Source: BioVentrix

BioVentrix continues to expand the use of its transcatheter heart failure treatment with first closed chest procedure in France



BioVentrix continues to expand the use of its transcatheter heart failure treatment with first closed chest procedure in France

Implant of Revivent-TC™ Ventricular Enhancement System brings less invasive treatment to hybrid suite

SAN RAMON, Calif., and Bordeaux, France, May 20, 2014 — BioVentrix, a pioneer of technologies and procedures for less-invasive treatment of heart failure (HF), today announced the successful first clinical use in France of its closed-chest Revivent-TC™ Ventricular Enhancement System. The Less Invasive Ventricular Enhancement™ or the LIVE™ procedure, utilizing this new transcatheter approach, is in clinical trials throughout Western Europe. The transcatheter hybrid procedure, used to reshape the left ventricle (LV) to improve pumping efficiency and reduce wall stress, was performed by Prof. Louis Labrousse and Dr. Lionel Leroux at Hôpital Haut-Lévèque in Bordeaux-Pessac France and was successfully implanted in a 70-year-old man suffering from ischemic heart failure.

“We are impressed by the immediate impact the less-invasive Revivent-TC hybrid system had on our patient,” said Professor Louis Labrousse, M.D., Professor of Cardiovascular Surgery. “The patient achieved a nearly 50% reduction in LVESVI post-op with an unremarkable recovery, no complications, and was discharged from the ICU after only two days. The therapy gives renewed hope to patients who suffer from ischemic heart failure by providing clinical benefits that cannot be achieved with optimal medical therapy (OMT) alone.”

“By decreasing the excessive volume without having to open the patient’s chest and without the use of cardiopulmonary bypass, more patients will have the opportunity to benefit from this intervention,” added Dr. Lionel Leroux, Interventional Cardiologist.  “This hybrid procedure may be the medical breakthrough needed to treat the underlying cause of heart failure.  We are very pleased with the outcome of this procedure and look forward to our continued partnership with BioVentrix to offer this therapy to our patients.”

The Revivent-TC System utilizes a myocardial anchor identical to the Company’s flagship surgical product, the Revivent™ Myocardial Anchoring System, which is commercially available and in clinical use at leading heart centers throughout Europe. The Company recently announced that their transcatheter technology and clinical results will be discussed in a sponsored symposium at the 2014 EuroPCR Congress in Paris entitled “Transcatheter treatment of ischaemic heart failure: the Less Invasive Ventricular Enhancement™ (LIVE™) procedure using the Revivent™ Myocardial Anchoring System.” The symposium will take place on May 21, 2014 from 12:30-13:30 in Room 353.  To register for the symposium and to hear a two-minute preview from the chairman and other faculty, please click here.  BioVentrix will also exhibit the Company’s latest technology in stand number M42 and have multiple oral presentations highlighting this novel technology throughout the EuroPCR scientific sessions.

About the Revivent System and the LIVE Procedure
Placement of the Revivent System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a catheter-based approach. The anchors are then pulled toward one another, effectively excluding the scarred and non-functioning heart wall. The efficiency of the remaining heart muscle is immediately improved, by as much as 30-40 percent.[i] Presentation of recent scientific data indicates that in 92 percent of patients, the efficacy results were durable beyond one year.[ii]

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[i] Wechsler, A. et al, Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.

[ii] Ibid.