Saphenion®: long-time results of vein glue – experience in the therapy of 4531 varicose veins
Saphenion®: We have published long-term results of vein glue in regular succession for 10 years. It aims to compare international publications on the subject with our own experiences and remain meaningful. Our patients are now very well informed about this therapy method for varicose veins, which has been offered for 13 years.
After 148 months of use, we have treated 2172 patients on 4531 saphenous veins – over 1,1 Mio. patients worldwide have now been treated with the vein glue VenaSeal®. In the meantime, we have successfully used the vein glue VenaSeal® to clean the vein system in 66 patients with COVID-19 infection after they recovered.
Of course, slightly adapted hygiene measures in the operating room and practice are necessary. However, these are kept within practical limits in an outpatient specialist practice that works surgically and with catheter medicine, since the hygiene status is already primarily increased.
https://www.ajsccr.org/article-details.php?tit=AJSCCR-v5-1792
https://www.ajsccr.org/uploads/IMG_510052.pdf
Saphenion®: Long-time results of vein glue – News from the German Specialist Association for Vein Medicine
Saphenion: long-time results of vein glue – The German Society for Vein Medicine (DGP) also includes therapy with the vein glue VenaSeal® as a therapy recommendation for the therapy of truncal varicose veins in the current guidelines „S2k -guideline for diagnosis and therapy of varicosis“.
Together with colleagues from Munich, Hildesheim, Cologne, Düsseldorf, Saphenion® Berlin / Rostock discussed and founded a „VenaSeal® – network“ in spring 2020 on the occasion of the „Bonn Vein Days“. We aim to summarize the therapy results with the vein glue, exchange experiences communicate them to our patients, and become scientifically active. In November 2020 our joint „German Multicenter Study VenaSeal®“ was published.
Saphenion: long-time results vein glue – 148 months
Saphenion: long-term results vein glue – 148 months ago, we started using vein glue to treat varicose veins. There are now 4531 teated veins in the surgery book. We have used vein glue in 2172 patients so far. In addition to many well-informed patients who are now directly requesting this therapy method, statutory health insurance companies have also recognized the procedure as no longer so new in some cases.
Most private insurance companies have also accepted the therapy option of vein gluing varicose veins as part of the cost estimates presented. Likewise, according to reports from our patients, the federal aid offices, the states of Berlin / Brandenburg, Mecklenburg, Saxony / Anhalt, Saxony, and Thuringia as well as Lower Saxony and Schleswig-Holstein are ready to cover the costs of this therapy method, which was approved in Europe in 2011. Our patients should speak to their insurance company before arranging a therapy appointment if in doubt.
Saphenion® – our 2000th VenaSeal® – Patient
Saphenion®: Long-time results of vein glue
Saphenion®: long-term results of vein glue—After more than 12 years of practical work with vein glue, we see—like the international studies—its high effectiveness with a very low rate of side effects. Initially approved and used by the manufacturer exclusively for normal-caliber saphenous veins, the glue has conquered other application areas in endovenous therapy. Ecstatic veins and aneurysms are now successfully treated with vein glue.
This becomes clear in the literature analysis. Colleagues from the USA, Korea, Holland, Russia, and Hong Kong have presented 3-5-year studies. In addition to our 10-year long-term study and the German VenaSeal® multicenter study, Morrisson et al. presented a 5-year study, as did Gibbson et al. The results are almost identical in all studies. The closure rate after these long periods is between 94 and 97%.
Our results after 148 months of use are a 96,18% closure rate.
This means that the vein glue is more effective than the established radio wave system – but with significantly fewer side effects and a shorter post-op recovery phase. The ability to work is restored on the same day approximately 3 hours after the therapy – or – if sedation is used, the following day.
Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized cyanoacrylate closure versus radiofrequency ablation trial for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15. PubMed PMID: 29914814.
Tang TY, Yap CJQ, Chan SL, Soon SXY, Yap HY, Lee SQW, Choke ETC, Chong TT. Early results of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):335-345.e2. doi: 10.1016/j.jvsv.2020.03.020. Epub 2020 May 7. PMID: 32387378.
