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
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 […]
Argon picks up trio of vascular devices from Rex Medical
Argon Medical Devices said today it completed its buy of 3 vascular products from Rex Medical. Included in the buy were Rex’s OptionElite retrievable vena cava filter, Cleaner rotational thrombectomy system and UltraStream chronic hemodialysis catheter, the company said. “We are pleased that Argon Medical will continue in their leadership position delivering these established and tested […]
Xeltis snags $3.2m extension for Series B, closes round with $32m
Xeltis said today it brought in an extra $3.2 million (EU €3 million) extension for its Series B financing round, bringing the total up to $32.4 million (€30 million) for its bioabsorbable cardiovascular valve platform. Xeltis’ is designing a platform of bioabsorbable cardiovascular valves and vessels, starting with the pulmonary valve, designed to allow endogenous […]
Avenu Medical pulls in $6m for Ellipsys AV fistula device
Vascular access system maker Avenu Medical raised $6 million in a new round of debt financing, according to an SEC filing. Avenu Medical, founded in 2010, is developing and producing the Ellipsys vascular access image-guided catheter system, designed to percutaneously create arteriovenous fistulas for hemodialysis access. Funds came from 46 anonymous investors, according to an SEC […]
Boston Scientific recalls select Acuity guide catheters
Boston Scientific (NYSE:BSX) is recalling select lots of its 9Fr Acuity Pro coronary sinus outer guide catheters due to issues with the proximal handle separating from the shaft of the device. Boston Scientific named 16 different models in the recall, with 158 different lot numbers indicated. The recalled Acuity catheters are designed to provide pathways into […]
PAD: Boston Scientific wins FDA, CE Mark nods for thrombectomy catheter
Boston Scientific (NYSE:BSX) said yesterday it won both FDA premarket approval and CE Mark approval in the European Union for its AngioJet ZeltanteDVT thrombectomy catheter designed to treat deep vein thrombosis. The ZelanteDVT is the 1st AngioJet catheter from Marlborough, Mass.-based Boston Scientific specifically designed to treat deep vein thrombosis, specifically in large-diameter upper and lower […]
Study: 3D MRI reveals early stroke risk in diabetics
A new study suggests that diabetes patients may be at a higher risk for stroke due to harboring advanced vascular disease, and that arterial imaging with 3D MRI could help determine stroke risk in diabetes patients. Data from the study is slated to be presented at the Radiological Society of North America’s annual meeting next […]
FDA warns on intravascular device coating separation issues
The FDA said today that clinicians using intravascular medical devices such as catheters and guidewires should be aware of issues that can arise when their hydrophilic or hydrophobic lubricious coatings separate. The coatings reduce friction between the device and the blood vessel, but when the coating begins to flake, peel or slough off, the federal watchdog […]
NaviGate performs 1st-in-human transcath mitral valve replacement
Emerging heart valve-focused company NaviGate Cardiac Structures said it performed the 1st-in-human implant of its catheter-guided, mitral-valved stent. The company’s transcatheter mitral valve replacement system includes 2 sets of stent wings designed to surround the valve and incorporate leaflets against the valve annulus, which open with stent self-expansion to attach to the mitral valve annulus […]
Angiodroid yanks 510(k) over FDA CO2 clearance issue
ADM Tronics Unlimited said last Friday Angiodroid Americas withdrew its FDA premarket notification 510(k) application for the Angiodroid CO2 injector for angiography over lack of clearance for CO2 related to the indication. The Angiodroid device is an automatic injector for peripheral angiography that used CO2 gas which the company claims eliminates issues with iodine contrast medium […]