The systematic review of administrative dataset registries, published in the January 2016 issue of the European Journal of Vascular and Endovascular Surgery (EJVES), has further concluded that stroke/death rates after carotid stenting often exceed accepted American Heart Association (AHA) thresholds. Based on this study, there was also no evidence of a sustained decline, over time, in the procedural risk after carotid stenting.
The Paladin carotid post-dilation balloon (Contego Medical) is to be commercialised in Europe. This device, according to a press release, is the first angioplasty balloon with Integrated Embolic Protection (IEP) technology for patients undergoing carotid stenting procedures.
Medtronic is to launch the OsteoCool radiofrequency ablation system for surgeons who treat patients with painful spinal metastases. The system has been granted US Food and Drug Administration (FDA) 510(k) marketing clearance.
The first US implant of the Gore Excluder thoracoabdominal branch endoprosthesis has taken place during a clinical study of the treatment of aortic aneurysms involving the visceral branch vessels.
The IN.PACT Admiral drug-eluting balloon (DEB) has been granted CE mark for arteriovenous (AV) access to help maintain haemodialysis access in patients with end-stage renal disease, according to a Medtronic press release.
Vivasure Medical has been granted CE mark approval for its fully bioabsorbable percutaneous vascular closure device for large-bore femoral arteriotomies. According to Vivasure, this is the world’s first approved bioabsorbable, sutureless and fully synthetic option to close large arteriotomies, which result from percutaneous transcatheter procedures.
Early research on a simple method to produce radiopaque drug-eluting microspheres that can be incorporated into the current clinical transcatheter arterial chemoembolization workflow has also been reported.
Forge Medical has announced receiving 510(k) clearance from the US FDA for expanded indications of the device to include pedal and tibial haemostasis. The VasoStat was previously cleared for radial artery and dialysis access haemostasis.
Penumbra’s POD (Penumbra Occlusion Device) packing coil for the embolization of peripheral vessels and aneurysms adds to its growing peripheral vascular business, which includes the Indigo mechanical thrombectomy system, POD and Ruby embolization coil.
NuCryo Vascular has announced receiving 510(k) clearance on the next generation reusable Cryoplasty inflation device. The company has also announced that it will be selling the current and next generation model via a direct sales team.
The MobiusHD minimally invasive system from Vascular Dynamics has been granted CE mark approval for the treatment of resistant hypertension.
Argon Medical Devices has completed the acquisition of three vascular products from Rex Medical. The OptionELITE retrievable vena cava filter, Cleaner rotational thrombectomy system, and UltraStream chronic haemodialysis catheter are now wholly owned by Argon Medical Devices.
As of mid-December 2015, researchers have activated the first 10 medical sites and enrolled the first nine patients in a large US study that will determine the safety and effectiveness of inferior vena cava filters.
Patients who feel scared, distressed or hostile before undergoing an interventional radiology procedure may experience a poor outcome, according to research presented at the Radiological Society of North American Annual Meeting (RSNA) in Chicago in early December.
Medtronic will manufacture the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD) at a new facility in Galway, Ireland.
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