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.
BTG has announced the successful outcome of the RENEW study, the pivotal US randomised controlled clinical trial comparing the safety and efficacy of the PneumRx endobronchial coil implant with a medical therapy control group in patients with homogeneous and/or heterogeneous severe emphysema. All primary and secondary endpoints of the study were met.
ArtVentive Medical has conducted the first animal study of its next generation of the ArtVentive Endoluminal Occlusion System (EOS Gen II). The EOS is designed for use in the peripheral vasculature and offers immediate and permanent vessel occlusion in arterial and venous settings.
Stentys has announced that the first interventions using its self-expanding drug-eluting stent to treat BTK (below-the-knee) arterial disease have been performed during two live-case sessions broadcasted during the Leipzig Interventional Course (LINC).
Performing angioplasty with new drug-coated balloons to treat femoropopliteal artery disease results in lower rates of late lumen loss and clinically-driven target lesion revascularisation compared with plain angioplasty at both six- and 12-month follow-up, according to new data.
Essential Medical has completed enrolment of its European CE mark clinical study of Manta, the company’s large bore vascular closure device.
Patient enrolment has begun in Bad Krozingen, Germany, for Mercator MedSystem’s LIMBO-PTA clinical trial. This study measures the benefits of adding drug delivery to the catheter-based re-opening of the arteries below the knee in patients suffering from critical limb ischaemia (CLI). The trial combines localised drug delivery using the Mercator MedSystem Bullfrog micro-infusion device and dexamethasone with angioplasty.
In a presentation at the 2015 Vascular Interventional Advances meeting (VIVA; 2–5 November, Las Vegas, USA), Krishna Rocha-Singh, St John’s Hospital, Springfield, USA, gave an insight into the VIVA Superficial Femoral Artery Nitinol Stent Patient Level Meta-analysis, suggesting that patients with higher ankle-brachial index and shorter lesions have the most positive outcomes. He emphasised the importance of “robust and independently adjudicated” data and more standardised endpoints.
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.
NuCryo Vascular has received 510(k) clearance for its reusable cryoplasty inflation device. NuCryo will be selling the current and next generation model via a direct sales team.
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