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BioVentrix Reports First Italian Clinical Cases With Revivent™ System for Less-Invasive Heart Failure Treatment



10/4/2013 8:25:51 AM

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SAN RAMON, Calif., and BRESCIA, Italy, Oct. 3, 2013 — BioVentrix, a pioneer of technologies and procedures for less-invasive treatment of heart failure (HF), today announced the successful clinical use of its Revivent™ Myocardial Anchoring System, via Less Invasive Ventricular Enhancement™ or the LIVE™ procedure in three clinical procedures all conducted in the same week by Professor Claudio Muneretto, director of the department of cardiac surgery, the Ospedale Civile, in Brescia, Italy. The successful procedures, used to reshape the left ventricle (LV), were performed on three patients, all men ages 68-77 years, suffering from advanced HF.

“These patients were all experiencing a very poor quality of life before the LIVE procedure,” said Professor Muneretto. “Immediately after the procedure, the volume of the left ventricle of each patient was reduced by 25-35 percent, and importantly, the procedures were performed without complications. The LIVE procedure and Revivent System provide a much-needed option for patients suffering from heart failure, particularly when medical therapy is no longer effective.”

Prior to the Revivent System, reshaping of the left ventricle used an invasive procedure known as surgical ventricular reconstruction (SVR), which required stopping the patient’s heart and supporting it with cardiopulmonary (heart-lung) bypass while incisions into the heart muscle were made to remove the scarred, non-functioning tissue. The invasive nature of SVR limits the use of this procedure due to the fragile nature of many HF patients. In contrast, the LIVE procedure using the Revivent System is performed without the need of cardiopulmonary bypass or making incisions into the heart.

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. As commercial operations have increased, so has exposure within the clinical community. Indeed, the Revivent System will be the subject of an oral abstract presentation by Dr. Andrew Wechsler (Drexel University, Philadelphia, PA) at the 27th annual meeting for the European Association for Cardio-Thoracic Surgery in Vienna, Austria Monday, Oct. 7, 2013. This marks the tenth scientific presentation about the Revivent System since it received CE mark.

“As we transition from a clinical to a commercial stage company, we are realizing our goal of expanding the use of the only treatment approach that addresses the underlying cause of heart failure,” said David Schickling, vice president of sales and marketing at BioVentrix. “While clinical adoption of the Revivent System continues to grow, our forthcoming Revivent-TC product, a hybrid transcatheter approach, will enable even more patients to benefit from this technology.”

Ischemic HF, the most common form of HF, develops after a heart attack creates a scar in the LV. This scarred tissue does not contract along with the rest of the LV, and prevents it from efficiently pumping blood to the body. As the volume-overloaded LV enlarges, HF develops and worsens, severely impairing quality of life. According to the European Journal of Heart Failure, it is estimated that the prevalence of HF in Europe stands at 6.5 million people and is rising because of the aging global population.1

About the Revivent-TC and the Revivent Systems

The Revivent-TC and Revivent Myocardial Anchoring Systems address the safety concerns of physicians about subjecting patients to invasive surgical interventions on the LV of the heart. The system, comprised of a series of titanium anchor pairs placed using transmural catheters, pulls the lateral LV wall toward the septum to create a fold of tissue that effectively excludes the non-functioning scar created by a previous heart attack. This restores the LV to a more optimal, conical shape, which enhances the pumping efficiency of the remaining myocardium. The Revivent-TC System is designed for use in the interventional laboratory whereas the Revivent System is for use in the operating room when the patient’s chest has been opened for a concurrent cardiac procedure.

About the LIVE Procedure: The World’s Only Reshaping Left Ventricle Therapy

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 heart failure.

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 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.

1McMurray JJV, Stewart S. The burden of heart failure. European Heart Journal 2003;5(Suppl.):I3–I13.

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