BioVentrix said today it enrolled the 1st US patient in a pivotal clinical trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients with heart failure symptoms related to cardiomyopathy. The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of […]
BioVentrix
BioVentrix wins FDA IDE nod, launches Revivent TC trial
BioVentrix said today it received FDA investigational device exemption approval and launched a safety and efficacy trial of its Revivent TC transcatheter ventricular enhancement system designed to treat patients suffering from ischemic cardiomyopathy. The Revivent system is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small […]
BioVentrix raises $15m
BioVentrix raised $14.5 million in a new round of equity financing according to an SEC filing posted this week. Funds in the round came from 152 unnamed investors, with the 1st sale marked on July 21, 2016, according to the filing. The company is not seeking anymore funds the round. The company raised the money […]
BioVentrix touts 1st clinical use of Revivent for ischemic cardiomyopathy
BioVentrix said yesterday that its Revivent TC transcatheter ventricular enhancement system saw its 1st clinical use in treating ischemic cardiomyopathy at Berlin, Germany’s Deutsches Herzzentrum. The device was used by interventional cardiologist Dr. Cristoph Klein and Dr. Felix Hennig, with assitance from Dr. Sebastian Kelle, according to BioVentrix. The Revivent system is designed to eliminate the […]
BioVentrix launches Revivent TC in China
BioVentrix said today it launched its Revivent TC transcatheter ventricular enhancement system in China, and that the device has been used in its 1st commercial procedure in the region. The Revivent system designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium anchors along the heart’s outer […]
BioVentrix lands German reimbursement win for Revivent system
BioVentrix said today that its Revivent TC transcatheter ventricular enhancement system won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System. This status is the highest of 4 levels, which will bring in full reimbursement for the San Ramon, Calif.-based company at participating hospitals. Payers at these hospitals will be required to cover […]
BioVentrix raises $8m
BioVentrix raised $7.9 million in a new offering of convertible notes, according to an SEC filing. BioVentrix produces the Revivent TC transcatheter ventricular enhancement system designed to treat the left ventricle following a myocardial infarction or heart attack. The Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by […]
BioVentrix raises $1.2m
BioVentrix raised $1.2 million in a new round of financing through the sale of convertible notes, according to an SEC filing posted this week. BioVentrix produces the Revivent TC transcatheter ventricular enhancement system designed to treat the left ventricle following a myocardial infarction or heart attack. The Revivent is designed to eliminate the need for cardiopulmonary […]
BioVentrix wins CE Mark approval for Revivent TC heart failure device
Bioventrix said today it won CE Mark approval in the European Union for its Revivent TC transcatheter ventricular enhancement system designed to treat the left ventricle following a myocardial infarction or heart attack. The Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart by enabling the placement of small titanium […]
FDA approves Bioventrix trial for Revivent TC heart failure device
Bioventrix said today it won FDA investigational device exemption approval to initiate a pivotal trial of its Revivent TC transcatheter ventricular enhancement system device designed for reshaping and restoring the left ventricle. Revivent is designed to eliminate the need for cardiopulmonary bypass or incisions in the heart. Instead, the transcatheter procedure enables placement of small […]
BioVentrix touts 1st-in-human procedure for Revivent device
BioVentrix said it successfully implanted its micro-anchor Revivent device into a 64-year-old female patient suffering from heart failure symptoms following a heart attack. The first-in-human test follows a similar successful procedure in a pre-clinical model last December. Researchers used Revivent in what it refers to as LIVE (less-invasive ventricular enhancement) a transcatheter-based procedure designed to […]