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 […]
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 […]
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 […]
Zoll acquires TherOx
Zoll Medical said today that it acquired TherOx and its acute myocardial infarction treatment. TherOx’s SuperSaturated Oxygen Therapy system delivers a 60-minute infusion of the patient’s super-oxygenated blood to a targeted ischemic area of the heart via a small catheter. The treatment is designed to improve microvascular flow and reduce infarct size following primary coronary […]
Mercator MedSystems raises $14m
Mercator MedSystems said last week that it raised $14.3 million from 25 investors as part of a $15 million equity round. The California-based company is developing catheter-guided micro-infusion systems for non-systemic delivery of therapeutic agents across blood vessels as a treatment for peripheral artery disease. Get the full story at our sister site, Drug Delivery Business […]
Silk Road Medical touts results of carotid artery treatment study
A new study shows that transcarotid artery revascularization (TCAR) procedures significantly lowered the odds of composite in-hospital stroke, death and heart attack compared to surgical removal of plaque from the carotid artery, according to Silk Road Medical (NSDQ:SILK). The company is developing a neuroprotection and stent system called Enroute as an aid to TCAR procedures. […]
Bluegrass Vascular’s pivotal Surfacer trial meets primary endpoints
Bluegrass Vascular Technologies today released preliminary results from the pivotal trial of its Surface Inside-Out access catheter system, touting that the trial met both its primary and secondary endpoints. The San Antonio-based company also said that it has completed enrollment in the SAVE-US trial, recruiting 30 patients across seven U.S.-based centers. “I’m quite encouraged by […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Terumo recalls select Solopath balloon systems
Terumo (OTC:TRUMY;TYO:4543) is recalling a select number of its Solopath balloon expandable transferal system and re-collapsible balloon access systems due to issues with tip dislodgment from the sheath that could cause possible patient injuries. The FDA has labeled the recall as Class I, its most severe classification which is used when there is a reasonable probability […]
Argon Medical Devices buys its U.K. distributor
Argon Medical Devices (Frisco, Texas), an OEM manufacturer of specialty medical products, custom components and drainage catheters, announced that it has completed the acquisition of Mana-Tech, Ltd., its exclusive distributor for the United Kingdom and Ireland. Mana-Tech (Burton-on-Trent, England) is a distributor of biopsy products and radiology consumables in the U.K. The entire Mana-Tech team, including its […]
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