Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the US Food and Drug Administration (FDA) has granted a de novoclassification order for its Surfacer Inside-Out access catheter system. The Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. The Surfacer system employs a novel Inside-Out approach.
Gregg W Stone (Icahn School of Medicine, Mount Sinai, New York, USA) addressed the EXCEL controversy today at the Joint Interventional Meeting (JIM 2020; 13–15 February, Milan, Italy), stipulating that although percutaneous coronary intervention (PCI) has early advantages and coronary artery bypass graft (CABG) confers late advantages, in the long term there are no significant major differences in long-term survival, major adverse cardiovascular events (MACE: death, myocardial infarction[MI], or stroke), or quality of life between the two procedures.
The US Food and Drug Administration (FDA) has authorised marketing of software to assist in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance (Caption Health), is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence (AI) to help the user capture images of a patient’s heart that are of acceptable diagnostic quality.
Biotronik has announced CE mark certification for the Orsiro Mission drug-eluting stent (DES) system. According to a company statement, the next generation of the ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents. Orsiro Mission is now available in CE mark countries.
One of the novel applications of the Altura Endograft System is use in the revision of previously placed endovascular grafts or previous abdominal aortic surgery. Jörg Tessarek (Bonifatius Hospital Lingen, Lingen, Germany) has performed a number of such cases, and will be presenting data on his series at the Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany). Here, Tessarek discusses the benefits of Altura in this type of revision surgery, details a notable case, and finally considers how this novel application of Altura might be of interest to the wider vascular community.
What are the main challenges of relining aneurysms that have been treated with other devices or by open repair in the past, and which are now failing?
Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market the Rist Cath Radial Access Long Sheath (Rist Cath) for the introduction of interventional devices into the peripheral, coronary, and neurovascular system.
XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing devices last year.
At the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), Alvimedica held a Lunch Symopsium in which they introduced a new in-stent treatment of superficial femoral artery (SFA) lesions—Nitides—a technology based on the sustained release of Sirolimus by a SX polymer-free platform.
Medtronic has announced that it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations. Set to enrol 50 patients at up to 15 sites in the USA and Europe, the single-arm study is designed to focus on ablating the distal main renal artery and primary branches to lower blood pressure utilising a simplified procedural approach.
According to the findings of a European multicentre retrospective analysis, the use of drug-coated balloons (DCBs) for the treatment of symptomatic central venous stenosis in dialysis patients has been demonstrated as safe. Presented at the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), the investigation adds to a growing evidence-base for DCBs as a potential treatment for patients in dialysis access.
Laminate Medical Technologies has announced the completion of enrolment into the VasQ external support US pivotal study. The study was conducted at 17 sites across the USA and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for haemodialysis. Both brachiocephalic and radiocephalic AVF patients were included in the study. The patients will be followed for two years with the primary endpoint of primary patency analysed at six months.
Merit Medical Systems has announced that both its EmboCube (syringe-loaded embolisation gelatin foam) and Torpedo (uniform, preshaped gelatin foam loaded into a cartridge with optional blunt stylet) devices are now US Food and Drug Administration (FDA)-indicated for the embolisation of blood vessels to occlude blood flow, which helps control bleeding and haemorrhaging in the peripheral vasculature.
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Radiological Approach to Asthma and COPD-The Role of Computed Tomography.
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Thrombolex announces 510(k) clearance of Bashir catheter systems for thromboembolic disorders
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