The safety and efficacy of an extravascular, water‐soluble sealant for vascular closure: Initial clinical results for Mynx™

Scheinert, Dierk; Sievert, Horst; Turco, Mark; Schmidt, Andrej; Hauptmann, Karl Eugen; Mueller, Ralf; Dadourian, D.; Krankenberg, Hans; Grube, Eberhard

doi:10.1002/ccd.21353

Cited by 51 publications

(35 citation statements)

References 57 publications

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“…The Mynx water-soluble sealant system was studied in a multicenter single-arm study of 190 consecutive patients undergoing diagnostic and interventional procedures (5F to 7F). 44 The device was found to have a major complication rate of 0.5% in this low-to intermediate-risk population. A randomized study using the procoagulant pads Chito-Seal (Abbott Vascular Devices) and the Clo-Sur (Medtronic Vascular, Santa Rosa, Calif) compared with manual compression for patients undergoing PCI found only a slightly reduced time to hemostasis with procoagulant pad use without an effect on overall bed-rest time or vascular complications.…”

Section: Evidence For Passive-closure Devicesmentioning

confidence: 78%

Arteriotomy Closure Devices for Cardiovascular Procedures

Patel¹,

Jneid²,

Derdeyn³

et al. 2010

Circulation

137

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Section: Evidence For Passive-closure Devicesmentioning

confidence: 78%

Arteriotomy Closure Devices for Cardiovascular Procedures

Patel¹,

Jneid²,

Derdeyn³

et al. 2010

Circulation

137

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“…Published results with Mynx™ have varied; some report that it is safe and effective [11][12][13] , while others reported significant complication rates with the first generation device 14,15 . In our study, one minor complication was reported (1.8%) which is at the lower range of reported results using manual compression (1.5% to 9 %, 16,17 ), slightly higher than those of angioSeal™ (0.13 to 1.4) 18 , and almost equal to Starclose (1.9%) 19 .…”

Section: Resultsmentioning

confidence: 99%

Safety and Feasibility of a Novel Vascular Closure Device in Neurointerventional Procedures

et al. 2013

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This retrospective study evaluated the safety and feasibility of a new arterial femoral access closure device in neurointerventional procedures. The study includes all consecutive adult patients who underwent femoral arteriotomy closure with the MynxGrip™ closure device after Neurointerventional procedures performed between June and December 2012. All patients had a follow-up color Doppler ultrasound (US) within 48 hours after the procedure, which was independently interpreted by two experienced radiologists to evaluate for access site complications. Device success/failure, sheath size, ambulation time, and periprocedural complications were recorded. Fifty-five closure devices were deployed in 53 patients. There were 23 (43%) males and 30 (57%) females; age ranged from 22 to 84 years (mean: 52.1 years). Thirty of the 55 procedures (55%) were therapeutic and 25 were diagnostic interventions (45%). Sheath sizes used were 5F in 35 procedures (64%) and 6F in 20 procedures (36%). The right femoral artery was accessed in 51 procedures (93%) and the left in four procedures (7%). There was only one (1.8%) minor periprocedural complication (small hematoma). Hemostasis was successful in 51 of the 55 procedures (93%) with subsequent early ambulation. No device-induced complications associated with serious clinical sequelae were reported. In our small series, the MynxGrip™ femoral access closure device provided a safe and feasible way of closing the femoral artery puncture site after neurointerventional procedures with low minor complication rates and no major complications. Further large prospective randomized trials are necessary to evaluate the efficacy of the device.

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“…This combination of safeguards has been reported to make it "virtually impossible to push [the sealant] forward into the artery." 1 The main publication reporting the results of the use of the current-generation Mynx vascular closure device is a prospective nonrandomized trial based in Europe. 1 In this study of 190 patients, rapid hemostasis was achieved (mean, 1.3 minutes) with a success rate of 93%.…”

Section: Discussionmentioning

confidence: 99%

“…This experience led us to try the Mynx vascular closure device, which was reported to be safe and effective and to result in very little pain at the time of deployment. 1 To our knowledge, angiographic or sonographic evaluation of the femoral artery following deployment of the Mynx closure device has not been reported. In this article, we describe the results of follow-up femoral arteriography in the subset of patients in whom the femoral artery was visualized after initial closure with the Mynx device.…”

mentioning

confidence: 93%