SAN RAMON, CA--(Marketwire - April 23, 2012) - BioVentrix, the developer of minimally invasive therapies for the treatment of heart failure, will release this week the six-month results of a 26-patient trial demonstrating safety and feasibility of its proprietary system for use in EpiCardial Ventricular Restoration (ECVR). Results from the trial indicate that the BioVentrix system is an impactful method of treating heart failure caused by scarring of the left ventricle (LV) from a previous heart attack. This innovative approach reduces the size of the enlarged LV and restores its conical shape, thereby improving cardiac function without the need for a ventriculotomy or cardiopulmonary bypass (CPB).
The abstract will be presented at the 61st European Society for Cardiovascular and Endovascular Surgery (ESCVS) International Congress, April 25-28, in Dubrovnik, Croatia.
"Our data confirm the safety and feasibility of this less invasive, beating heart, LV volume reduction and restoration procedure without the risks of a ventriculotomy or the need for cardiopulmonary bypass in many instances," said Andrew S. Wechsler, M.D., professor of Cardiothoracic Surgery at Drexel University College of Medicine in Philadelphia, Penn. "Across 25 patients that have reached the six-month follow-up window, LV end systolic volume was reduced by an average of 33 percent using the BioVentrix approach to decrease the circumference of the LV by excluding non-contractile scar tissue. In addition, the patients' quality of life (QOL) measures improved by nearly 36 percent and the standardized six minute walk test (6MWT) showed a 28% improvement.
"The magnitude of LV volume reduction is considerably greater than that achieved in the STICH trial, where LV volume was reduced by only 13 percent," continued Dr. Wechsler. "More importantly, it closely mirrors the results of numerous other observational studies of surgical ventricular reconstruction that have demonstrated the effectiveness of reducing LV size by scar exclusion for treatment of ischemic heart failure."
The ESCVS abstract highlights six-month results in 26 patients aged 37-74, with symptomatic heart failure, left ventricular dilation, anteroseptal scar, and ejection fractions (EF) from 13-to-44 percent. Significant LV volume reduction was accomplished in all 26 patients utilizing the BioVentrix system to appose the lateral LV wall against the ventricular septum using a series of paired anchors placed with transmural catheters. As the anchors are secured, the portion of the LV containing scar tissue is excluded from the rest of the contractile LV cavity, thereby restoring its normal volume and conical shape.
Post-procedure follow-up included serial echocardiograms to measure the function of the LV, six-minute walk tests, New York Heart Association Functional Class (NYHA FC) assessment, and quality-of-life (QOL) questionnaires at one, three and six months. All six-month measures showed significant improvement from pre-operative evaluation.
"These findings have very important implications for millions of heart failure patients, as existing therapies for this disease are limited and often ineffective," said Ken Miller, president and chief executive officer of BioVentrix. "Our technology may significantly expand treatment options for these patients to include a less invasive procedure without the need for cardiopulmonary bypass or surgically opening the ventricle, resulting in a considerably improved quality of life and the potential for extended survival."
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. This leads to reduced physical activity, loss of quality of life and decreased survival. Currently, open-heart surgical procedures are applied sparingly among such a fragile patient group due to its invasiveness. In Europe, nearly 40 percent of heart failure patients will die within one year of first hospitalization, and only 25 percent of men and 38 percent of women will survive more than five years following diagnosis(1,2).
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(3).
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 system offers 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.
(1) Blackledge HM, Tomlinson J, et al. Prognosis for patients newly admitted to hospital with heart failure: survival trends in 12 220 index admissions in Leicestershire 1993-2001. Heart 2003;89:615-620.
(2) Ho KK et al. Survival after the onset of congestive heart failure in Framingham Heart Study Subjects. Circulation 1993; 88:107-15.
(3) 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.