FOSTER CITY, Calif., July 6 /PRNewswire/ -- Ample Medical, Inc., a global technology leader in the percutaneous repair of mitral valve regurgitation associated with congestive heart failure (CHF), announced today that the first human implants of its PS3 System(TM) took place on June 14, 2006. The two successful implants, performed at University Hospital in Caracas, Venezuela mark the initiation of the clinical phase for the PS3 System.
The PS3 System was implanted in two patients prior to open heart surgery then removed during the surgical procedure. In both patients, the intended surgical intervention included repair of the mitral valve with an annuloplasty ring. The innovative procedure was performed by an experienced medical team including Igor Palacios, MD (Massachusetts General Hospital, Boston, Massachusetts), Victor Rodriguez, MD (University Hospital), Jose Condado, MD (Centro Medico, Caracas, Venezuela), Fernando Bosch, MD (University Hospital), and Gaston Silva, MD (University Hospital). Jason Rogers, MD and Reginald Low, MD (both University of California, Davis, California) consulted throughout the procedures.
Delivery and deployment of the PS3 System utilizes standard interventional cardiology techniques well known to practitioners. The percutaneous, endovascular delivery and deployment of the PS3 System took less than 90 minutes using only fluoroscopic guidance. "The delivery and deployment of the PS3 System went very smoothly . . . consistent with standard interventional therapies," commented Dr. Jason Rogers, Assistant Clinical Professor Cardiovascular Medicine, Interventional Cardiology at the University of California, Davis.
After deployment, the PS3 System continued to perform flawlessly in both patients before removal during the subsequent surgical procedure. The system is configured to reshape the mitral valve annulus across the critical septal-lateral diameter resulting in amelioration of the mitral valve regurgitation safely and effectively. "The PS3 System effectively reduced the septal-lateral diameter in both patients resulting in up to a three grade reduction in mitral regurgitation," explained Dr. Igor Palacios, Director of Interventional Cardiology and the Cardiac Catheterization Laboratories at Massachusetts General Hospital.
The PS3 System underwent extensive pre-clinical testing in preparation for these studies. The pre-clinical work was pivotal in finalizing the component design and delivery procedure as well as serving as an effective training experience for the medical team. Dr. Reginald Low, Professor of Medicine and Chief of the Division of Cardiovascular Medicine at the University of California, Davis, added, "The tremendous success in the first two clinical patients duplicates the results achieved in pre-clinical studies where the safety and efficacy of the PS3 System was established in both ovine and porcine models."
The PS3 System is an investigational device for the percutaneous endovascular repair of CHF-related mitral valve regurgitation. The successful First-In-Man implants represent a significant milestone in the development and commercialization of the system. The company looks forward to quickly advancing this technology to help the many patients suffering from this condition.
Ample Medical, Inc. designs, develops and manufactures endovascular medical devices for repairing heart valves. It is a privately held company based in Foster City, CA.
Ample Medical, Inc.