European Commission has extended CE Mark for US-based firm BioVentrix ’s Revivent TC Transcatheter Ventricular Enhancement System, until May 2024.
The company initially secured the CE Mark for its heart failure treatment system in 2016.
The CE marks allows devices to be marketed across EU member nations.
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.”
The less invasive ventricular enhancement (LIVE) therapy employs the Revivent TC to remove scar tissue on the left ventricle that occurred due to a heart attack, allowing the healthy portion of the heart to operate.
BioVentrix stated that the micro-anchors are designed and implanted so that the heart can be made to a natural shape and size, leading to less wall stress and healthier blood flow to body parts.
Percutaneous coronary intervention (PCI) is 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 were found to develop considerable LV scars, leading to a dilated heart. Enlarged LVs are related to severe heart failure symptoms, higher mortality and frequent re-hospitalisation.
Positive remodelling of the heart has indicated to improve the LV function and reduce heart failure symptoms.
In November, BioVentrix had secured Breakthrough Device Designation status from the US Food and Drug Administration (FDA) for its Revivent TC Transcatheter Ventricular Enhancement System to treat heart failure.