Viacor initiates treatment in heart failure study

Ptolemy-2 is an international, multi-center clinical trial designed to assess the safety and efficacy of the Viacor Percutaneous Transvenous Mitral Annuloplasty (PTMA) system in heart failure patients. The first Ptolemy-2 patient was treated by Rainer Hoffmann and Patrick Schauerte at the Universitatsklinikum Aachen of the Rheinisch-Westfalische Technische Hochschule in Aachen, Germany.

The Viacor PTMA system is designed to reduce symptomatic functional mitral regurgitation in heart failure patients. Utilizing an over-the-wire, fully percutaneous approach, the 7F PTMA system is composed of an implantable multi-lumen catheter with internally placed nitinol rods which re-shape the mitral annulus to improve anterior-posterior leaflet coaptation.

The PTMA system permits evaluation and optimization of therapeutic effect in-situ prior to permanent implantation, and remains fully retrievable thereafter via percutaneous subclavicular access.

The Ptolemy-2 study, which follows upon the successful completion of the Ptolemy-1 study in April, 2008, will treat up to 60 patients at investigational sites in Europe, Canada, and the US. Patients presenting with moderate-to-severe mitral regurgitation, New York Heart Association class II – IV and left ventricular ejection fraction between 25%-50% will be included.

Jonathan Rourke, president and CEO of Viacor, said: “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. 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.”