BARCELONA, SPAIN--(Marketwire - October 25, 2012) - Techno-College Booth 005; EACTS Booth 92/93 - BioVentrix, the developer of minimally invasive heart failure therapies, today introduced the Revivent™ Myocardial Anchoring system for use in Less Invasive Ventricular Enhancement™ (LIVE™) procedures. The Revivent system is intended for patients suffering from ischemic cardiomyopathy and will be showcased at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS), Oct. 27-31, 2012.
The company also announced that a clinical case demonstrating the efficacy of the novel Revivent system during a LIVE procedure will be presented by Andrew S. Wechsler, M.D., professor of Cardiothoracic Surgery at Drexel University College of Medicine in Philadelphia, Penn., U.S.A., and Louis Labrousse, M.D., professor of Cardiovascular Surgery at Hopital Haut-Lévêque in Bordeaux-Pessac, France. The presentation will occur on Oct. 27 at 15:30 CET during the EACTS Techno-College Exhibition.
According to Dr. Wechsler, "The clinical case video that will be presented at Techno-College demonstrates the principal advantages of the Revivent technology. The procedure is performed without cardiopulmonary bypass, the heart is beating and stable, and there is no ventriculotomy.
"Fluoroscopic control allows precise placement of the anchors that exclude the scarred segment of the ventricles and complete the restoration process. Intraoperative monitoring documents the excellent hemodynamics present at the end of the procedure without vasoactive support," continued Dr. Wechsler.
The Revivent system facilitates the LIVE procedure, a pioneering advancement that reduces the size and improves the function of the left ventricle (LV) without an incision in the heart wall, or the need for cardiopulmonary bypass surgery. The innovative system reduces LV volume by excluding scarred myocardial tissue from the chamber, thereby reducing the harmful effects of high-tensile forces and increasing pumping efficiency. As a result, the ventricle is restored to its more optimal, conical geometry, resulting in enhanced performance of the remaining myocardium, and ultimately improving quality of life.
The new technology is also the topic of an oral abstract entitled, "Durability of Epicardial Ventricular Restoration without Ventriculotomy," as well as several in-booth presentations during EACTS.
"Our innovative Revivent system used during LIVE procedures will help cardiac surgery teams ensure optimal clinical outcomes and improve the quality of life for heart failure patients with very minimal risk in comparison to conventional LV reconstruction surgery available today," said Ken Miller, president and chief executive officer of BioVentrix. "Scientific literature suggests that existing treatment options such as medication or pacemaker therapy, are not effective in over half of those treated, which exemplifies the need for minimally invasive cardiac surgery to treat the growing population of patients who suffer from heart failure."
BioVentrix recently initiated a Phase II, 50-patient study that will take place at up to 25 institutions throughout the European Union. The primary safety endpoint will be an assessment of the overall rate of serious adverse events during a 12-month follow-up period, and the primary efficacy endpoint will be assessment of a measurable decrease in LV volume by either an echocardiogram or a cardiac magnetic resonance (CMR) exam at six months, and at one year. The study will broaden the clinical experience base amongst leading heart failure institutions and will expand awareness of the LIVE technique.
Heart Failure is a widespread disease with symptoms that include shortness of breath, exercise intolerance, swelling of the ankles from fluid retention and general fatigue caused by the inability of the heart to pump blood efficiently to meet the demands of the body. Currently, open-heart surgical procedures are applied sparingly among such a compromised patient group due to its invasiveness. Approximately 14 million people in Europe currently suffer from heart failure and this number is expected to increase to 30 million by the year 2020, according to the Study Group on Heart Failure Awareness and Perception in Europe (SHAPE). In addition, over 3.6 million new cases are reported each year in Europe and admission to hospitals with heart failure has more than doubled in the last 20 years. Heart failure in Europe is more common than most cancers, including breast, testicular, cervical and bowel cancers(1).
BioVentrix is a privately held medical device company headquartered in San Ramon, Calif. U.S.A. Its mission is to improve and expand on the treatment of heart failure, primarily through the development of less invasive, catheter-based approaches. The company's proprietary systems are designed to offer a less invasive, accelerated recovery treatment that improves cardiac function by restoring the geometry and resulting function of the left ventricle, thereby improving a patient's quality of life. The company's clinical investigators include some of the world's leading surgeons and cardiologists. The BioVentrix system is an investigational device pending CE Mark. For more information, please visit: http://bioventrix.com.
Revivent and LIVE are trademarks of BioVentrix, Inc.
(1)Stewart S et al. More malignant than cancer? Five year survival following a first admission for heart failure. The European Journal of Heart Failure 2001; 3:315-322.