiology and is fully reimbursed in Germany and several other European countries. “I’ve seen the compelling clinical evidence on Carillon therapy from Europe and look forward to helping the team expand the supportive body of evidence for this intriguing technology with the U.S. pivotal EMPOWER Trial,” Shreenivas stated. “I have always been energized by my work with emerging technologies that fill an unmet clinical need and am excited by the opportunity this therapy presents to enhance the lives of heart failure patients in a way that isn’t possible today.” The Carillon Mitral Contour System has obtained the CE Mark for NYHA Class II and greater patients, as well as Therapeutic Goods Approval (TGA), and is commercially available in Europe and Australia. It is considered an investigational device in the United States. Cardiac Dimensions develops minimally invasive therapy that reimagines the ways in which patients with heart failure and FMR can be treated and improved. Cardiac Dimensions maintains operations in Kirkland, Wash.; Sydney, Australia; and Frankfurt, Germany.
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