News | January 03, 2013

BioVentrix Receives CE Mark for Myocardial Anchoring System

January 3, 2013 — BioVentrix announced it has received CE mark for its Revivent myocardial anchoring system, which makes possible Less Invasive Ventricular Enhancement (LIVE), a procedure that restores the left ventricle from damage done by a heart attack to a more optimal volume and conical shape, thereby enhancing performance of the heart’s non-damaged myocardium and improving quality of life.

Prior to Revivent, reshaping of the left ventricle required an invasive procedure known as surgical ventricular restoration (SVR), which required stopping the beating heart and supporting it with cardiopulmonary bypass while significant incisions into the heart muscle are made to excise the scarred, ischemic ventricular tissue. The invasive nature of SVR limits the number of patients for whom the procedure may be performed due to the fragile nature of the patient population. In contrast, the less invasive LIVE procedure using the Revivent system is performed without the need of cardiopulmonary bypass or making incisions into the heart.

“Heart failure in Europe is more common than most cancers,” said Louis Labrousse, M.D., professor of cardiovascular surgery at Hopital Haut-Lévêque, Bordeaux-Pessac, France. “Prior to the availability of Revivent, open heart surgery could only be applied sparingly among this very fragile patient population due to its invasiveness. There are some 14 million people in Europe who currently suffer from heart failure. Unfortunately, this number is expected to more than double by 2020. Thus, regulatory approval of Revivent is significant news for ischemic heart failure patients throughout Europe.”

“Because of Revivent, the LIVE procedure can be performed without cardiopulmonary bypass; therefore the heart is beating and stable, and there is no major surgical incision in the myocardium,” added Andrews S. Wechsler, M.D., professor of cardiothoracic surgery at Drexel University College of Medicine, Philadelphia. “Intraoperative monitoring has documented the excellent hemodynamics present at the end of the LIVE procedure without vasoactive support. No doubt, regulatory approval of Revivent will have a significant impact on the treatment of heart failure patients in Europe going forward.”

“Our innovative Revivent system used during LIVE procedures will empower cardiac surgery teams not only to ensure optimal clinical outcomes and enhance quality of life for heart failure patients, but also to minimize risk compared to the previous gold standard of conventional left ventricle reconstruction surgery,” said Kenneth Miller, president and CEO of BioVentrix.

“While we are extremely pleased with the regulatory approval of Revivent in Europe, we are also looking forward to our next-generation Revivent technology — transcatheter ventricular restoration,” added Miller. “Given the successful clinical outcomes we have achieved with Revivent, we have fast-forwarded development of our next-gen, endovascular technology designed to achieve the same results as the LIVE procedure, but with a sternal-sparing technique. This closed-chest, beating-heart transcatheter therapy is expected to be a new paradigm for treating heart failure patients, holding great promise for those who have suffered a heart attack but are just too sick to tolerate invasive heart surgery.”

The Revivent myocardial anchoring system is not approved for sale in the United States.

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