16:11 - 27-06-2013 Persbericht

Eerste klinische patiënten met het BioVentrix Vevivent® System behalen verbetering van hartfunctie van 39,6% binnen een jaar

BioVentrix, pionier op het gebied van de Less Invasive Ventricular Enhancement™ procedure (LIVE™) voor de behandeling van hartfalen, kondigde vandaag de publicatie aan van de resultaten van de nulmeting en de vergelijking van de 12-maanden gegevens. Deze data bewijzen de duurzaamheid van haar Revivent Myocardial Anchoring System bij de eerste 11 patiënten die behandeld zijn met dit apparaat.

Zoals gepubliceerd in de European Journal of Cardio-Thoracic Surgery (EJCTS), is bij deze patiënten een gemiddelde verlaging te zien van de left ventriculair end-systolic volume index (LVESVI), de belangrijkste meting ter prognose van hartfalen, van 43.9 mL/m2. Dit valt ruim onder de onlangs vastgestelde veilige grens van 60mL/m2. Onder deze grenswaarde nemen de overlevingskansen van patiënten met hartfalen toe.

Het bedrijf heeft ook aangekondigd dat het aantal centra voor hartfalen, die getraind zijn in het werken met de LIVE procedure, is uitgebreid tot 20 toonaangevende centra door geheel West-Europa.

First BioVentrix Revivent® System Clinical Patients Sustain 39.6% Improvement in Heart Function at One Year

Data published in European Journal of Cardio-Thoracic Surgery demonstrates treatment durability; Company expands Western Europe training centers to 20

SAN RAMON, Calif. - (Business Wire)

BioVentrix, pioneer of the Less Invasive Ventricular Enhancement™ (LIVE™) procedure for the treatment of heart failure, announced today publication of baseline and 12-month comparative data demonstrating the durability of its Revivent Myocardial Anchoring System in the first 11 patients treated with the device. Published in the European Journal of Cardio-Thoracic Surgery (EJCTS), these patients sustained a mean reduction in left ventricular end-systolic volume index (LVESVI), the key prognostic measure for heart failure, to 43.9 mL/m2, well below the 60mL/m2 threshold recently defined as providing a survival benefit in heart failure patients.1,2 The Company also announced that the number of heart failure centers trained to perform the LIVE procedure has expanded to 20 leading centers throughout Western Europe.

“The extent of volume reduction achieved, and more importantly maintained at one year, using the Revivent System is comparable with, and in some cases exceeds, the results achieved in multiple clinical studies using a conventional surgical approach to reducing the volume of the left ventricle,” said Andrew S. Wechsler, M.D., professor of Cardiothoracic Surgery at Drexel University College of Medicine in Philadelphia, Penn., U.S.A. “These results demonstrate that effective volume reduction, using a less invasive approach, provides meaningful clinical benefit to a previously untreated, fragile patient population.”

Data from a recent subgroup analysis of the National Institute of Health (NIH)-sponsored Surgical Treatment for Ischemic Heart Failure (STICH) studyconcluded that reducing the volume of the left ventricle (LV) to less than 60mL/m2 provided a statistically significant improvement in survival for patients suffering from HF2. Since submission of data from the first 11-patients to EJCTS, an additional 15 patients have reached the crucial one-year survival mark. Combined these 26 patients treated with the Revivent System have maintained a mean LVESVI of 57.4mL/m2 for one year following the procedure, which represents a mean decrease of 33.5 percent.

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 the resulting LV wall tension. Increased wall tension is the underlying cause of LV enlargement, worsening heart failure symptoms and ultimately patient death. Conversely, reducing wall tension prevents further LV enlargement and stops the progression of the disease. The Revivent System is uniquely designed to reduce wall tension by directly reducing the LV radius, which in turn decreases wall tension and interrupts the ongoing destructive process of ischemic heart failure.

Phase I clinical trials, which led to CE-mark in November 2012, using the Revivent System were conducted at four European sites. A second broader phase now underway has brought system training to 20 additional sites, including several prominent heart failure centers in Germany and Italy.

“We are gratified to see the rapid expansion of the LIVE procedure across Europe, and the ease with which our clinicians are able to complete the required training for use of the Revivent System,” said Ken Miller, president and chief executive officer at BioVentrix, Inc. “We are equally pleased with the interest from the scientific community in our technology. Since our European product launch last November, the Revivent System has been highlighted in four different oral abstract presentations, all at prominent scientific meetings.”

About the Revivent System: A Less-Invasive Treatment for Heart Failure Patients

The Revivent™ Myocardial Anchoring System addresses the safety concerns of physicians about subjecting patients to invasive surgical interventions on the heart’s left ventricle. The Revivent system, placed using the LIVE™ procedure can be performed as a separate stand-alone procedure, concurrent with other procedures (e.g., CABG or transcatheter mitral valve procedures) or during other occasions when a sternotomy is already employed. Neither a myocardial incision nor cardiopulmonary bypass is required. Additionally, the Revivent system is deployed using a straightforward, epicardial approach that can be completed in about one hour.

About LIVE™: The World’s Only Reshaping, Restorative Left Ventricle Therapy

Less Invasive Ventricular Enhancement™ (LIVE™) therapy is an innovative off-pump (i.e., beating heart) procedure that helps restore the left ventricle’s intrinsic functional efficiency, rather than relying on a surrogate pumping device or other invasive treatment. The only therapy currently designed to restore optimal left ventricle size and function, LIVE provides physician teams with a gentler surgical option that enables them to more confidently treat heart failure patients who may not tolerate left ventricle incisions. LIVE bridges a need in available heart failure treatments, offering the potential for more consistent and favorable surgical outcomes, while giving heart failure patients and their families renewed hope for a more productive life.

About BioVentrix

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 heart failure (HF). The Revivent System received CE-mark in November 2012.

NOTE: The Revivent™ Myocardial Anchoring System requires regulatory approval and is not yet commercially available in the United States.

1Wechsler, A., et al. Durability of epicardial ventricular restoration without ventriculotomy. European Journal of Cardio-Thoracic Surgery (2013) 1–4. doi:10.1093/ejcts/ezt292

2Michler 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 (10.1016/j.jtcvs.2012.09.007).

Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

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