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Devices Cardiology

 News Release - August 13, 2013

BioVentrix Expands Use of Its Revivent(TM) System for Heart Failure Treatment with First Clinical Procedure in Germany

Less invasive treatment reshapes the left ventricle of patient too fragile to undergo conventional surgical reconstruction

SAN RAMON, Calif. & MUNICH--(Healthcare Sales & Marketing Network)--BioVentrix, a pioneer of technologies and procedures for the less-invasive treatment of heart failure (HF), today announced the successful first-use of its Revivent™ Myocardial Anchoring System, via Less Invasive Ventricular Enhancement™ or the LIVE™ procedure in Germany. The successful procedure was performed on a 54-year old man suffering from advanced heart failure at the Schön Klinik Vogtareuth in Vogtareuth, Germany.

“As a result of a heart attack, this patient suffered from heart failure for two years, that despite intervention with coronary angioplasty and medication, continued to worsen and seriously affected his quality of life,” said Prof. Dr. med. Ralph Haberl, Professor of Internal Medicine and Cardiology at the University of Munich, and the patient’s private cardiologist. “The patient was critically ill and had exhausted all other available treatment options.”

As part of the patient’s previous treatment Prof. Haberl implanted an automatic internal cardioverter defibrillator as a palliative treatment for ventricular tachycardia, an abnormal life-threatening heart rhythm that often results after a heart attack in which a large amount of scar tissue is created. Magnetic Resonance Imaging (MRI) of the heart, demonstrated an ejection fraction of only 12% and significant damage, including scar tissue that extended to the septum and the anterior left ventricular wall. An interdisciplinary team led by Prof. Dr. med. Albert Schütz, Chief of Heart Surgery at the Schön Klinik Vogtareuth, performed the LIVE procedure.

“The Revivent System was successfully placed using the LIVE procedure, which removes the need for cardiopulmonary bypass and, unlike conventional volume-reduction surgery, does not require an incision into the heart,” said Prof. Schütz. “The entire procedure was uncomplicated, the patient was extubated the same day and he continues to do very well.”

During the postoperative evaluation, Prof Haberl and his team noted an immediate decrease in left ventricular end system volume index (LVESVI), a predictive indicator of survival for heart failure patients, from 289mL/m2 to 98mL/m2, and an increase in ejection fraction to 33%. “The LIVE procedure should be considered as a promising treatment option in severe heart failure after myocardial infarction,” said Prof. Haberl.

During a heart attack the portion of the left ventricle (LV) deprived of blood dies creating a scar that 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. 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 is uniquely designed to directly reduce the LV radius, which in turn decreases wall tension and interrupts the ongoing, destructive process of heart failure.

Prior to the Revivent System, reshaping of the left ventricle used an invasive procedure known as Surgical Ventricular Restoration (SVR), which required stopping the beating heart and supporting it with cardiopulmonary bypass, while incisions into the heart muscle were made to remove the scarred, non-functioning LV tissue. The invasive nature of SVR limits the number of patients for whom the procedure may be performed due to the fragile nature of this patient population. In contrast, the LIVE procedure using the Revivent System is performed without the need of cardiopulmonary bypass or making incisions into the heart.

“We are very pleased with the adoption of the Revivent System and the LIVE procedure by the cardiac surgery team in Germany,” said Kenneth Miller, president and chief executive officer of BioVentrix. “We believe that our technology not only secures optimal clinical outcomes and improves the quality of life for heart failure patients, but also diminishes the risk inherent in the previous gold standard of conventional SVR.

“We continue to further evolve the Revivent technology and are making great progress in the development of Revivent-TC™, a hybrid transcatheter-minimally invasive approach to the LIVE procedure,” continued Miller. “It is designed to replicate the same outstanding clinical results as the Revivent System; however, this approach will remove the need to open the patient’s chest and will allow the procedure to be performed in the interventional catheterization laboratory.”

About the Revivent System: A Less Invasive Intervention 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 system is comprised of a series of titanium anchor pairs, each consisting of an internal and an external anchor, which are placed using transmural catheters. Once the desired number of anchor pairs is positioned, a force gauge is used to guide deployment, pulling 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. The ventricle is restored to a more optimal, conical shape, which enhances the performance of the remaining myocardium. The Revivent System is deployed using a straightforward, epicardial approach that can be completed in about one hour.

About the LIVE Procedure: The World’s Only Reshaping, Restorative Left Ventricle Therapy Less Invasive Ventricular Enhancement therapy is an innovative, new off-pump (i.e., beating heart) procedure that helps restore the LV’s native functional efficiency, rather than relying on a surrogate pumping device or other invasive treatment. The LIVE procedure provides physician teams with a gentler surgical option, offering the potential for more consistent and favorable surgical outcomes, while giving HF patients and their families renewed hope for a more productive life. The LIVE procedure can be performed as a separate stand-alone procedure, concurrent with other procedures (e.g., CABG) or during other occasions when a sternotomy is already employed. Neither a myocardial incision nor cardiopulmonary bypass is required.

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.

Source: BioVentrix

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