Medtronic received medtronic received an abstract titled 'the experience of cac using venaseal'.From january 2020 to december 2021, cacs using venaseal was performed 227 times for 220 tubs of 189 patients (72 males and 117 females) with an average age of 68.0, gsv192, ssv34, giacomini vein 1.The diameter was 6.8 mm (gsv6.9, ssv6.4).And c2 was the most with 173 limbs, c4 was 39.C3 was three, and one limb each for c1 and c5.The length of the treated vein was 28.9 cm for gsv, 10.3 cm for ssv, and 37 cm for giacomini's vein.The stump length was gsv 17.8 mm.Ssv 13.7 mm, and giacomini vein 28.9 mm.A follow-up schedule was one week, one month.And three months after cac using duplex ultrasonography, physical findings, and subjective symptoms.There were non-continuous sites of polymerized cyanoacrylate in some target veins, but blood flow was eliminated in all cases.Postoperative complications were 25 of phlebitis, 2 of page, and 2 of egit, but there were no severe complications.Phlebitis with redness, edema, induration pain, and itching of the skin covering the treated veins occurred in 25 of the 227.In all cases, the anatomical features of phlebitis developed in gsv running shallower than the saphenous compartment.Treatment with corticosteroids, antiallergic agents, and nsalds alone or in combination was needed in 16 limbs.No severe complications reported.
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Abstract titled 'the experience of cac using venaseal'.2022 vol 33 no.2 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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