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FDA issues updated safety communication on use of Endologix AFX endovascular grafts
The Food and Drug Administration (FDA) has issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from a November 2021 meeting of the FDA’s Circulatory System Devices Panel of…
FDA approves two pediatric venous thromboembolism indications for rivaroxaban
The Food and Drug Administration (FDA) has approved two pediatric indications for Xarelto (rivaroxaban): the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of…
Envveno Medical reports successful completion of first VenoValve surgery in US pivotal trial
Envveno Medical—formerly Hancock Jaffe Laboratories—recently announced that the first VenoValve surgery in the company’s SAVVE US pivotal trial for the VenoValve has been successfully completed. The surgery was performed by Adriana Laser, MD, associate professor of surgery at Albany Medical…
Sanford invents Breakthrough Device for TAAA
An investigational device invented at Sanford Health in Sioux Falls, South Dakota, that helps high-risk vascular disease patients has been granted a Breakthrough Device designation by the Food and Drug Administration (FDA). Patrick Kelly, MD, a Sanford Health vascular surgeon,…
Terumo Aortic announces first commercial implants of RelayPro in US
Terumo Aortic today announced the first commercial implants in the U.S. of its RelayPro thoracic stent-graft system. This follows the recent approval by the Food and Drug Administration (FDA) of a device designed to treat patients with fusiform and saccular…
‘Tremendous advances in imaging possibilities’ signal further innovation, says leading vascular chief
It was a complex repair in the thoracoabdominal region of the aorta around 10 years ago, and Matthew Eagleton, MD, and his surgical team were in the process of cannulating several target vessels. They were being guided by what, for…
FDA approves expanded PAD indication for rivaroxaban plus aspirin
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily) to…
PRISTINE registry with Selution SLR sirolimus drug-eluting balloon completes enrollment
MedAlliance has announced completion of patient enrollment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee (BTK) disease. According to a MedAlliance press release, Selution SLR is the first DEB to be…
RelayPro thoracic stent graft approved by FDA
Terumo Aortic today (Friday, Aug. 6) announced that the Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent-graft system for sale in the United States for the treatment of patients with thoracic aortic aneurysms (TAAs) and…
VenoValve granted FDA Breakthrough Device designation
Hancock Jaffe Laboratories today (Wednesday, Aug. 4) announced that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to the company’s VenoValve device, a potential treatment option for chronic venous insufficiency (CVI). “We are very pleased to…