BioVentrix expands use of its Revivent System for heart failure treatment with first clinical procedure in Germany

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BioVentrix has announced the successful first use of its Revivent Myocardial Anchoring via Less Invasive Ventricular Enhancement (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 Ralph Haberl, professor of Internal Medicine and Cardiology at the University of Munich, Germany, 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, Haberl implanted an automatic internal cardioverter defibrillator as a palliative treatment for ventricular tachycardia. 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 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 Schütz. “The entire procedure was uncomplicated, the patient was extubated the same day and he continues to do very well.”

During the postoperative evaluation, 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 Haberl.

The LIVE procedure, according to a company release, 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 left ventricle, and its resulting wall tension. Increased wall tension is the underlying cause of left ventricle enlargement, worsening heart failure symptoms and ultimately patient death. It was said in the release that the Revivent System is designed to directly reduce the left ventricle radius, which in turn decreases wall tension and interrupts the ongoing, destructive process of heart failure.

“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 systemic vascular resistance.

“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 catheterisation laboratory.”