angiosculpt balloon sizes

. 17. Bumper Tip 2. OR BROWSE ALL. Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt) . 1, pp. Therefore, the use of scoring balloon angioplasty might be more suitable in the presence of significant vascular calcification. Short (10 mm) ostial right coronary artery CTO that was crossed with a Fielder FC guidwire advanced through a Caravel microcatheter (Asahi Intecc, Nagoya, Japan). Balloon length: 100 mm . The current report focuses primarily on femoropopliteal lesions of significant length (mean length in the Angiosculpt group 11.3 5.9 cm, in the non-Angiosculpt group 10.9 5.3 cm, ns). Precision Power Safety June 24, 2015Spectranetics Corporation announced that it has received US Food and Drug Administration 510 (k) clearance for its AngioSculpt percutaneous transluminal angioplasty scoring balloon catheter in 7- and 8-mm-diameter balloon sizes, which are suitable for treating narrowing native or synthetic fistulas. AngioSculpt PTA Scoring Balloon Catheter, 0.018 OTW product sizes (in millimetres) 4.0x20, 5.0x20 and 6.0x20 Documentation Brochure AngioSculpt Evo Product Brochure (1.0 MB) Specifications Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, the AngioSculpt PTA scoring balloon catheter offers 360 . The MB balloon had a mean diameter of 2.940.34 mm, a mean length . angiosculpt vs cutting balloon. Company Name: Spectranetics Corporation. The AngioSculpt has 1.5 times the linear blade length of the Cutting Balloon . Global Unique Device ID: M3702027201012. Limited slip differential operates differently and more effectively than either locking or open differentials. Spectranetics (NASDAQ: SPNC) announced it has received U.S. Food and Drug Administration 510(k) clearance for the AngioSculpt PTA Scoring Balloon Catheter in 7 and 8 millimeter (mm) diameter . Nominal Pressure The AngioSculpt Scoring Balloon Catheter ORDERING INFORMATION Catalog Number Balloon Diameter (mm) Balloon Length (mm) Guidewire Compatibility Guide Catheter Compatibility Catheter Length (cm) 2001-2010 2.0 10 . The product assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty. Any questions, please contact us at 888-416-2409 or info@eSutures.com. Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, the AngioSculpt PTA scoring balloon catheter offers 360 . nFor the 2.0, 2.5, 3.0 or 3.5 mm balloon catheter, size AngioSculpt 1:1x the reference vessel diameter (RVD). Version (Model) Number: 2027-2010. Spectranetics 2076-6040 AngioSculpt PTA Scoring Balloon Catheter, Balloon diameter 6 mm, Balloon length 40 mm, Sheath size 6F, Catheter length 137 cm, Guidewire compatibility 0.018", Box of 01. The AngioSculpt (Spectranetics-Philips) is a semicompliant balloon with three spiral rectangular Nitinol scoring elements, also available in a drug-coated version (AngioSculpt X, Spectranetics-Philips). These Lesion morphology, stent and lesion length, and reference vessel size did not affect DES expansion. Global Unique Device ID: 00813132021245. AngioSculpt PTA Scoring Balloon Catheter 7 & 8 mm diameters brochure (305.8 kB) AngioSculpt PTA Scoring Balloon Catheter brochure (1.8 MB) Specifications Show all specifications Drug-coated balloon, featuring EnduraCoat Technology Provides top-tier patency to treat common-to-complex lesions with a low drug dose, After PSM, a total of 174 pairs were enrolled. The products are ideally suited to treat the narrowing of the native or synthetic fistula, a surgically created conduit between an artery and vein used to remove and Traditional balloon angioplasty can result in complications like vessel dissection, poor luminal gain, lesion recoil, balloon slippage, and poor stent apposition. The AngioSculpt RX PTCA scoring balloon catheter delivers the proven advantages of the AngioSculpt system combined with a new, tapered tip design that enhances deliverability. The device is typically placed using a guidewire and guiding catheter, and its balloon is inflated by the infusion of liquid through it tubular body. The tube and balloon are typically made of polymer materials and the cutting/scoring elements are typically made of metal [e.g., nickel-titanium alloy (Nitinol)]. The inflation pressure was increased until full balloon inflation and . Four different sizes of the AngioSculpt Valvuloplasty Scoring Balloon