![]() ![]() The devices are designed, intended, and distributed for single use only. There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, as compared to balloon aortic valvuloplasty or other standard treatments in high or greater risk patients. Warnings: Observation of the pacing lead throughout the procedure is essential to avoid the potential risk of pacing lead perforation. The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring who are judged by a Heart Team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).Ĭontraindications: The valves and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections, or who have significant annuloplasty ring dehiscence. Indications: The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. AngioSculpt can be used in treating fibro-calcific, bifurcation and ostial lesions.Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System The AngioSculpt Scoring Balloon Catheter is a new tool in the treatment of simple to complex lesions, including in-stent restenosis (ISR) and type C lesions. ![]() Originally developed by AngioScore,ĪngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter Ts AngioSculptX Drug-coated PTCA (percutaneous transluminal coronary angioplasty) Scoring Balloon Catheter. We describe the entrapment of an AngioSculpt PTCA balloon catheter during the predilatation of a heavily calcified lesion, analyzing the possible causal mechanism. He AngioSculpt PTCA balloon catheter (Angioscore, Inc.) consists of a semirigid balloon surrounded by nitinol spirals, the purpose of which is to dilate and rupture complex atherosclerotic plaques, minimizing slippage of the balloon, as in cases of restenotic, ostial, fibrocalcific, or other types of lesions. The AngioSculpt RX PTCA scoring balloon catheter is the only specialty scoring device indicated for ISR and complex type-C lesions. ![]() COOK AMPLATZ ULTRA STIFF GUIDE WIRE (145CM / J TIP)ĪngioSculpt RX PTCA scoring balloon catheter significantly alters the landscape for treating CAD, offering the advanced performance that only an innovative clinical solution can provide.Cougar Xt Hydro Track Guidewire Medtronic.Asahi Caravel Microcatheter 135cm/150cm.GRAFT INTERGARD WOVEN STRAIGHT(IGW0022-30).ANGIOSCULPT PTCA SCORING BALLOON CATHETER. ![]()
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