Webbdilator, vessel, for percutaneous catheterization. 22. 510 (k) Number. K223472. Device Name. TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) Applicant. Spectranetics Inc. 9965 Federal Drive. WebbLead extraction for CIED infection can be a life-saving procedure. Yet, over 65% of CIED infection patients are treated inappropriately 6.Any patient with a CIED and an infection should be referred quickly for a lead extraction consultation, as data shows delaying lead extraction can lead to mortality. 6-7 Also, >80% of patients with a noninfectious …
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WebbComplete procedural success with TightRail™ system alone was achieved in 22 (95.7%) patients (41/42 leads) and overall clinical success was 100%. One right ventricular lead was completely removed with the help of femoral snare. All the patients were discharged uneventfully without any complication. WebbTightRail Guardian Motorized Dilator Sheath Indications for Use (Describe) Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2024 See PRA Statement below. The TightRail Guardian Motorized Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads. lithium tablets side effects
Comparison between TightRail rotating dilator sheath and …
WebbFunda del dilatador giratorio mecánico. Con TightRail, la flexibilidad se une a un control sin igual. El eje flexible de la herramienta ayuda a los médicos a permanecer coaxiales al electrodo. La exclusiva tecnología del eje mantiene el avance a través de la tortuosa vasculatura. La parte dilatadora permanece protegida hasta que se activa ... WebbSupported development efforts to optimize the TightRail lead extraction device. Built a test fixture that helped the design team characterize … Webb7 dec. 2016 · tightrail guardian motorized dilator sheath, 9 french (575-009); tightrail guardian motorized dilator sheath, 11 french (575-011); tightrail guardian motorized dilator sheath, 13 french (575-013) 21. Spectranetics Inc. K223472. 22. 12/15/2024. tightrail guardian motorized dilator sheath. 23. Spectranetics, Inc. lithium table of elements