BioVentrix is a privately held medical device company headquartered in San Ramon, CA, USA. Our mission is to improve and expand the treatment available of congestive heart failure (CHF) caused by ischemic cardiomyopathy, through the development of less invasive, catheter-based approaches.
BioVentrix provides physicians with innovative technology that corrects the anatomical damage created by CHF to slow the progression of this debilitating and fatal disease.
To this end, our surgical product, the Revivent™ Myocardial Anchoring System, improves cardiac function by restoring the size, volume and resulting function of the left ventricle (LV) in heart failure patients. These results are achieved through a novel procedure known as Less Invasive Ventricular Enhancement™ (LIVE™). LIVE therapy excludes the scarred, non-functioning portion of the LV to improve LV efficiency in the CHF patient, thus enhancing quality of life.
BioVentrix achieved its first-in-man (FIM) milestone in August 2010, performed on a 52-year-old male heart failure patient in Krakow, Poland. Subsequent to implantation of the Revivent System, the patient’s heart size was decreased by 28 percent, while ejection fraction (EF) increased by 9 percent.
More recently, data published in 2013 in the prestigious European Journal of Cardio-Thoracic Surgery, highlighted results from the Company's Phase I clinical trial, including durability data. Twenty-four patients suffering from class II-IV ischemic HF, reached the one-year milestone since their HF was treated using the Revivent System via Less Invasive Ventricular Enhancement™ or the LIVE™ procedure. A key indicator for survival in HF patients lies in reducing and maintaining the volume of the left ventricle (LV) to less than 60mL/m2.1 In the published data, 24 of 26 patients sustained a reduction in this critical prognostic measure to a mean of 43.9 + 22 mL/m2, a mean 40 percent decrease.2 Also reported was a 30.9 percent improvement in quality-of-life (QOL) scores, which measure psychological and physical aspects that greatly influence a patient’s independence.3
Given the promising results achieved with the Revivent System, BioVentrix rapidly developed a transcatheter, endovascular product - the Revivent TC™ TransCatheter Ventricular Enhancement System - that is intended to achieve the same results, but in an even less invasive manner. In addition to removing the need for cardiopulmonary bypass or placing incisions directly into the heart muscle, Revivent TC also eliminates opening the patient's chest via a sternotomy, often the most painful part of cardiac surgery for patients in the post-operative period. The Revivent TC System, the world's only technology for addressing the cause of heart failure can now be performed outside of the operating room, is currently in clinical trials at several European centers.