BioVentrix will be launching the Revivent Myocardial Anchoring system for use in less invasive ventricular enhancement (LIVE) procedures at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS, Barcelona, Spain, 27–31 October). The Revivent system is intended for patients suffering from ischaemic cardiomyopathy.
The company also announced that a clinical case demonstrating the efficacy of the novel Revivent system during a LIVE procedure will be presented at during the EACTS Techno-College Exhibition by Andrew S Wechsler, professor of Cardiothoracic Surgery at Drexel University College of Medicine in Philadelphia, USA, and Louis Labrousse, professor of Cardiovascular Surgery at Hopital Haut-Lévêque in Bordeaux-Pessac, France.
“The clinical case video that will be presented at Techno-College demonstrates the principal advantages of the Revivent technology. The procedure is performed without cardiopulmonary bypass, the heart is beating and stable, and there is no ventriculotomy,” said Wechsler. “Fluoroscopic control allows precise placement of the anchors that exclude the scarred segment of the ventricles and complete the restoration process. Intraoperative monitoring documents the excellent haemodynamics present at the end of the procedure without vasoactive support.”
The Revivent system facilitates the LIVE procedure, a pioneering advancement that reduces the size and improves the function of the left ventricle (LV) without an incision in the heart wall, or the need for cardiopulmonary bypass surgery. The innovative system reduces LV volume by excluding scarred myocardial tissue from the chamber, thereby reducing the harmful effects of high-tensile forces and increasing pumping efficiency. As a result, the ventricle is restored to its more optimal, conical geometry, resulting in enhanced performance of the remaining myocardium, and ultimately improving quality of life.
The new technology is also the topic of an oral abstract entitled,“Durability of Epicardial Ventricular Restoration without Ventriculotomy,” as well as several in-booth presentations during EACTS.
“Our innovative Revivent system used during LIVE procedures will help cardiac surgery teams ensure optimal clinical outcomes and improve the quality of life for heart failure patients with very minimal risk in comparison to conventional LV reconstruction surgery available today,” said Ken Miller, president and chief executive officer of BioVentrix. “Scientific literature suggests that existing treatment options, such as medication or pacemaker therapy, are not effective in over half of those treated, which exemplifies the need for minimally invasive cardiac surgery to treat the growing population of patients who suffer from heart failure.”
BioVentrix recently initiated a phase II, 50-patient study that will take place at up to 25 institutions throughout the European Union. The primary safety endpoint will be an assessment of the overall rate of serious adverse events during a 12-month follow-up period, and the primary efficacy endpoint will be assessment of a measurable decrease in LV volume by either an echocardiogram or a cardiac magnetic resonance exam at six months, and at one year. The study will broaden the clinical experience base amongst leading heart failure institutions and will expand awareness of the LIVE technique.
The BioVentrix system is an investigational device pending CE mark.