BioVentrix announced that the European Commission (EC) has extended the CE Mark approval of its Revivent TC Transcatheter Ventricular Enhancement System, up to May 2024.

The medical device firm has initially obtained the CE Mark for its Revivent TC Transcatheter Ventricular Enhancement System in 2016, for the treatment of heart failure. The approval allows the device to be marketed across the EU member nations.

Revivent TC System removes scar tissue on the left ventricle and improves blood flow

The less invasive ventricular enhancement (LIVE) therapy offered by the Revivent TC System is said to remove scar tissue on the left ventricle that occurred from a heart attack, facilitating the healthy portion of the heart operate effectively.

BioVentrix said that it has designed the implantable micro-anchors to bring the heart to a normal shape and size, resulting in reduced wall stress and improved blood flow to the body parts.

Percutaneous coronary intervention (PCI) is believed to be a standard of care for restoring blood flow to the heart after a heart attack, which includes a stent implant.

According to a study, 50% of patients treated with PCI are found to develop large LV scars, leading to dilated heart, and enlarged LVs are related with severe heart failure symptoms, higher mortality and more frequent re-hospitalization.

Also, positive remodelling of the heart is said to improve the LV function and reduce the heart failure symptoms, and surgical ventricular remodelling, a highly invasive procedure.

Headquartered in San Ramon, California, BioVentrix is engaged in the development of less invasive, catheter-based approaches to improve the treatments for congestive heart failure (CHF) caused by ischemic cardiomyopathy.

BioVentrix president and chief executive officer Kenneth Miller said: “The extension of our CE Mark is not only an important milestone for the company, but also validates the need for a novel therapy for patients with left ventricular dysfunction who are among the estimated 10 million people in the European Union suffering from heart failure.

“It ensures that physicians will continue to have an important, less invasive therapeutic option for these patients.”