Cho S, Park HS, Lee T, Byun SJ, Yun WS, Yang SS, Kim H, Kim WS, Joh JH, Jung IM. CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study is a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for treating incompetent saphenous veins. Trials. 2020 Jun 3;21(1):460. doi 10.1186/s13063-020-04393-0. PMID: 32493398; PMCID: PMC7268719.
Saphenion®: long-time results of vein glue – therapy extension leg ulcer
The treatment of the so-called „open leg“ (ulcus cruris) has become much more straightforward, more effective, and more effective. The vein glue can also be used in a minimally invasive manner for the most severe findings. So far we have used the venous glue in 67 patients with leg ulcers – with great success!
O’Banion LA, Reynolds KB, Kochubey M, Cutler B, Tefera EA, Dirks R, Kiguchi MM. Treatment of superficial venous reflux in CEAP 6 patients: a comparison of cyanoacrylate glue and radiofrequency ablation techniques. J Vasc Surg Venous Lymphat Disord. 2021 Jan 13:S2213-333X(21)00001-9. doi: 10.1016/j.jvsv.2020.12.082. Epub ahead of print. PMID: 33453440.
Park I. Successful use of VenaSeal system for the treatment of large great saphenous vein of 2.84 cm diameter. Ann Surg Treat Res. 2018 Apr;94(4):219-221. doi: 10.4174/astr.2018.94.4.219. Epub 2018 Mar 26. PubMed PMID: 29629358; PubMed Central PMCID: PMC5880981.
Saphenion: long-time results of vein glue – perforator veins
The human venous system has around 140 pairs of perforated veins, most of which are located on the lower leg. Of these connecting veins, about 18-20 pairs of veins are of clinical importance. That is why they are also called key perforation veins. In over 60% of cases, these veins appear as a pair and accompany skin arteries as they pass through muscle fascia to the skin.
Therapy of perforating varicose veins with vein glue: This technique provides an elegant and safe way to close the perforating veins at the same time as the therapy of the truncal varicose veins using vein glue. On the one hand, perforation veins are already closed during the catheter maneuvre in the truncal vein by dispensing an additional drop of glue at the mouth (ultrasound control!). On the other hand, after sealing the saphenous veins, we also punctured and glued the perforating vein directly under sight in the same session with the puncture needle lying on the operating table.
Kiguchi MM, Reynolds KB, Cutler B, Tefera E, Kochubey M, Dirks R, Abramowitz SD, Woo EY, O’Banion LA. Perforator treatment is needed after VenaSeal and ClosureFast endovenous saphenous vein closure in CEAP 6 patients. J Vasc Surg Venous Lymphat Disord. 2021 Jun 7:S2213-333X(21)00295-X. doi: 10.1016/j.jvsv.2021.04.020. Epub ahead of print. PMID: 34111593.
Saphenion®: long-time results of vein glue – arterial occlusion
Saphenion has also started to treat patients who are suffering from an arterial occlusive disease (smoker’s leg) and at the same time have functionally defective truncal varicose veins using VenaSeal® at the same time – or before the operation on the arteries – initially on the diseased veins. With this, a weighty dogma of vascular surgery – the importance of arterial therapy – could now be repealed!
Saphenion®: long-time results of vein glue – outpatient therapy for seriously ill people
We now treat dementia or debilitating patients, Parkinson’s disease sufferers, and trisomy patients on an outpatient basis with light sedative medication. Systemic infectious diseases such as hepatitis, COVID-19 (66 cases), or HIV are also not a contraindication – patients with these underlying diseases have been successfully treated with the venous glue several times – without side effects.
Multiallergic diseases are also no contraindications for treatment with vein glue. Patients with lifelong thrombosis/embolism therapy can be successfully treated on an outpatient basis without discontinuing or changing the permanently necessary medication.
Saphenion®: Long-time results of vein glue – therapy for adolescents
Saphenion®: 148 months vein glue – In the past, varicose vein therapy was practiced with great caution in children and adolescents. The well-known radical surgical „stripping“ – pulling out the trunk and side branch varicose veins was, in the imagination of the vascular surgeons, really unsuitable for working on the legs of young people – unless there was an acutely life-threatening finding (thrombosis) or a malformation (vascular tumor).
