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Vascular

BiO2 Medical wins FDA nod for pivotal trial of Angel IVC catheter

January 16, 2015 by Brad Perriello

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.

Infraredx files for $55m IPO

December 23, 2014 by Brad Perriello

Intravascular imaging company Infraredx files for an initial public offering worth $55 million.

Infraredx files for $55m IPO

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.

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Vascular Solutions wins FDA nod for Gel-Block embolization foam

November 25, 2014 by Mark Hollmer

Vascular Solutions says the FDA granted 510(k) clearance for its Gel-Block embolization foam.

Vascular Solutions wins FDA nod for embolization foam

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Covidien study: VenaSeal effective in treating leg veins

November 17, 2014 by Val Kennedy

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.

Covidien study: VenaSeal effective in treating leg veins

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Feds indict Vascular Solutions, CEO over Vari-Lase

November 14, 2014 by Brad Perriello

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.

Feds indict Vascular Solutions, CEO over Vari-Lase

Manufacturers, medical societies team up for IVC filter study

November 13, 2014 by Brad Perriello

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.

Manufacturers, medical societies team up for IVC filter study

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.

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Abbott Vascular lays off 100 in California

November 13, 2014 by Brad Perriello

Abbott Vascular reportedly lays off 100 workers at a plant in Temecula, Calif.

Abbott Vascular lays off 100 in California

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.