Contego Medical launches Neuroguard IEP trial

Contego Medical said today it launched the Performance I trial of its Neuroguard IEP 3-in-1 carotid stent and post-dilation balloon system with integrated embolic protection designed to treat carotid artery stenosis. The first patient in the trial has already been enrolled and treated at Skopje, Macedonia’s University Clinic of Cardiology by Dr. Saško Kedev, the Raleigh, N.C.-based company said. “We are pleased to initiate this trial evaluating the Neuroguard IEP System, the first of its kind for carotid stenting. Protection from stroke is key during carotid artery interventions. This 3-in-1 system includes a novel state-of-the-art carotid stent and provides uninterrupted micro-embolic protection during the most vulnerable stages of the procedure. I am very impressed with the performance of all aspects of the device,” Dr. Kedev said in a prepared statement. In the trial, researchers aim to explore the safety and feasibility of the Neuroguard IEP system, which Contego said contains a novel, next-generation nitinol stent, pre-positioned post-dilation balloon and integrated microembolic filter. “The Neuroguard IEP System signals a new era in carotid artery stenting. By combining a novel stent, post-dilation balloon, and embolic filter onto the same catheter, we expect to dramatically impact this procedure by improving ease of use, reducing interventional time, and maximizing embolic protection. The Neuroguard IEP System represents Contego’s t...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Vascular Contego Medical Source Type: news

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Conclusion: Although the incidence of CI showed a declining trend over a 9-year period, the number and proportion of patients treated for CI increased. Meanwhile, the incidence of CASTN and the number of patients treated for CASTN have demonstrated increasing trends since 2008. On the other hand, the number of patients diagnosed with pediatric MMD decreased, despite no significant change in the incidence. In contrast, the number of patients and the incidence of adult MMD increased. These trends reflect changes in the population structure, gains in the accessibility of imaging examinations, and the development of endovascul...
Source: Journal of Korean Neurosurgical Society - Category: Neurosurgery Tags: J Korean Neurosurg Soc Source Type: research
Jang-Hyun Baek1 and Byung Moon Kim2* 1Department of Neurology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea 2Department of Radiology, Interventional Neuroradiology, Severance Stroke Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea Identification of intracranial, atherosclerosis-related, large vessel occlusion (ICAS-LVO) is important to set up an optimal endovascular treatment strategy, as most ICAS-LVOs require specific endovascular modalities for efficient recanalization. However, there is currently no decisive way to identify ICAS...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Contego Medical, out of Raleigh, North Carolina, won FDA clearance for its Paladin carotid PTA (Percutaneous Transluminal Angioplasty) balloon catheter. The device, used to open up narrow arteries and to post-dilation of self-expanding stents, has a ...
Source: Medgadget - Category: Medical Devices Authors: Tags: Neurology Neurosurgery Radiology Vascular Surgery Source Type: blogs
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection. Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January. A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said. “We are thrilled to have achieved this milestone for the first of several device...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news
This report describes the innovative management of a severe haemodynamic stroke related to an occlusive extracranial internal carotid artery dissection. Intravenous thrombolysis combined with endovascular treatment were undertaken on the basis of a total mismatch profile (National Institutes of Health stroke scale (NIHSS) score of 27 and infarct volume on diffusion-weighted imaging of 0 mL). Balloon angioplasty using a long and compliant balloon microcatheter allowed complete recovery of the intracranial blood flow. The patient showed dramatic clinical improvement (day 1, NIHSS 5) and favourable functional outcome (...
Source: Interventional Neuroradiology - Category: Radiology Tags: Interv Neuroradiol Source Type: research
Conclusion We presented a case of ICA dissection and demonstrated a novel technique for a safe lesion-cross for occlusive ICA dissection. PMID: 29788812 [PubMed - as supplied by publisher]
Source: Interventional Neuroradiology - Category: Radiology Tags: Interv Neuroradiol Source Type: research
ConclusionDEB intervention seems to be an effective and safe treatment for patients with high-grade in-stent restenosis after SPAC.
Source: Neuroradiology - Category: Radiology Source Type: research
Conclusion Matricidal aneurysms require careful consideration and planning. The restricted anatomy of the cavernous sinus can make successful execution of endovascular interventions difficult. Direct elastic compression of the parent artery does not respond to angioplasty and stenting the way that atherosclerotic stenosis does. Because of this, planning for possible parent vessel sacrifice is important. Abstract E-027 Table 1 Intended Treatments and Outcomes n Intended Treatment Failed Treatment (rate) All Patients 37 10 (27%) Flow Diversion 18 5 (28%) Parent Vessel Sacrifice 11 With Bypass 4 2 (50%) Without Bypass 7 0 ...
Source: Journal of NeuroInterventional Surgery - Category: Neurosurgery Authors: Tags: Electronic Poster Abstracts Source Type: research
The SAMMPRIS Trial showed that medical treatment of intracranial stenosis is safer than intracranial angioplasty and stenting (IAS). One of the reasons for the worse outcome with IAS was the occurrence of ipsilateral cerebral hemorrhage, which may be associated with an intracranial exchange maneuver. Newly developed mini intracranial stents may enhance the safety of IAS by obviating the need for this maneuver. We retrospectively evaluated 7 intracranial stenoses (6 patients, 5 men, mean age 57) which were treated with an Atlas stent. In 5 cases there was a high-grade atherosclerotic stenosis which did not optimally respond...
Source: Journal of NeuroInterventional Surgery - Category: Neurosurgery Authors: Tags: Electronic Poster Abstracts Source Type: research
A 56-year-old man presented with vertigo of 4 days duration. Neurologic examination was unremarkable. CT angiograms revealed a right internal carotid artery (ICA) stenosis and an ipsilateral proatlantal intersegmental artery (PIA, type 1). The PIA arose from the ICA, ran upward, then took a dorsal course, and continued as the vertebral artery, serving as the major contributor of the posterior circulation (figure, A–C). Catheter-based angiogram showed ICA stenosis of 60% (figure, D). He chose drug therapy and remained asymptomatic on follow-up. Such combination can lead to TIA of the vertebrobasilar system; treatment ...
Source: Neurology - Category: Neurology Authors: Tags: CT, All Clinical Neurology, All Cerebrovascular disease/Stroke NEUROIMAGES Source Type: research
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