Since 2000 catheter-supported procedures have been introduced into the therapy of truncal varicose veins – microfoam, radio wave, laser, superheated steam, and vein glue. Long-term results are now available – the radio wave and the vein glue have also been proven to be effective in large-caliber veins > 1.5 cm in diameter. There is no more reason to exercise restraint with the young patient. There is no longer a reason to practice a medically senseless wait-and-see attitude with the proven varicose vein because of radical surgical techniques. This no longer heals, not with cream, gel, or tablet, or even with compression stockings!
On the contrary, catheter procedures offer considerable advantages, especially for the young patient group, when considering radical surgical techniques‘ side effects and complications. And fully thought of the end of the therapy options, the cold „non-thermal“ procedures vein glue and microfoam are the best for the therapy of young patients. No anesthesia, no extensive anesthesia – injections and with the VenaSeal® vein glue no more compression stockings. And we achieve immediate mobility for the adolescent patient.
Saphenion®: long-time results of vein glue – pregnancy
Saphenion®: long-time results of vein glue – The classic therapy methods here are compression therapy with custom-made stockings or, better still, tights, manual lymph and tissue massages and alternating showers, cold showers, and lots of exercises – midwives, and obstetricians are very familiar with this.
http://www.babycenter.de/a8586/krampfadern
The situation is different with functionally defective side branches and truncal varicose veins. Incidentally, as is known from reticulare and spider veins, these do not largely regress after delivery and weaning! There is a risk of serious complications, such as phlebitis or even thrombosis, especially during pregnancy (hormones and mechanical stress).
So far, the dogma has been that no active therapy methods are used to treat truncal varicosis during pregnancy!
Phlebitis is treated with compression therapy, administering antithrombotic drugs that do not flow through the placenta into the unborn child, and, if necessary, suctioning the thrombosed blood from the inflamed vein. Under certain circumstances, however, active therapy on the truncal varicose veins may also be essential from a prophylactic point of view. This must not result in anesthesia or large-scale injections of local anesthetics, as these drugs also reach the fetus via the placenta. A small local anesthetic must be enough! Conventional methods, stripping, and phlebectomy are eliminated, and lasers and radio waves are not feasible without general anesthesia or tumescence.
In clinical use for 13 years, we now have a catheter-supported procedure with the necessary criteria for use during pregnancy, vein gluing using VenaSeal® – Closure. Anesthesia is no longer necessary, the glue cannot cross the placenta after extensive tests by the American Health Authority FDA and the pregnant woman is in no way immobilized after the minimally invasive catheter operation.
Under strict consideration of the indications for this procedure – severe pain symptoms in the patient, phlebitis, and threatened thrombosis as well as severe infectious skin changes and ulcerations – this can be carried out after extensive information and the sole will of the patient.
Saphenion®: long-time results of vein glue – side effects and complications
Our own experiences with the allergy in question to the vein glue have recently been presented in an international publication:
A current search in the international specialist literature in preparation for this update has described the occurrence of contact dermatitis (inflammation of the skin after contact with cyanoacrylate) in 5 cases (in > 1,1 Mio patients!) and only one case a – supposed – VenaSeal® – allergy. Further complications during use or in the post-operative course are still not shown. We have not yet seen a VenaSeal® allergy, even after 2172 patients and 4531 veins were treated.
Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2020 Mar;8(2):280-284. doi: 10.1016/j.jvsv.2019.04.014. Epub 2019 Jul 4. PMID: 31281102.
Fiengo L, Gwozdz A, Tincknell L, Harvey V, Watts T, Black S. VenaSeal closure despite an allergic reaction to n-butyl cyanoacrylate. J Vasc Surg Cases Innov Tech. 2020;6(2):269-271. Published 2020 Apr 10th. doi:10.1016/j.jvscit.2020.03.011
Jones AD, Boyle EM, Woltjer R, Jundt JP, Williams AN.J Vasc Surg Cases Innov Tech. 2019 Aug 7;5(3):372-374. doi: 10.1016/j.jvscit.2019.05.004. eCollection 2019 Sep.PMID: 31440717
Navarro-Triviño FJ, Cuenca-Manteca J, Ruiz-Villaverde R. Allergic contact dermatitis with systemic symptoms caused by VenaSeal. Contact Dermatitis. 2020;82(3):185-187. doi:10.1111/cod.13431
Park I. Human Saphenous Vein Histopathology 2 Years After Cyanoacrylate Closure Using the VenaSeal™ System. Ann Vasc Surg. 2021 Feb;71:534.e17-534.e21. doi: 10.1016/j.avsg.2020.09.017. Epub 2020 Sep 16. PMID: 32949737.
