Biotronik said yesterday that it began enrolling patients in a trial designed to assess the safety and efficacy of a new coronary drug-eluting stent in de novo coronary artery lesions. The Biovitesse polymer-free device combines ultra-thin struts with a new anti-proliferative limus drug designed to stop excessive cell growth, the company reported. Get the full story […]
Vascular
India pulls an about-face on Abbott’s Xience Alpine stent
India’s Department of Pharmaceuticals has stopped Abbott (NYSE:ABT) from pulling its Xience Alpine drug-eluting coronary stent from the market. The move is a reversal from the National Pharmaceutical Pricing Authority’s decision last month to allow Abbott to withdraw the device over a one-year period. Get the full story at our sister site, Drug Delivery Business News.
Humacyte lands $14m to expand uses for human acellular vessel
Humacyte said today that it landed a $14.1 million award from the California Institute for Regenerative Medicine to support a clinical trial comparing its human acellular vessel, Humacyl, to arteriovenous fistulas – the traditional way to create vascular access in patients who need hemodialysis. The Research Triangle Park, N.C.-based company said it plans to evaluate […]
Avinger wins CE Mark for in-stent restenosis indication for image-guided atherectomy
Avinger (NSDQ:AVGR) said today that it won CE Mark approval for treating in-stent restenosis with its Pantheris Lumivascular atherectomy system. The company’s Lumivascular tech enables physicians to see from inside the artery during a directional atherectomy procedure in real-time, Avinger touted, using optical coherence tomography. The device is designed to help physicians more accurately navigate their […]
TVA Medical wins CE Mark for EverlinQ 4 endoAVF
TVA Medical said today it won CE Mark approval in the European Union for its EverlinQ 4 endoAVF system designed for creating hemodialysis access using an endovascular approach. The Austin, Texas-based company said the system consists of 2 magnetic catheters which are inserted into an artery and vein in the arm and use a small […]
CardioFocus lands CE Mark for next-gen atrial fibrillation balloon
CardioFocus said today that it won CE Mark approval for its HeartLight Excalibur balloon, designed for the treatment of atrial fibrillation. The Marlborough, Mass.-based company’s device combines the HeartLight endoscopic ablation system with features that optimize the speed and magnitude of target tissue contact during pulmonary vein isolation procedures, according to CardioFocus. The Excalibur balloon […]
LivaNova nabs 510(k) clearance for Optiflow Arterial cannulae
LivaNova (NSDQ:LIVN) said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae. The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles. Optiflow Arterial cannulae have a “basket tip with […]
7 medtech stories we missed this week: Sept. 22, 2017
From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, […]
Endologix wins refined CE Mark indications for Nellix stent graft
Endologix (NSDQ:ELGX) said today it won expanded CE Mark approval in the European Union for its Nellix endovascular aneurysm sealing system with refined indications for use. The Irvine, Calif.-based company said that the refined indications for use were supported by clinical data and an independent clinical reviewer, and that the device met applicable safety and clinical […]
Shockwave Medical touts Disrupt BTK lithoplasty system study results
Shockwave Medical today released results from the Disrupt below the knee study of its Shockwave Lithoplasty system designed to treat peripheral artery disease, touting low rates of residual stenosis and low vascular complications. Data from the study was presented at the annual Cardiovascular and Interventional Radiological Society of Europe congress in Copenhagen, Denmark. “Interventional procedures that […]
Medtronic launches Concerto 3D detachable coil embolization system
Medtronic (NYSE:MDT) said today it launched the Concerto 3D detachable coil system designed for use in the peripheral vasculature. The Fridley, Minn.-based company announced the launch at the Cardiovascular and Interventional Radiological Society of Europe’s meeting in Copenhagen, Denmark. The 3D coil operates as an adjunctive product to the company’s existing Concerto Helix line with indications […]