Angelo Vertti, 18 de setembro de 2022

. Other sizes available in both versions. 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)]. 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. Model Number 2216-35100 ; Balloon diameter: 3.5 mm . 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. nFor the 4.0, 5.0 or 6.0 mm balloon catheter, size AngioSculpt a minimum of 0.5 mm less than the reference vessel Appropriatly sizing AngioSculpt Scoring elements Multiple struts IN-DATE EXPIRED ALL Balloons - Spectranetics In-Date & Expired Spectranetics Balloons Click on the option you are seeking: - 2.00mm 2.50mm 3.00mm 3.50mm 4.00mm 5.00mm 6.00mm 7.00mm 8.00mm 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) Teknik zellikler Show all specifications 1. Media Gallery Features 1). Brand Name: AngioSculpt PTCA Scoring Balloon Catheter. The unique design of the WOLVERINE Cutting Balloon combines a proprietary atherotome and low pressure balloon design to directly address each of these complications. According to AngioScore, the new AngioSculpt devices incorporate longer (40 mm) balloons and scoring elements in diameters of 2, 2.5, 3, and 3.5 mm. Four different sizes of the AngioSculpt Valvuloplasty Scoring Balloon Catheter were available with 18, 20, 22, 24 mm diameter 4.0 cm length balloons. Scheinert D, Peeters P, Bosiers M, et al. UPC: Current Stock: 3. Scoreflex NC is a focused force dilatation balloon with a dual-wire system which creates a safe and controlled plaque dilatation. As the balloon inflates, the spiral wires score the lesion allowing the balloon . 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. AngioSculpt PTCA Scoring Balloon Catheter RX - 3.5mm x 15mm x 137cm Spectranetics. Global Unique Device ID: M3702027201012. II. These No. performance, size, and composition within limits set by the . The design of the system is intended to minimize balloon slippage during inflation and facilitate a more optimal valvuloplasty result with an improved aortic valve area, and a more durable . Catalog Number: 2001-3520. Model / Serial. UPC: Current Stock: 2. Club Car XRT 800 (2WD) Compact size and optional automotive-style. 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. Class 1 Device Recall AngioSculpt PTA Scoring Balloon Catheter. (ISR) lesions, the inflated diameter size of the balloon should approximate the vessel diameter size just proximal and distal to the stenosis, in order to reduce potential vessel damage. This device is designed to make a 'scoring . Please look at the company's files for the latest available data on . Company Name: Angioscore Inc.. that consist of a single type, model, class, size . 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. 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. Version or Model: 2001-3520. The company stated that these new sizes are expected to be particularly useful in treating lesions typically encountered in the treatment of complex peripheral artery disease below the knee. nFor the 2.0, 2.5, 3.0 or 3.5 mm balloon catheter, size AngioSculpt 1:1x the reference vessel diameter (RVD). Brand Name: AngioSculptPTCA Scoring Balloon Catheter. $40.00) Model #: 2200-3515 OEM: Spectranetics Expiration Date: 2020-2021 Size: 3.5mm x 15mm x 137cm . Device Identifier (DI) Information. Panel A-B. 1, pp. For the 4.0, 5.0, or 6.0 mm balloon catheter, size the AngioSculpt a minimum of 0.5 mm LESS than the reference vessel diameter (RVD). Primary DI Number: 00813132022181. Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease. The inflation pressure was increased until full balloon inflation and . AngioSculpt PTCA Scoring Balloon Catheter RX - 2.0mm x 6mm x 137cm Spectranetics. 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 . 29 . Quantity: Decrease Quantity of AngioSculpt OTW PTA Scoring Balloon Catheter - 6 . 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 . The study demonstrated a low MACE rate of 5.0% with minimal vascular complications. Commercial Distribution Status: In Commercial Distribution. Version (Model) Number: 2027-2010. 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. 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. For standard balloon usage, a dilatation of the target lesion was performed with an adequate balloon size after passing the stenosis or occlusion. 