News | October 11, 2013

Promising Durability Data Presented for BioVentrix’s Heart Failure Treatment

Less-invasive procedure extends options for heart failure patients

heart failure treatments clinical trial/study bioventrix revivent LIVE

October 11, 2013 — Bioventrix announced the presentation of scientific data demonstrating the durability of its Revivent Myocardial Anchoring System in 24 patients one year post-procedure. The data, which Andrew Wechsler, M.D. and professor of cardiothoracic surgery, Drexel University, presented at the prestigious European Association for Cardio-Thoracic Surgery meeting in Vienna, Austria, highlighted results from the company’s Phase I clinical trial conducted at five European centers.

Twenty-four patients suffering from class II-IV heart failure (HF) — as defined by the New York Heart Association (NYHA) functional class criteria — as a result of a previous heart attack have now passed the one-year milestone since their HF was treated using the Revivent System via Less Invasive Ventricular Enhancement (LIVE) procedure. In the data presented, 24 of 26 patients sustained a reduction in left ventricle volume to a mean of 43.9 + 22 mL/m2 — a mean 40 percent decrease.[1] Additionally, quality-of-life scores increased 30.9 percent.

“When a significant percentage of patients are doing well at this juncture, it suggests that the technology will be durable and lasting in the general heart failure population,” said Andrew Wechsler, M.D. “The results achieved with the Revivent System and the LIVE procedure are extremely encouraging, especially for the millions of patients suffering from heart failure worldwide who have become so frail due to their heart disease that they are no longer candidates for more invasive, conventional surgery.”

The Revivent Myocardial Anchoring System is approved for sale in Europe; it is not approved for sale in the United States. The Revivent-TC Myocardial Anchoring System is not yet approved for sale in Europe or in the United States.

For more information:

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

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