BioVentrix Receives CE Marking Certification for Revivent TC Heart Failure System

June 30, 2016 — BioVentrix Inc. announced that it has received certification for CE marking its Revivent TC TransCatheter Ventricular Enhancement System. Following a myocardial infarction or heart attack, the Revivent TC System implants proprietary micro-anchor pairs to exclude scarred myocardium from the healthy tissue of the left ventricle (LV). The restoration of the LV to a more optimal volume and conical shape has proven to enhance cardiac performance and significantly improve a patient's quality of life₁.

At two-year follow-up, patients have made remarkable improvements in their quality of life by 38 percent, according to BioVentrix. Additionally, the clinical benefit has been proven to extend life for patients with a significant reduction of LV end-systolic volume index (31 percent) and improvement of LV ejection fraction (23 percent)₂. Left ventricular volume reduction is especially critical for the survival of a patient as other studies have shown that significant LV volume reduction can directly prolong a patient's life₁. According to the company, the Revivent TC System is the only interventional therapy that can consistently achieve this survival benefit in heart failure patients. 

References

1. Michler R et al. Insights from the STICH trial: Change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J of Thoracic and Cardiovascular Surgery. 29 October 2012 (10.1016/j.jtcvs.2012.09.007).

2. Data available on file.

3. 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.