Catheter were available with 18, 20, 22, 24 mm diameter 4.0 cm length balloons. PRODUCT DETAILS The Chocolate PTA balloon is a semi-compliant balloon that is encased in a nitinol-constraining structure, or cage, that allows for 1:1 vessel sizing. Request PDF | On Jan 1, 2009, Angel Snchez-Recalde and others published AngioSculpt PTCA Balloon Entrapment During Dilatation of a Heavily Calcified Lesion | Find, read and cite all the research . Please look at the company's files for the latest available data on . AngioSculpt PTA Scoring Balloon Catheter 7 & 8 mm diameters brochure (305.8 kB) AngioSculpt PTA Scoring Balloon Catheter Brochure (1.8 MB) AngioSculpt Scoring Balloon pilot study summary (671.9 kB) Specifikationer Show all specifications 1. Version or Model: 2001-3520. Company size 51-200 employees . Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease. Sheath size: 5F . The AngioSculpt PTA scoring balloon catheter in 7 and 8 millimeter diameter balloon sizes are ideally suited to treat the narrowing of the native or synthetic fistula. Media Gallery Features . The recall affects 17,682 AngioSculpt PTA scoring balloon catheters (OTW 0.018" Platform) of multiple sizes, including all sizes and lot codes for the following models: 2076-4020, 2076-5020, 2076 . Product Description. Device Recall AngioSculpt PTA Scoring Balloon Catheter. AngioSculpt PTCA Scoring Balloon Catheter RX - 3.5mm x 15mm x 137cm Spectranetics. AngioSculpt OTW PTA Scoring Balloon Catheter - 6.0mm x 20mm x 90cm Spectranetics. Model Number 2216-35100 ; Balloon diameter: 3.5 mm . In conclusion, in this observational, nonrandomized study, pretreatment with the AngioSculpt balloon enhanced stent expansion and minimized the difference between predicted and achieved stent dimensions. The result is an essential tool in the treatment of a wide range of coronary lesions, including in-stent restenosis (ISR) and type C lesions. When used for pre-dilatation prior to stenting, AngioSculpt has been proven to yield a 33%-50% greater . Currently, Boston Scientific, Medtronic, and Philips control the global . Although the improved designs, profiles, and flexibility of new-generation stents permit direct delivery in >80% of percutaneous coronary interventions, 1,2 we recently demonstrated that (1) directly deployed sirolimus-eluting and paclitaxel-eluting stents achieve on average only 70% of the diameter and area predicted by their compliance charts, and (2) almost 30% of them fail to achieve . Catheter length: 155 cm . that consist of a single type, model, class, size . Core lab angiographic analysis demonstrated high acute gain and INDICATIONS Club Car XRT 800 (2WD) Compact size and optional automotive-style. AngioSculpt PTA Scoring Balloon Catheter ordering information (330.1 kB) Brochure AngioSculpt PTA Scoring Balloon Catheter 7 & 8 mm diameters brochure (305.8 kB) AngioSculpt PTA Scoring Balloon Catheter Brochure (1.8 MB) AngioSculpt Scoring Balloon pilot study summary (671.9 kB) Tuotetiedot Show all specifications 1. Coronary Intervention. Primary and secondary patency was exceptionally . Device Name: AngioSculpt PTCA Scoring Balloon Catheter . Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Quantity: Decrease Quantity of AngioSculpt PTCA Scoring Balloon Catheter RX - 3 . Publication types Comparative Study . The AngioSculpt con- cal and intravascular ultrasound (IVUS) observations have sists of a semicompliant balloon surrounded by spiral nitinol suggested that complex lesions especially with severe cal- element, the purposes of which are to dilate and make a 'scor- cification frequently interfere with stent expansion. Toledo: . 21/07/2021 Emma Matrick Cardiology, Interventional Cardiology No comments. Scheinert D, Peeters P, Bosiers M, et al. The global coronary balloon catheters market size should keep a positive trajectory, reaching $3.5 billion by 2027, with the drug-eluting market segment representing the majority of the total market. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020. The result is an essential tool in the treatment of a wide range of coronary lesions, including in-stent restenosis (ISR) and type C lesions. Retrieved on April 07 2022 from Abbott product ordering information. