Viacor, a US privately-held company focused on the development of percutaneous therapies for cardiac valve repair, has treated the first patient in the PTOLEMY-2 study of its percutaneous transvenous mitral annuloplasty system in people with heart failure.
PTOLEMY-2 is an international, multicenter, 60-patient, safety and efficacy trial, which follows on the successful completion of the PTOLEMY-1 study in April. Patients presenting with moderate-to-severe mitral regurgitation, NYHA class II-IV and left ventricular ejection fraction between 25%-50% will be included.
"Viacor has taken a methodical approach to the development and early clinical evaluation of the PTMA system to ensure that it is ready for routine use in a clinical setting," said chief executive Jonathan Rourke. "Prioritizing patient safety, ensuring applicability across a broad spectrum of patients and striving to create a device which is easy to use in a conventional cardiac cath lab setting were all design goals of the PTMA system, which I am confident we have now achieved," he added.
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