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. OR BROWSE ALL. The Lithoplasty balloon-based therapy resulted in 98% device success and facilitated100% stent delivery. Number Balloon diameter (mm) Balloon length (mm) Catheter length (cm) Guidewire compatibility Sheath size (F) Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, the AngioSculpt PTA scoring balloon catheter offers 360 . Multiple runs of in-stent rotablation were performed with upsizing the burr size up to 2.15 mm (green arrowhead) (F). $40.00) Model #: 2200-2006 OEM: Spectranetics Expiration Date: 2019-2021 Size: 2.0mm x 6mm x 137cm . Primary and secondary patency was exceptionally . Company Name: Angioscore Inc.. balloon surface, part of the balloon cones, and the scoring element of the AngioSculptX catheter at an average surface concentration of 3g/mm 2. A thorough description of the lesion characteristics can be found in Table 5. 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, 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. Final angiographic result . The product assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty. 5. Device Name: . 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. The product assists physicians with a difficult patient set, targeting lesions in the haemodialysis access that are resistant to standard balloon angioplasty. This device is designed to make a 'scoring . AngioSculpt OTW PTA Scoring Balloon Catheter - 6.0mm x 20mm x 90cm Spectranetics. 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. Model Number 2216-35100 . The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) is composed of a semicompliant balloon encircled by three nitinol spiral struts providing targeted lesion scoring on . Company Name: Spectranetics Corporation. 2. After PSM, a total of 174 pairs were enrolled. AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc. 4. All Locations: neutrogena rapid tone repair vitamin c capsules reviews. INDICATIONS When used for pre-dilatation prior to stenting, AngioSculpt has been proven to yield a 33%-50% greater . 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. Quantity: Decrease Quantity of AngioSculpt PTCA Scoring Balloon Catheter RX - 2 . The AngioSculptPTCA Scoring Balloon Catheter delivers the proven advantages of the AngioSculpt system combined with a new, tapered tip design that enhances deliverability. The AngioSculpt Scoring Balloon Catheter, shown in Figure 1, is a standard PTCA catheter with a scoring balloon near the distal tip. Catheter Cardiovasc Interv. Finally, use of an AngioSculpt scoring balloon facilitated lesion dilation and stenting of the lesion (G). to tailor the device size to the vessel Two radiopaque markers indicate the working ends of the scoring balloon . The AngioSculpt Scoring Balloon Catheter significantly alters the landscape for treating both peripheral arterial disease (PAD) and coronary artery disease (CAD). Brand Name: AngioSculptPTCA Scoring Balloon Catheter. AngioSculpt Evo provides the precision and power required to deliver more luminal gain with minimal risk to safely dilate resistant lesions.1,2,5 Edges lock in devices Provides the largest effective scoring area of any specialty balloon.1 1Delivers up to 25X the force of non-compliant balloons. Background Restenosis remains a problem in hemodialysis access interventions. size 2039-2010 2 mm 10 mm 137 cm 0.014" 5F 2039-2020 2 mm 20 mm 137 cm 0.014" 5F 2155-2040 2 mm 40 mm 155 cm 0.014" 5F The AngioSculpt (AngioScore Inc., Fremont, CA, USA) was developed as a coronary interventional device, which consists of a semi-compliant balloon surrounded by spiral nitinol element that works in tandem with the balloon in order to 'score' the target lesion upon balloon inflation 1, 2 (Fig. Global Unique Device ID: 00813132021245. 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. Guidewire compatibility: . . Device Name: AngioSculpt PTCA Scoring Balloon Catheter . Quantity: Decrease Quantity of AngioSculpt PTCA Scoring Balloon Catheter RX - 3 . 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. Version (Model) Number: 2200-3515. Therefore, the use of scoring balloon angioplasty might be more suitable in the presence of significant vascular calcification. When used to 4 89% of the vessels predilated with AngioSculpt had final stent area 5.0 mm2 compared to 74% for direct stenting or pre-dilatation with a conventional balloon.4 Larger luminal gain 0.0 0 0.2 . The AngioSculpt catheter incorporates a nitinol device that consists of spiral wires that wrap around the balloon catheter. 