Vascular Flow Technologies said today it raised $14.3 million (£10 million) through multiple rounds of financing to support research & development, strategic joint development and out-licensing agreements with industry partners. The funding round consisted of 2 tranches; a $10 million (£7 million) loan note restructuring into Series A ordinary preference shares and a $4.3 million (£3 […]
Vascular
Velano Vascular wins FDA nod for new blood draw device
Velano Vascular said today that it won 510(k) clearance from the FDA for a new iteration of its needle-free blood draw device. San Francisco-based Velano, which raised a $5 million Series A round in February 2015, won its 1st FDA nod for the device last year. The new clearance covers a pair of modifications to the device aimed […]
ACT touts 1st-in-human trial for RF ablation tech
Advanced Cardiac Therapeutics said yesterday the 1st 12 patients have been treated using its open-irrigated radio frequency ablation technology to treat atrial fibrillation. The treatments were performed in Prague by study principal investigator Dr. Vivek Reddy of Mt. Sinai Hospital, the company said. ACT’s RF tech incorporates a generator with a novel temperature-sensing low-flow catheter […]
Contego touts post-market data for Paladin balloon
Contego Medical today released preliminary data from a post-market registry study of its Paladin carotid post-dilation balloon that showed improved patient outcomes in individuals treated with the system, and no adverse events. The device, which come with integrated embolic protection, is designed to provide embolic protection during post-dilation in carotid stent procedures, the Raleigh, N.C.-based […]
Biotronik expands DCB line with CE Mark for Passeo-18 Lux
Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval […]
Mercator MedSystems launches dual-therapy BTK Bullfrog device trial
Mercator MedSystems said yesterday it enrolled the 1st patient in its Limbo-PTA clinical trial aiming to examine the use of the company’s Bullfrog micro-infusion device delivering anti-inflammatory steroids along with angioplasty to treat patients with below the knee critical limb ischemia. The Emeryville, Calif.-based company said that the purpose of adding an anti-inflammatory drug, delivered by […]
AngioDynamics must face Bard patent infringement lawsuit
AngioDynamics (NSDQ:ANGO) must face a patent infringement lawsuit brought by Bard and subsidiary Bard Peripheral Vascular, a federal judge in Delaware ruled this week. Murray Hill, N.J.-based Bard sued AngioDynamics in March 2015, alleging that its Smart Port and other implantable power-injectable port products trespass on a trio of Bard patents, according to court documents. AngioDynamics asked […]
Medtronic wins CE Mark for In.Pact Admiral DCB for end-stage renal disease
Medtronic (NYSE:MDT) said today its In.Pact admiral drug eluting balloon won CE Mark approval in the European Union for arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease. The device is now cleared for preventing restenosis in hemodialysis access sites by opening up the artery and delivering paclitaxel to the vessel wall. […]
Vivasure wins CE Mark for bioabsorbable vascular closure device
Ireland-based Vivasure Medical said today it won CE Mark approval in the European Union for its bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. The closure device is the 1st from the company’s PerQseal platform, and Vivasure claims its the only approved bioabsorbable, sutureless synthetic option to close large arteriotomies that result from percutaneous […]
Update: Penumbra launches POD packing coil
Update: Added comments from Penumbra CEO Adam Elsesser Penumbra (NYSE:PEN) yesterday launched its POD packing coil in the U.S., designed as a complimentary addition to the company’s Ruby and POD embolization devices. The focus on peripheral vascular products has been significant for the Alameda, Calif.-based company, despite only entering the field a little over a year […]
Vascular Dynamics wins CE Mark for MobiusHD hypertension device
Vascular Dynamics said today it won CE Mark approval for its MobiusHD minimally invasive hypertension treatment device. The MobiusHD is a passive implant delivered percutaneously designed to amplify signaling measured by the baroreceptors in the wall of the carotid sinus. The device reduces blood pressure due to the increase in baroreceptor signaling. “Receiving CE Mark approval for […]