WILMINGTON, Mass., Nov. 14 /PRNewswire/ -- Viacor, Inc., a privately held company focused on the development of percutaneous therapies for cardiac valve repair, announced today that the first patient in the PTOLEMY-2 (Percutaneous TransvenOus Mitral AnnuloplastY) study has recently been successfully treated. PTOLEMY-2 is an international, multi-center clinical trial designed to assess the safety and efficacy of the Viacor PTMA(R) (Percutaneous Transvenous Mitral Annuloplasty) system in heart failure patients.
The first PTOLEMY-2 patient was treated by Rainer Hoffmann, MD, PhD and Patrick Schauerte, MD at the Universitatsklinikum Aachen of the Rheinisch-Westfalische Technische Hochschule in Aachen, Germany. "We are delighted to have treated the first patient in the PTOLEMY-2 study," said Prof. Hoffmann, Director of Interventional Cardiology in Aachen. "We were very pleased with the precision of the procedure and look forward to enrolling more patients."
Stefan Sack, MD, PhD, Chief of Cardiology, Pneumology and Intensive Care at the Stadtisches Klinikum Munchen in Munich, Germany and Principal Investigator of the PTOLEMY-2 study added, "As is being demonstrated with percutaneous aortic valve implantation, a percutaneous approach to mitral valve repair may soon become an important, less-invasive treatment option in appropriate patients."
The Viacor PTMA(R) system is designed to reduce symptomatic functional mitral regurgitation in heart failure patients. Utilizing an over-the-wire, fully percutaneous approach, the 7F PTMA(R) 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(R) system permits evaluation and optimization of therapeutic effect in-situ prior to permanent implantation, and remains fully retrievable thereafter via percutaneous subclavicular access.
"Viacor has taken a methodical approach to the development and early clinical evaluation of the PTMA(R) system to ensure that it is ready for routine use in a clinical setting," said Jonathan M. Rourke, President and CEO of Viacor, Inc. "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(R) system which I am confident we have now achieved. We remain grateful to our clinical investigators worldwide, many of whom have worked with us for more than six years, for their contributions and continuing collaboration."
An estimated 20 million people suffer from heart failure worldwide, with at least 15% exhibiting moderate-to-severe mitral regurgitation. Over 2 million new patients are diagnosed with heart failure every year in Europe, Canada and the United States.
In heart failure patients, mitral regurgitation contributes to a progressively deteriorating course of volume overload, decreased left ventricular function, and worsening heart failure symptoms. As the heart expands, the annulus of the mitral valve expands with it, preventing normal coaptation of the mitral valve leaflets, resulting in the regurgitation of blood from the left ventricle to the left atrium. Current treatment alternatives include palliative medical management of the symptoms and surgical correction of the valve involving cardio-pulmonary bypass and lengthy recovery times. Due to advanced age or other medical conditions, many heart failure patients with mitral regurgitation are not candidates for surgical intervention.
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 United States. Patients presenting with moderate-to-severe mitral regurgitation, NYHA class II - IV and left ventricular ejection fraction between 25% - 50% will be included.
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