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc. 4. A new angioplasty scoring balloon catheter (AngioSculpt) has recently been approved for the treatment of narrowings in coronary arteries. Brand Name: AngioSculpt PTCA Scoring Balloon Catheter. Panel A-B. The product assists physicians with a difficult patient set, targeting lesions in the haemodialysis access that are resistant to standard balloon angioplasty. This is a single-use device. 1). Conclusions The Disrupt CAD Study successfully enrolled a population with complex, calcified, obstructive coronary disease. Finally, use of an AngioSculpt scoring balloon facilitated lesion dilation and stenting of the lesion (G). For the 2.0, 2.5, 3.0, or 3.5 mm balloon catheter, size the AngioSculpt 1.0 x the reference vessel diameter (RVD). This scoring element can deliver up to 25x the force of a non-compliant balloon. Strong safety profile AngioSculpt Evo is class indicated to treat ISR and Type-C lesions, and calcified lesions. Part (REF) number: 2092-6020: All lot codes. The cage and the balloon expand simultaneously, so as the balloon unwraps, the cage prevents the balloon from catching on lesions and causing torsional stress and dissections. AngioSculpt PTA Scoring Balloon Catheter 7 & 8 mm diameters brochure (305.8 kB) AngioSculpt PTA Scoring Balloon Catheter Brochure (1.8 MB) AngioSculpt Scoring Balloon pilot study summary (671.9 kB) Specifications Show all specifications 1. Brand Name: AngioSculptPTCA Scoring Balloon Catheter. The AngioSculpt PTA scoring balloon catheter in 7 and 8 millimeter diameter balloon sizes are ideally suited to treat the narrowing of the native or synthetic fistula. Primary DI Number: 00813132022181. Class 1 Device Recall AngioSculpt PTA Scoring Balloon Catheter. Scoreflex NC is a focused force dilatation balloon with a dual-wire system which creates a safe and controlled plaque dilatation. Guidewire compatibility: . The AngioSculpt PTA scoring balloon catheter in 7 and 8 millimeter diameter balloon sizes are ideally suited to treat the narrowing of the native or synthetic fistula. 1. This device is designed to make a 'scoring . Company Name: Spectranetics Corporation. Quantity: Decrease Quantity of AngioSculpt PTCA Scoring Balloon Catheter RX - 2 . Multiple runs of in-stent rotablation were performed with upsizing the burr size up to 2.15 mm (green arrowhead) (F). Panel C-D. Orbital atherectomy for plaque modification (18 passes), that was complicated by crown fracture and . The AngioSculpt PTA scoring balloon catheter in 7 and 8 millimeter diameter balloon sizes are ideally suited to treat the narrowing of the native or synthetic fistula. Four different sizes of the AngioSculpt Valvuloplasty Scoring Balloon Catheter were available with 18, 20, 22, 24 mm diameter 4.0 cm length balloons. AngioSculpt can be used in treating fibro-calcific, bifurcation and ostial lesions. Unlocks niche in endovascular care with $150M market opportunity; Enables physicians to deliver precision, power, safety for hemodialysis fistula or graft COLORADO SPRINGS, Colo., June 24, 2015. For standard balloon usage, a dilatation of the target lesion was performed with an adequate balloon size after passing the stenosis or occlusion. UPC: Current Stock: 2. AngioSculpt Balloon Can be used in ISR and complex type-C lesions; Designed to drive outward expansion with up to 15-25 times the force of conventional balloons; . . Indeed, 12-month patency rates were encouraging after AngioSculpt scoring balloon angioplasty in a small cohort of patients with calcified infrapopliteal lesions . to tailor the device size to the vessel Two radiopaque markers indicate the working ends of the scoring balloon . The product assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty. The power to score with AngioSculpt scoring balloon catheter AngioSculpt's smart scoring balloon technology delivers a unique blend of controlled, effective dilatation . be decreased by matching the stent size appro-priately with the vessel, performing adequate lesion preparation and post-treatment dilatation of the stent as needed, utilizing adjunctive IVUS . Spectranetics 2076-4040 AngioSculpt PTA Scoring Balloon Catheter, Balloon diameter 4 mm, Balloon length 40 mm, Sheath size 6F, Catheter length 137 cm, Guidewire compatibility 0.018", Box of 01.

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