SAN RAMON, Calif. & VIENNA--(BUSINESS WIRE)--BioVentrix, a pioneer of technologies and procedures for less-invasive treatment of heart failure (HF), today announced the presentation of scientific data demonstrating the durability of its Revivent™ Myocardial Anchoring System in 24 patients one year post-procedure. These data, presented this week at the prestigious European Association for Cardio-Thoracic Surgery meeting in Vienna, Austria, by Dr. Andrew Wechsler, professor of cardiothoracic surgery at Drexel University (Philadelphia, Penn., USA), highlighted results from the Company’s Phase I clinical trial conducted at five European centers.
Twenty-four patients suffering from class II-IV HF, as defined by the New York Heart Association (NYHA) functional class criteria, as a result of a previous heart attack have now passed 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 data presented, 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
“Reaching the one-year milestone is enormously important in the world of heart failure treatment and clinical trials,” said Andrew S. Wechsler, M.D “When a significant percentage of patients are doing well at this juncture, it suggests that the technology will be durable and lasting in the general heart failure population. The results achieved with the Revivent System and the LIVE procedure are extremely encouraging, especially for the millions of patients suffering from heart failure worldwide who have become so frail due to their heart disease that they are no longer candidates for more invasive, conventional surgery.”
Prior to the Revivent System, reshaping of the left ventricle used an invasive procedure known as surgical ventricular reconstruction (SVR) to remove the scarred, non-functioning tissue created by a heart attack. The invasive nature of SVR limits its use because it requires stopping the patient’s heart and supporting it with cardiopulmonary (heart-lung) bypass while incisions into the heart muscle are made to remove the tissue. Placement of the Revivent System via the LIVE procedure obviates these requirements.
“The Revivent System is producing sustained results that significantly and positively impact the quality of our patients’ lives,” said Ken Miller, president and chief executive officer at BioVentrix. “The enthusiasm from clinicians is accelerating as are the number of LIVE procedures. Our next-generation product, the Revivent-TC System, will fuel this momentum by using a transcatheter technique and expanding use to the interventional catheterization laboratory.”
HF 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. This leads to limited physical activity, loss of quality of life and decreased survival.
Approximately 14 million people in Europe currently suffer from HF 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, more than 3.6 million new cases are reported each year in Europe and admission to hospitals with HF has more than doubled in the last 20 years. HF in Europe is more common than most cancers, including breast, testicular, cervical and bowel cancers.4
About the Revivent and the Revivent-TC Systems
The Revivent System received CE mark in December 2012 and clinical use has expanded from Eastern European clinical sites to major Western European markets including Germany, France, Portugal, Italy and the U.K. The system restores the LV to its more optimal conical shape by creating a fold of tissue that effectively excludes the non-functioning scar tissue created by a heart attack, thereby enhancing the efficiency of the remaining heart. The Revivent System is intended for use in the operating room as a stand-alone procedure or during a concurrent cardiac procedure. The Revivent-TC System, designed for use in the interventional laboratory, replicates the results of the Revivent System, but uses a hybrid transcatheter-minimally invasive technique and removes the need to open the patient’s chest.
About the LIVE Procedure: The World’s Only Reshaping Left Ventricle
The LIVE procedure is based upon a well-defined law of physics called the law of Laplace, which describes the relationship between the radius and pressure of the LV, and its resulting wall tension. Increased wall tension is the underlying cause of LV enlargement, worsening heart failure symptoms and ultimately patient death. Reducing wall tension is key to preventing further LV enlargement and treats the progression of the disease. The Revivent System, placed via the LIVE procedure, is uniquely designed to directly reduce the LV radius, which in turn decreases wall tension and interrupts the ongoing, destructive process of HF.
BioVentrix, a privately held medical technology company headquartered in San Ramon, Calif., is focused on developing and commercializing minimally invasive as well as nonsurgical therapies for treating HF.
NOTE: The Revivent Myocardial Anchoring System is approved for sale in Europe; it is not approved for sale in the United States. The Revivent-TC Myocardial Anchoring System is not yet approved for sale in Europe or in the United States.
1 Michler R et al. Insights from the STICH trial:
Change in left ventricular size after coronary artery bypass grafting
with and without surgical ventricular reconstruction. J of Thoracic
and Cardiovascular Surgery. 29 October 2012
2 Wechsler, A. et al, Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Abstract xx, XX annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.
4 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.