InSeal Medical has received CE mark approval for its InClosure VCD; a large bore vascular closure device. According to a press release, the InClosure VCD is a first-in-class, intravascular closure device based on InSeal Medical’s proprietary and patented technology.
Further sub-group analysis of CORAL trial data indicates that retrieval of renal function after renal artery stenting improves survival and decreases cardiovascular and renal events. J Gregory Modrall, University of Texas Southwestern Medical Center, Dallas, USA, who presented the analysis at the Vascular Annual Meeting (9–11 June, National Harbor, USA), suggested that renal artery stenting in conjunction with angiotensin receptor blocker therapy may be beneficial in some patients with chronic kidney disease.
At the Vascular Annual Meeting (9–11 June, National Harbor, USA), data were presented suggesting that complex triple or quadruple fenestrated endovascular aneurysm repair (FEVAR) does not result in higher mortality or morbidity rates than standard double FEVAR in the treatment of complex aortic aneurysms.
Gore has announced US Food and Drug Administration (FDA) approval of the Gore Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design. The Gore Tigris device, which gained CE mark approval in 2011, is a third-generation, self-expanding stent. The device was designed explicitly to improve anatomical conformability with the natural movement of the knee when treating peripheral arterial disease.
Essential Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the US clinical trial of X-Seal, the company’s 6F vascular closure device.
Sanford Vascular Innovations, a division of Sanford Health, has receive US Food and Drug Administration approval to study the Unitary Manifold stent graft system device to treat complex aneurysms occurring in the descending aorta.
Medtronic and VIVA Physicians reported on 27 July 2016 the first patient enrolled in the REALITY Study. The VIVA-sponsored study is assessing outcomes for patients with significantly calcified and symptomatic femoropopliteal peripheral artery disease, following adjunctive use of directional atherectomy and drug-coated balloon (DCB). Krishna Rocha-Singh, chief scientific officer, Prairie Heart Institute of Illinois, and Brian DeRubertis, associate professor of surgery, UCLA Division of Vascular Surgery, are co-principal investigators. The study will include investigative sites both within the USA and in Germany.
The UK National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on the Lutonix drug-coated balloon (DCB) for peripheral arterial disease. Lutonix (Bard) is a paclitaxel-coated percutaneous transluminal angioplasty catheter indicated for treating peripheral arterial disease.
Frans Moll, professor of Vascular Surgery at the University Medical Center Utrecht, Utrecht, The Netherlands, has received an Honorary Fellowship of the Royal College of Surgeons of Thailand (RCST) during the College’s Annual Scientific Congress in Pattaya, Thailand (16–19 July).
The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”.
A new animal study, presented at EuroPCR (17–20 May, Paris), indicates that a novel, fluoropolymer-coated, self-expanding, paclitaxel-eluting peripheral stent (Eluvia, Boston Scientific) is associated with significantly less neointima at 90 days than is a no polymer, paclitaxel-eluting peripheral stent (Zilver PTX, Cook Medical). Eluvia, which is CE marked but an investigational device in the USA, was also associated with more uniform neointimal coverage.
Vasorum has received approval of its premarket approval application from the US Food and Drug Administration (FDA). Celt ACD, which has received CE mark and is sold in Europe, is indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients.
AV Medical has commenced cases in the USA with its Chameleon angioplasty balloon catheter.
The US Food and Drug and Administration (FDA) has granted 510(k) clearance for the UK-based start-up Cydar’s EV surgical guidance software, used in X-ray guided vascular surgery.
Contego Medical has completed enrolment in the Paladin Carotid Post-dilation Balloon System Registry in Europe. The registry involves 5 centres with 100 total patients, and represents the first prospective clinical evaluation of a new class of device that provides Integrated Embolic Protection (IEP) technology for interventional treatment of carotid stenosis.
Cookies Sociales
Son esos botones que permiten compartir el contenido del sitio web en sus redes sociales (Facebook, Twitter y Linkedin, previo tu consentimiento y login) a través de sistemas totalmente gestionados por dichas redes sociales, así como los recursos (pej. videos) y material que se encuentra en nuestra web, y que de igual manera se presta y gestiona completamente por un tercero.
Si no acepta estas cookies, no podrá compartir nuestro contenido a través de los botones, y en su caso, no podrás visualizar el contenido de terceros que hayamos incrustado en el sitio.
No las utilizamos