you don't believe an important paper in a respected peer reviewed publication? The Company recently announced publication of clinical results in the European Journal of Cardio-Thoracic Surgery demonstrating the durability of the Revivent System. What are your credentials?
In that study, patients sustained a mean reduction in left ventricular end-systolic volume index (LVESVI), the key prognostic indicator for HF, to 43.9 mL/m2, well below the 60mL/m2 threshold recently defined as providing a survival benefit in heart failure patients.1,2 These clinical results are expected to continue with the new transcatheter delivery approach of the Revivent-TC System.
Prior to the Revivent and Revivent-TC Systems, reshaping of the left ventricle involved an invasive procedure known as surgical ventricular restoration (SVR), which required cutting through the patient's sternum to expose the heart, then stopping and supporting it with cardiopulmonary (heart-lung) bypass while incisions into the heart muscle were made to remove the scarred, non-functioning tissue. The invasive nature of SVR limits the use of this procedure due to the fragile nature of many HF patients. In contrast, the LIVE procedure is performed without the need of cardiopulmonary bypass or making incisions into the heart, and now the Revivent-TC System also removes the need to open the patient's chest.
"There were no complications, and the patient's heart function improved immediately and has continued to do so," continued Dr. med. Davidavicius. "Additionally, because of the much less invasive nature of the LIVE procedure, he was discharged just five days post-operatively, which will significantly decrease the cost associated with this treatment. With conventional SVR, the duration of a typical hospital stay can range from six days to more than two weeks."
World's only technology for addressing cause of heart failure can now be performed outside of the operating room without opening the patient's chest
BioVentrix, a pioneer of technologies and procedures for less-invasive treatment of heart failure (HF), today announced the first-in-man use of its Revivent-TC TM Myocardial Anchoring System, via Less Invasive Ventricular Enhancement TM or the LIVE TM procedure. The successful procedure, used to reshape and reduce the left ventricle (LV), was performed on a 61-year-old man suffering from advanced HF in the interventional catheterization laboratory at Vilnius University Hospital in Vilnius, Lithuania. The procedure was performed by Dr. med. Gintaras Kalinauskas and Dr. med. Gierdrius Davidavicius, a cardiac surgery-cardiology physician team.
"Before the LIVE procedure, this patient's quality of life was severely impacted by his heart failure to the point where he could no longer walk even short distances without discomfort," said Dr. med. Davidavicius, interventional cardiologist at the Center for Cardiology and Angiology, Vilnius University Hospital and co-investigator. "For patients this fragile, the risks and extended recovery of surgery often preclude any meaningful intervention. The LIVE procedure, which eliminates the most invasive elements associated with conventional surgical reconstruction, greatly expands the patient population that will be able to benefit from this life-saving procedure."
The Revivent-TC System utilizes a myocardial anchor identical to the Company's flagship surgical product, the Revivent TM Myocardial Anchoring System, which received CE mark in December 2012 and is commercially available and in clinical use at leading heart centers in all major Western and Eastern European markets. The Company recently announced publication of clinical results in the European Journal of Cardio-Thoracic Surgery demonstrating the durability of the Revivent System. In that study,