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Peripheral

AngioDynamics puts up $66m for Eximo Medical, cuts outlook

October 3, 2019 By Brad Perriello

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 […]

Filed Under: Featured, MassDevice Earnings Roundup, Mergers & Acquisitions, Vascular, Wall Street Beat Tagged With: AngioDynamics, Eximo Medical, Peripheral

LimFlow wins FDA nod for pDVA trial in chronic limb-threatening ischemia

September 19, 2019 By Brad Perriello

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 […]

Filed Under: Catheters, Clinical Trials, Featured, Vascular Tagged With: LimFlow, Peripheral

Biotronik taps Proximo Medical for U.S. peripheral debut

September 17, 2019 By Sean Whooley

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 […]

Filed Under: Vascular Tagged With: Biotronik, Peripheral, Proximo Medical

Cardinal Health’s Cordis expands recall of some Powerflex Pro catheters

August 28, 2019 By Brad Perriello

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 […]

Filed Under: Catheters, Featured, Recalls Tagged With: Cardinal Health, Cordis Corp., Peripheral

Avinger prices $5m offering

August 22, 2019 By Brad Perriello

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 […]

Filed Under: Featured, Funding Roundup, Wall Street Beat Tagged With: Avinger, Peripheral

InterVene raises $15m Series B for BlueLeaf venous valve repair device

June 25, 2019 By Brad Perriello

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 […]

Filed Under: Catheters, Featured, Funding Roundup, Vascular Tagged With: InterVene, Peripheral

FDA OKs trial for Micro Medical’s below-the-knee stent

June 25, 2019 By Brad Perriello

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 […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: Micro Medical Solutions, Peripheral

Avinger pulls the trigger on 1-10 reverse split

June 24, 2019 By Brad Perriello

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 […]

Filed Under: Wall Street Beat Tagged With: Avinger, Peripheral

FDA panel wants more, better data on paclitaxel-eluting devices

June 21, 2019 By Brad Perriello

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 […]

Filed Under: Catheters, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: becton dickinson, Boston Scientific, Cook Medical, Medtronic, Peripheral, Philips

FDA panel finds ‘smoking gun, but no bullet or dead bodies’ in paclitaxel devices

June 20, 2019 By Brad Perriello

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 […]

Filed Under: Drug-Device Combinations, Drug-Eluting Stents, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: becton dickinson, Boston Scientific, Medtronic, Peripheral

Ra Medical launches large registry trial for peripheral laser device

June 19, 2019 By Brad Perriello

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 […]

Filed Under: Clinical Trials, Vascular Tagged With: Peripheral, Ra Medical

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