BiO2 wins an investigational device exemption from the FDA for a pivotal trial of its Angel catheter and inferior vena cava filter in the prevention of pulmonary embolism.
BiO2 said it won an FDA nod for a pivotal trial of its Angel catheter and vena cava filter in the prevention of pulmonary embolism.
The 182-patient trial is a single-arm safety & efficacy study of the Angel device in patients at high risk for developing pulmonary embolism who can't take standard drug therapies, according to a press release.
Intravascular imaging company Infraredx files for an initial public offering worth $55 million.
Infraredx yesterday registered for an initial public offering with the Securities & Exchange Commission, estimating the flotation's worth at $55 million.
Burlington, Mass.-based Infraredx makes an imaging system that combines intravascular ultrasound and near-infrared spectroscopy to provide images of the interior of coronary blood vessels.
Vascular Solutions says the FDA granted 510(k) clearance for its Gel-Block embolization foam.
A Covidien study has shown that its new VenaSeal system is just as effective in treating chronic leg vein disorders as its ClosureFast ablation catheter.
The U.S. Justice Dept. issues a 9-count indictment charging Vascular Solutions and CEO Howard Root with running an off-label promotion scheme for its Vari-Lase laser varicose vein device.
Manufacturers of inferior vena cava filters and 2 medical societies team up for a large-scale study of the pulmonary embolism preventers, 4 years after an FDA warning about the devices.
The Society of Interventional Radiology, the Society for Vascular Surgery and 7 medical device companies are teaming up for the 1st large-scale study of inferior vena cava filters, 4 years after an FDA warning that the devices might dislodge or fracture.
Abbott Vascular reportedly lays off 100 workers at a plant in Temecula, Calif.
Abbott Vascular (NYSE:ABT) is laying off about 100 workers at a California plant it acquired when it bought a portion of Guidant Corp. in 2006.