FDA offers guidance on angioplasty and specialty catheters

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for...Read more on AuntMinnie.comRelated Reading: FDA offers guidance on coated devices Cinematic rendering offers clinical utility in MSK CT Coronary CTA beats stress test for changing lifestyles Medtronic launches new endoscopic catheter r4 Vascular gets FDA clearance for PTA balloon
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news

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Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
Significant narrowing of the branch pulmonary arteries (PA) may occur following surgical arterioplasty which can lead to disproportionate pulmonary blood flow to the lungs. The conventional procedure of percutaneous transluminal balloon angioplasty of narrowed branch PAs is of limited usefulness in reducing the pressure gradients and importantly, it can have fatal implications like vessel rupture, dissection, aneurysm formation or even death.1 The advent of balloon expandable stents has given better results with lower recurrence rates and complications.
Source: Journal of Cardiothoracic and Vascular Anesthesia - Category: Anesthesiology Authors: Source Type: research
Publication date: Available online 5 October 2020Source: Journal of the Formosan Medical AssociationAuthor(s): Zheng-Wei Chen, Cho-Kai Wu, Ping-Hung Kuo, Hsao-Hsun Hsu, Cheng-Hsuan Tsai, Chien-Ting Pan, Juey-Jen Hwang, Chi-Lun Ko, Yu-Sen Huang, Takeshi Ogo, Yen-Hung Lin
Source: Journal of the Formosan Medical Association - Category: General Medicine Source Type: research
This study aimed to clarify the usefulness of the Ikari-curve left (IL) guiding catheter for balloon pulmonary angioplasty (BPA).The current BPA strategy for chronic thromboembolic pulmonary hypertension is dilation of as many branches as possible to normalize hemodynamics and oxygenation. The shape of the guiding catheter is a major factor in achieving this. However, conventional guiding catheters are difficult to introduce into particular branches. The IL guiding catheter may be suitable; however, its utility remains unclear.We retrospectively analyzed 202 consecutive BPA sessions of 40 patients from November 2016 to Oct...
Source: International Heart Journal - Category: Cardiology Tags: Int Heart J Source Type: research
Authors: Golino M, Nuzzo S, Briguori C Abstract Stentys self-apposing stent was designed to face complex lesions in the precincts of percutaneous coronary interventions. Nitinol platform and disconnectable struts were designed to provide a complete apposition on the vessel wall in challenging lesions such as significant tapering, primary angioplasty in ST segment elevation myocardial infarction and bifurcation. Stentys X-Position S is a sirolimus eluting stent with a novel delivery system aiming to improve positioning. Clinical trials showed good results in terms of procedural success rate, clinical outcome and sho...
Source: Minerva Cardioangiologica - Category: Cardiology Tags: Minerva Cardioangiol Source Type: research
Publication date: Available online 28 September 2020Source: Respiratory Medicine Case ReportsAuthor(s): Tomohiro Yamaguchi, Yasuhiro Izumiya, Hiroya Hayashi, Yoshitaka Ichikawa, Hirotoshi Ishikawa, Atsushi Shibata, Takanori Yamazaki, Minoru Yoshiyama
Source: Respiratory Medicine Case Reports - Category: Respiratory Medicine Source Type: research
CONCLUSIONS: Radiographically detectable caval pseudoaneurysm and extravasation is not uncommon in complex inferior vena cava filter retrieval and, despite being considered a major complication by Society of Interventional Radiology guidelines, can often be managed without stenting or other invasive treatment. PMID: 32998667 [PubMed - as supplied by publisher]
Source: Vascular - Category: Surgery Authors: Tags: Vascular Source Type: research
CONCLUSIONS: This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required. PMID: 32990327 [PubMed - in process]
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
AbstractObjectivesWe aimed to compare the short ‐ and midterm results of perfusion strategies used for arch reconstruction surgery.Material and MethodsOne hundred and seventy ‐three consecutive patients who underwent aortic arch reconstruction surgery for transverse arcus hypoplasia between January 2011 and February 2020 were retrospectively analyzed. The patients were divided into two groups, as beating heart (BH) group and cardiac arrest (CA) group.ResultsThe CA group comprised 60 (35%) patients and the remaining 113 (65%) patients were in the BH group. The median age of the patients was 30 (interquartile range: 18 &...
Source: Journal of Cardiac Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
Conclusions: Implantation of the p48MW/p48MW HPC is safe and effective for treatment of distally located cerebral aneurysms. Considering the reported rates of ischemic complications associated with flow diversion of complex bifurcation aneurysms, the p48MW/p48MW HPC potentially provides increased safety for complex bifurcation aneurysms in the anterior and posterior circulation.
Source: Frontiers in Neurology - Category: Neurology Source Type: research
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