Watts TJ, Thursfield D, Haque R. Allergic contact dermatitis caused by VenaSeal tissue adhesive. Contact Dermatitis. 2019;80(6):393-395. doi:10.1111/cod.13206
Our statement on alleged phlebitis after the vein glue – it is a tissue reaction of the surrounding tissue – has also been confirmed many times in further scientific studies:
Gibson K, Minjarez R, Rinehardt E, Ferris B. Frequency and severity of hypersensitivity reactions in patients after VenaSeal™ cyanoacrylate treatment of superficial venous insufficiency. Phlebology. 2020;35(5):337-344. doi:10.1177/0268355519878618
Nasser H, Ivanics T, Shakaroun D, Lin J. Severe phlebitis-like abnormal reaction following great saphenous vein cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul;7(4):578-582. doi: 10.1016/j.jvsv.2019.03.010. Epub 2019 May 8. PubMed PMID: 31078516.
Park I, Jeong MH, Park CJ, Park WI, Park DW, Joh JH. Clinical Features and Management of „Phlebitis-like Abnormal Reaction“ After Cyanoacrylate Closure for the Treatment of Incompetent Saphenous Veins. Ann Vasc Surg. 2019;55:239-245. doi:10.1016/j.avsg.2018.07.040
Park I. Human Saphenous Vein Histopathology 2 Years After Cyanoacrylate Closure Using the VenaSeal™ System. Ann Vasc Surg. 2021 Feb;71:534.e17-534.e21. doi: 10.1016/j.avsg.2020.09.017. Epub 2020 Sep 16. PMID: 32949737.
Tang TY, Tiwari A. The VenaSeal™ Abnormal Red Skin Reaction: Looks Like but is not Phlebitis! Eur J Vasc Endovasc Surg. 2018;55(6):841. doi:10.1016/j.ejvs.2018.02.003
In a large American meta-analysis, all results and experiences on VenaSeal® – therapy published by us and presented in our news were confirmed:
Kolluri R, Chung J, Kim S, Nath N, Bhalla BB, Jain T, Zygmunt J, Davies A. Network meta-analysis to compare VenaSeal with other superficial venous therapies for chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2020 Feb 13. PII: S2213-333X(19)30702-4. doi: 10.1016/j.jvsv.2019.12.061. [Epub ahead of print] Review. PubMed PMID: 32063522.
Saphenion®: Fact check Vein glue for varicose veins – the current article in „phlebology“ 2023
On the other hand, we cannot in any way follow the current article in the international journal „Phlebology„, which is a completely unobjective and unscientific manner establishes a link between the vein glue VenaSeal® and serious complications in patients following treatment with the vein glue (thrombosis of deep veins, pulmonary embolisms, heart attacks, strokes).
The references are also extremely questionable and, finally, the authors‘ absurd assertion in the title of the article is completely relativized in the course of the discussion. We are asking ourselves why this article was written as it was – our many years of positive experience and many satisfied patients are not reflected in any way!
Phlebology,2023, Vol. 0(0) 1-16, 2023, Arucie reuse guidelines: 501:10710235533121
Letter to the editor regarding 899 serious adverse events due to cyanoacrylate adhesive closure for varicose veins.
In her article, Ms Mendoza adopts the original article by Parsi, Whiteley et al. from the journal ‘Phlebology 2023; 39, 80 – 95’. We would like to thank her for selecting this work and presenting it in German for the journal Phlebology. In this way, the article will be more widely disseminated and better recognized.
Unfortunately, there are no critical reviews of the article in German so far, as the first authors also criticized how the FDA evaluation collected information in their discussion. In her publication, Ms Mendoza goes into detail about the – unproven – side effects and calls for further clarification and data collection on complications. This is certainly correct and is organized in the same way by our colleagues in Germany.
