CE Mark For BioVentrix Revivent® Myocardial Anchoring System

In short

BioVentrix has received CE marking for its clever 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 what the company calls a “more optimal” volume and conical shape.

Background 

Traditional reshaping of the left ventricle, when required, is an invasive procedure known as surgical ventricular restoration (SVR). This involves stopping the beating heart and supporting it with cardiopulmonary bypass, while significant incisions into the heart muscle are made to excise the scarred, non-functioning (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 this patient population.

In contrast, the procedure known as Less Invasive Ventricular Enhancement™ (LIVE™) therapy is performed off-pump, the end-result looking something like a “tummy tuck” for the heart, the insertion of a row of clips effectively gathering up the slack created by heart failure induced ventricular enlargement.

Made possible by the Revivent system of anchors, the LIVE™ procedure can be performed as a separate stand-alone procedure, concurrent with other procedures or during other occasions when a sternotomy is already employed. Neither a myocardial incision nor cardiopulmonary bypass is required. The Revivent system is deployed using a straightforward, epicardial approach that can be completed in about one hour.
Physician comments

“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, 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.”

Company comments

“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 chief executive officer 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 (TCVR),” 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.”

Regulatory status

The Revivent™ Myocardial Anchoring System is not approved for sale in the United States.

Source: BioVentrix, Inc., Business Wire