The US Food and Drug Administration (FDA) has released a draft guidance document entitled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”.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.
Fenestrated and branched endovascular aneurysm repair (FEVAR/BEVAR) using supra-coeliac sealing zones and four-vessel designs is safe can be performed with “excellent” early outcomes according to data from a study presented at the Vascular Annual Meeting (9–11 June, National Harbor, USA).
Initial results from the STABLE II study indicate that a covered stent graft with a bare metal stent is safe and effective in treating acute, complicated type B aortic dissection. The results were presented at the Vascular Annual Meeting (9–11 June, National Harbor, USA) by Joseph Lombardi, Cooper University Hospital, Camden, USA.
Primary safety and efficacy endpoints for the Nellix system (Endologix) investigational device exemption (IDE) trial have been achieved at one year, with “very low morbidity and mortality and high procedural and treatment success,” according to Jeffrey Carpenter, Cooper Medical School of Rowan University, Camden, USA, at the Vascular Annual Meeting (9–11 June, National Harbor, USA).
Essential Medical has received CE mark approval for Manta, the company’s large bore vascular closure device.
Ash Verma, Clearwater, USA, writes how last year, he happened upon a routine case that struck him as both totally unremarkable and absolutely extraordinary. A 69-year-old female patient presented with one week of swelling and pain in her left arm, notable for a history of lung carcinoma that had, five months earlier, prompted placement of a left subclavian chest port. An ultrasound confirmed occlusive deep-vein thrombosis (DVT) in the patient’s left basilic, brachial, axillary and subclavian veins. A venogram detailed that the occlusive thrombus reached the level of the subclavian vein port catheter entry site.
FlowAid Medical Technologies has received CE mark approval for its FA100 SCCD sequential contraction compression device.
BTG has announced that it has obtained CE mark from the Notified Body British Standards Institution (BSI) following completion of the reclassification of DC Bead and DC Bead M1 as class III medical devices.
According to a new study by the Harvey L. Neiman Health Policy Institute, the last 13 years have seen a substantial growth in the ordering of computed tomography angiography (CTA) examinations in the Medicare population, particularly in the emergency department setting.
Penumbra has launched its new ACE 68 reperfusion catheter in the USA. The catheter is part of the Penumbra System, and was launched at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting in Boston, USA.
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