We at Saphenion have been using the vein glue since 2012 and have treated 4531 truncal veins to date. We have regularly published our results at lectures and on the website www.saphenion.de, in a readable form for both colleagues and our patients. We keep a detailed database of all side effects and complications that we recognize in our patients, and have done so since our first procedure. And we have a predefined follow-up protocol that naturally also records undesirable side effects. And I can assure you that we have not yet seen or noticed the significant vascular complications mentioned by Parsi / Whiteley in the original paper, nor have our patients reported any. I therefore consider the publication in this form to be unscientific and highly questionable.
I am sure you have already received other letters from doctors on the subject. However, it is very important to me to point out a completely missing and unmentioned connection between therapy and complications in the publication by Parsi, Whiteley, et al. There are reports of serious vascular complications, thromboses and embolisms, heart attacks, and apoplectic insults in connection with the VenaSeal adhesive. But it is completely negated that we had a coronavirus pandemic from 2020 to 2024 with drastic infection rates and harassing vaccination campaigns [1-11]. Both have been proven to have played a significant role in the many vascular complications in different regions, the virus is a vascular wall virus and the vaccines also attack the vascular walls. The consequences of this corona infection (also known as influenza), which has been known since 2003, and the attempted therapies with various vaccines showed a drastic increase in excess mortality and significant vascular complications – this was also a fact of practical work in the practices of vascular surgeons and phlebologists.
These massive side effects have of course been discussed on all existing social media channels in recent years. They also found their way into the FDA database if the word cyanoacrylate adhesive was included. No further differentiation was made and could not have been made, because then the FDA would have had to track every comment. Who should do this?
The nature of the original publication by Parsi and Whiteley is highly unscientific and tendentious and in no way reflects the experience of the vascular surgeons and phlebologists who work with this system. I would also like to remind you that cyanoacrylates have been increasingly used since the early 1960s in almost all specialties, even intracerebrally and intra-abdominally.
Finally, I would also like to express my incomprehension about the fact that in preparation for the publication in the journal ‘PHLEBOLOGIE’ and also in ‘VASOMED’ no contact was made with colleagues who perhaps already have a lot of experience in the implementation of the therapy technique mentioned. Perhaps this would have allowed the statements to be put into perspective and clean, broadly confirmed results to be published and discussed.
In this form, the original article by Parsi / Whiteley from ‘Phlebology’ is a populist declaration against cyanoacrylate glue in medicine, in particular against its use in vascular diseases, which is not supported by data and experience.
And believe me, if I had experienced any of the side effects mentioned in my 12 years of experience, I would have published them immediately, because there are plenty of treatment alternatives.
Yours sincerely, Dr. Ulf Th. Zierau
Saphenion®: long-time results of vein glue – Discussion with Prof. Dr. Thomas Bürger about the results of vein glue
Saphenion®: long-time results of vein glue – 148 months of therapy experience
Based on the 148 months of practical experience with 4531 treated saphenous veins in 2172 patients, we would like to confirm from our clinical and professional point of view for the fact check:
The vein glue is fully biocompatible, and so far, after more than 12 years of use (148 months), we have not seen any allergies. Two works in the literature describe a contact allergy of the skin after touching the glue. Allergies after injection into the varicose veins have only been described in one case worldwide.
The rate of side effects is therefore well below that of comparable thermal endovenous techniques (laser, radio wave) in treating truncal varicose veins.
The bioresorption of the glue takes between 10 and 36 months. The same resorption processes can also be found in humans as in the more than 150 publications on bioresorption in animals. The resorption models in animal experiments all show a biological degradation of the cyanoacrylate glue between 4 and 9 months. The absorption of the vein glue can also be followed macroscopically with regular ultrasound controls.
Furthermore, We now have our histological findings from human veins 10 – 14 months after endovenous cyanoacrylate vein glue. All four cases examined, show a complete breakdown of the glue in the remnants of the vein. And here too, in addition to our results, there is now another publication:
Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2019 Jul 4. PII: S2213-333X(19)30325-7. doi: 10.1016/j.jvsv.2019.04.014. [Epub ahead of print] PubMed PMID: 31281102.
