Published on September 29, 2012 at 2:39 AM Cardiac Dimensions®,Inc. this day announced that it has initiated its commercial efforts in Europe, treating the first patients with its CARILLON® Mitral Contour System® under its Conformite Europeenne (CE) Mark approval. The CARILLON system is a novel, minimally invasive therapy for treating heart patients suffering from functional mitral regurgitation (FMR). An estimated 70 percent of the 20 million people worldwide with heart failure also suffer from FMR.
As part of the commercial rollout, the patients have been enrolled in the PRIME (Percutaneous Repair in Functional Mitral Regurgitation) Study, a prospective, multicenter post-market study registry that builds on the clinical experience from Cardiac Dimensions’ AMADEUS, TITAN and TITAN II studies. Long-term safety and efficacy will be evaluated in the PRIME study through the assessment of hemodynamics, functional capacity, heart failure hospitalizations as well as quality of life in up to 300 patients.
To support commercial efforts, Cardiac Dimensions has established direct operations in Europe, including a dedicated sales and clinical team focused exclusively on the successful rollout of the CARILLON system.
“Initiation of commercial sales represents a major milestone for Cardiac Dimensions,” said Rick Stewart, Chief Executive Officer. “We have spent the last few months preparing our organization for successful training, sales, distribution and clinical support of the CARILLON technology and are receiving a very warm reception from our early doctor customers. In addition to general excitement around the minimally invasive CARILLON treatment, our doctors have also expressed a strong interest in participating in additional clinical studies. With the compelling outcomes expressed in TITAN and early positive signals coming from TITAN II, this bodes well as we start the PRIME study.”
SOURCE Cardiac Dimensions, Inc.
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Submited at Saturday, September 29th, 2012 at 8:15 am on Uncategorized by Gillan
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