AngioDynamics (NSDQ:ANGO) said today that put up $66 million for Eximo Medical and its B-Laser peripheral atherectomy device and cut its fiscal 2020 earnings outlook to allow for the cost of launching the Eximo product. Latham, N.Y-based AngioDynamics said the deal for Eximo involved $46 million in up-front cash and another $20 million in technical and […]
LimFlow wins FDA nod for pDVA trial in chronic limb-threatening ischemia
LimFlow said today that it won an investigational device exemption from the FDA for a pivotal trial of its catheter-based intervention for a severe form of peripheral artery disease. LimFlow’s percutaneous deep vein arterialization device is designed to re-route blood flow from a blocked artery through the venous system to deliver oxygenated blood to the […]
Biotronik taps Proximo Medical for U.S. peripheral debut
Biotronik tapped Proximo Medical to guide the U.S. commercialization of its peripheral vascular intervention platform. The German medtech maker’s PVI line includes the Pulsar and Astron stents, the Passeo PTA balloon catheter and Fortress introducer sheath. Castle Pines, Colo.-based Proximo provides market research services to medical device, venture capital and private equity companies. “By partnering […]
Cardinal Health’s Cordis expands recall of some Powerflex Pro catheters
Cardinal Health (NYSE:CAH) subsidiary Cordis this week expanded the recall of some of its Powerflex Pro catheters for treating peripheral artery disease, adding three lots to the list. Santa Clara, Calif.-based Cordis first recalled five lots of the Powerflex Pro device in Sept. 6, 2018, after a supplier said they didn’t meet an internal specification for […]
Avinger prices $5m offering
Avinger (NSDQ:AVGR) yesterday priced a stock offering worth nearly $5 million for its line of devices to treat peripheral artery disease. The $4.5 million offering, of more than 3.8 million shares at $1.18 apiece, also includes a 45-day underwriters option on another 572,000 shares that would add $675,000 if exercised in full. The float is slated […]
InterVene raises $15m Series B for BlueLeaf venous valve repair device
InterVene said today that it raised a $15 million Series B round for the venous valve repair device it’s developing. South San Francisco-based InterVene touts BlueLeaf as the first catheter-based treatment for deep vein reflux that doesn’t use an implant. It’s designed to form new venous valves using vein wall tissue, the company said. The […]
FDA OKs trial for Micro Medical’s below-the-knee stent
Micro Medical Solutions said yesterday that it won a nod from the FDA to run a clinical trial of its MicroStent below-the-knee device for treating peripheral artery disease. The Wilmington, Mass.-based company’s MicroStent won CE Mark approval in the European Union in February 2017. A small feasibility study completed last fall met all primary endpoints […]
Avinger pulls the trigger on 1-10 reverse split
Avinger (NSDQ:AVGR) last week pulled the trigger on a one-for-10 reverse stock split to boost its share price above the Nasdaq exchange’s $1-per-share minimum. The split took the number of outstanding shares from roughly 64.2 million to about 6.4 million, Redwood City, Calif.-based Avinger said. AVGR shares, which closed at 41.8¢ apiece June 21, jumped to […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices
Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
Ra Medical launches large registry trial for peripheral laser device
Ra Medical (NYSE:RMED) said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected arteries. It’s designed to minimize damage to the surrounding vessel tissue. The 2,500-patient Results […]
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