Saphenion®: long-time results of vein glue – therapy on the lower leg veins, risk of recurrence
Thermal therapy (laser, radio wave, superheated steam) on the lower leg has now been put in a critical light internationally and nationally since the number of nerve lesions after thermal therapy cannot be neglected. At the annual meeting of the Bonner Venentage on the 8th. of March 2024 in Bonn, this topic was discussed again openly. As a result, the majority took a critical stance on thermal therapy of the small saphenous vein, the great saphenous vein on the lower leg, and the therapy of perforating veins using laser or radio waves. These reservations now also apply to the treatment of recurrent varicose veins after radical surgical stripping.
Many colleagues now recommend doing without the thermal laser and radio wave methods; alternatively, catheter-supported microfoam therapy or vein glue is possible. Based on our experience and our study on over 2000 patients, we have defined an indication for microfoam or VenaSeal®. We treat truncal varicose veins on the lower leg with a diameter of up to 0.45 cm with microfoam, and truncal veins with a larger diameter are treated with vein glue.
Our alternative recommendation for radio waves for the saphenous veins on the lower leg, as previously stated in our educational discussions, is no longer applicable. We are now treating the lower leg exclusively with non-thermal methods.
This procedure was also anchored in the „Current guidelines for the therapy of varicosis“ of the DGP.
Saphenion®: long-time results of vein glue – varicose vein aneurysm
Also in aneurysmatic varicose veins until a diameter of 2,8 cm VenaSeal® vein glue is effective and safe in therapy.
Saphenion®: long-time results of vein glue – spider veins and reticular veins?
Saphenion®: long-time results of vein glue – The vein glue for varicose veins is not – as can be read here and there and requested – suitable for the therapy of cosmetically disturbing reticular and spider veins. The microfoam, which has been the „gold standard“ since 2010, is available as a combination therapy.
A simultaneous double therapy with microfoam (ethoxysklerol) is possible but carries the risk of phlebitis. Scientific studies on this combination therapy have Gibson et al. submitted. It is essential first to wait for the truncal varicose veins to heal – in many cases, there is a significant decrease in the lateral branch varicosis! This fact is also considered with Saphenion® and we only carry out the necessary microfoam therapies 14-21 days after the VenaSeal® – therapy.
Photo / Video: Claudia, Madleen, Utzius
Papers / Links
Copy of page 11 of the FDA approval for the biocompatibility of the VenaSeal® vein adhesive:
Table 4: Results of Biocompatibility Testing – VenaSeal Adhesive (Polymerized and the Unpolymerized States) Test Method Reference Results Cytotoxicity (Elution Method) ISO 10993-5.
The cumulative results of the VenaSeal adhesive material cytotoxicity testing, in combination with assessments of toxicological risk and in vivo use, support an overall favorable cytotoxicity profile for the VenaSeal adhesive material per its intended use.
ISO MaximizationSensitization Study(Guinea Pigs)ISO 10993-10VenaSeal adhesive does not elicit a sensitization response
ISO Intracutaneous Reactivity – ISO 10993-10: The cumulative results support that the VenaSeal® adhesive material does not cause intracutaneous reactivity (Material Mediated Rabbit Pyrogenicity
ISO 10993-5US Pharmacopeia Section 151: The cumulative results support that the VenaSeal adhesive material is non-pyrogenic.
Acute Systemic Toxicity- ISO 10993-11: The cumulative results support that the VenaSeal adhesive material is not considered to cause acute systemic toxicity
Subacute / Subchronic ToxicityImplantation (13 weeks) – ISO 10993-11 / ISO 10993-6: The cumulative results support that the VenaSeal adhesive material does not result in any specific adverse systemic toxicological findings in the tissues examined Genotoxicity (Bacterial Mutagenicity, invitro Mouse Lymphoma Assay, Mouse Micronucleus Assay)
ISO 10993-3: The cumulative results support that the VenaSeal adhesive material is non-mutagenic Hemo-compatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time, Platelet and Leukocyte Count), ASTM F-756-08
ISO 10993-4: The cumulative results support that the VenaSeal adhesive material is non-hemolytic and not chronic toxicity Implantation (26 Weeks)
ISO 10993-11/ ISO 10993-6: The cumulative results support that VenaSeal – adhesive does not cause any significant adverse systemic or local toxicity in the tissues examined.
