BioVentrix's Revivent TC Ventricular Enhancement Device Introduced in Germany
December 19, 2016—BioVentrix, Inc. announced the first Revivent TC transcatheter ventricular enhancement system procedure in Germany after the device received European CE Mark certification. The Less Invasive Ventricular Enhancement, or LIVE, procedure was performed by interventional cardiologists Christian Frerker, MD and Tobias Schmidt, MD, and by cardiothoracic surgeon Ralf Bader, MD, at Asklepios Klinik St. Georg in Hamburg, Germany.
The physicians implanted two anchor pairs and achieved a left ventricular (LV) volume reduction of 24%, which is a significant improvement for a patient with ischemic heart failure. By remodeling the LV to a more normal shape and size, the implant improves pumping efficiency, decreases wall stress, and immediately reverses patient symptoms.
BioVentrix, which is based in San Ramon, California, received European CE mark approval for the Revivent TC system in June. The device is used for plication of scar tissue after myocardial infarction in ischemic cardiomyopathy patients. The Revivent TC is not approved for sale in the United States.
In the BioVentrix announcement, Dr. Frerker commented, "We are pleased to be the first center in Germany to perform the Revivent TC procedure after CE Mark certification. The Revivent TC procedure continues to show significant clinical benefits to patients who suffer from ischemic cardiomyopathy postmyocardial infarction. It's a viable solution when guideline-directed medical therapy is not suitable."
Dr. Schmidt added, "The 24% volume reduction should directly impact the heart's pumping efficiency, which is a positive outcome for ischemic patients. That will result in an improvement in the patient's quality of life. This is the only minimally invasive technology which enables plication of scar tissue resulting in complete exclusion outside the LV cavity."
Also in the company's press release, Dr. Bader observed, "The Revivent TC procedure alleviates wall stress by the reshaping of the left ventricle and allowing for the heart to operate as it was intended to going forward. The immediate impact the Revivent TC procedure has on a patient is life-changing."