Quelle: Summary – Food and Drug Administration / FDA
Almeida JI, Murray SP, Romero ME. Saphenous vein histopathology 5.5 years after cyanoacrylate closure. J Vasc Surg Venous Lymphat Disord. 2020 Mar;8(2):280-284. doi: 10.1016/j.jvsv.2019.04.014. Epub 2019 Jul 4. PubMed PMID: 31281102.
Bahi M, Guazzo L, Taumoepeau L. Real-world short-term VenaSeal ablation outcomes for symptomatic saphenous incompetence. Vascular. 2023 Jun;31(3):521-525. doi: 10.1177/17085381221077511. Epub 2022 Feb 25. PMID: 35209758.
Bozkurt AK, Balkanay OO, Dinc R. Comparative analysis of VenaBlock and VenaSeal Systems for catheter-guided endovenous cyanoacrylate closure in treating chronic venous insufficiency of the lower extremity: effectiveness and feasibility. Int Angiol. 2024 Jun;43(3):331-341. doi: 10.23736/S0392-9590.24.05143-5. Epub 2024 Jul 23. PMID: 39041783.
Chan YC, Law Y, Cheung GC, Ting AC, Cheng SW. Cyanoacrylate glue used to treat great saphenous reflux: Measures of the outcome. Phlebology. 2017 Mar;32(2):99-106. doi: 10.1177/0268355516638200. Epub 2016 Jul 9. PubMed PMID: 27052039.
Chan SSJ, Yap CJQ, Tan SG, Choke ETC, Chong TT, Tang TY. The utility of endovenous cyanoacrylate glue ablation for incompetent saphenous veins in the setting of venous leg ulcers. J Vasc Surg Venous Lymphat Disord. 2020 Mar 20. PII: S2213-333X(20)30100-1. doi: 10.1016/j.jvsv.2020.01.013. [Epub ahead of print] PubMed PMID: 32205130.
Cho S, Park HS, Lee T, Byun SJ, Yun WS, Yang SS, Kim H, Kim WS, Joh JH, Jung IM. CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study is a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for treating incompetent saphenous veins. Trials. 2020 Jun 3;21(1):460. doi: 10.1186/s13063-020-04393-0. PMID: 32493398; PMCID: PMC7268719.#
Dinc R. VenaBlock® and VenaSeal® class III cyanoacrylate products are effective and safe in varicose vein treatment. Phlebology. 2024 May;39(4):284-285. doi: 10.1177/02683555231221319. Epub 2023 Dec 10. Erratum in: Phlebology. 2024 Dec;39(10):723. doi: 10.1177/02683555241264093. PMID: 38073234.
Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small, and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. 2017 Apr;25(2):149-156. doi: 10.1177/1708538116651014. Epub 2016 Jul 9. PubMed PMID: 27206470.
Gibson K, Morrison N, Kolluri R, Vasquez M, Weiss R, Cher D, Madsen M, Jones A. Twenty-four month results from a randomized cyanoacrylate closure versus radiofrequency ablation trial for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2018 Sep;6(5):606-613. doi: 10.1016/j.jvsv.2018.04.009. Epub 2018 Jun 15. PubMed PMID: 29914814.
Jones AD, Boyle EM, Woltjer R, Jundt JP, Williams AN.J Vasc Surg Cases Innov Tech. 2019 Aug 7;5(3):372-374. doi: 10.1016/j.jvscit.2019.05.004. eCollection 2019 Sep.PMID: 31440717
Jones AD, Boyle EM, Woltjer R, Jundt JP, Williams AN. Persistent type IV hypersensitivity after cyanoacrylate closure of the great saphenous vein. J Vasc Surg Cases Innov Tech. 2019 Aug 7;5(3):372-374. doi: 10.1016/j.jvscit.2019.05.004. eCollection 2019 Sep. PubMed PMID: 31440717; PubMed Central PMCID: PMC6699189.
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https://www.saphenion.de/news/konsensus-1-neef-endovenoese-krampfadertherapie/embed/#?secret=kPFV94HWjphttps://vascularnews.com/veclose-venaseal-safe/embed/#?secret=5Wfx465gUI