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 AngioSculpt has 1.5 times the linear blade length of the Cutting Balloon . UPC: Current Stock: 2. 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). 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. Vehicle Rated . Company Name: Spectranetics Corporation. 2007;70:1034-1039. AngioSculpt The longer length of Philips AngioSculpt provides more coverage and convenience for infrainguinal artery procedures, but it's the unique advantage of the AngioSculpt scoring technology that really delivers. The power to score with AngioSculpt scoring balloon catheter AngioSculpt's smart scoring balloon technology delivers a unique blend of controlled, effective dilatation . 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; . The AngioSculpt (AngioScore Inc., Fremont, CA, USA) was developed as a coronary interventional device, which consists of a semi-compliant balloon surrounded by spiral nitinol element that works in tandem with the balloon in order to 'score' the target lesion upon balloon inflation 1, 2 (Fig. . 3. The AngioSculpt Scoring Balloon Catheter is comprised of a semi-compliant angioplasty balloon surrounded by a nitinol scoring element. Challenging PCI for balloon undilatable ostial right coronary artery (RCA) chronic total occlusion (CTO). 1). "The AngioSculpt Scoring Balloon Catheter, now in sizes appropriate for a larger range of vessel diameters, has the potential to address the most difficult problems we encounter in treating AV . Bosiers et al, Use of the AngioSculpt Scoring Balloon for Infrapopliteal Lesions in Patients with Critical Limb Ischemia: 1-year Outcome Vascular, Vol. Product Description. Long-term outcome upon treatment of calcified lesions of the lower limb using scoring angioplasty balloon (AngioSculpt) . The prevalence, treatment and outcomes of balloon undilatable chronic total occlusions (CTOs) have received limited study. AngioSculpt can be used in treating fibro-calcific, bifurcation and ostial lesions. Contact us Designed specifically to address long, diffuse lesions commonly found in infrainguinal arteries, the AngioSculpt PTA scoring balloon catheter offers 360 . Catheter length: 155 cm . Clinical studies show 0% Final D-E-F dissection rates*. Indeed, 12-month patency rates were encouraging after AngioSculpt scoring balloon angioplasty in a small cohort of patients with calcified infrapopliteal lesions . | March 2, 2022 Device Name: . 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 . Publication types Comparative Study . Toledo: . the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.The catheter system should be used only by physicians . Currently, Boston Scientific, Medtronic, and Philips control the global . Brand Name: AngioSculptPTCA Scoring Balloon Catheter. 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 A new angioplasty scoring balloon catheter (AngioSculpt) has recently been approved for the treatment of narrowings in coronary arteries. Conclusions The Disrupt CAD Study successfully enrolled a population with complex, calcified, obstructive coronary disease. 21/07/2021 Emma Matrick Cardiology, Interventional Cardiology No comments. 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). 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. Pre-dilatation with AngioSculpt yielded 33% - 50% greater luminal gain than direct stenting or pre-dilatation with a conventional angioplasty balloon. Two simultaneous balloon inflations (green arrows) also failed to expand the lesion (E). Company size 51-200 employees . AngioSculpt PTA Scoring Balloon Catheter, 0.018" OTW Various product sizes: 4.0 x 20 mm, 5.0 x 20 mm and 6.0 x 20 mm The recall is being initiated because of a small number of reports from the field of distal bond failure resulting in peeling of the bond and/or detachment of the distal end of the scoring element. Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. $40.00) Model #: 2092-6020 OEM: Spectranetics Expiration Date: 2018 Size: 6.0mm x 20mm x 90cm . . Bumper Tip 2. 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. AngioSculpt catheter from the sterile package and place on the sterile field. 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 vs cutting balloon. 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. 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). AngioSculpt scoring balloon catheter: coronary & peripheral interventions device evaluation brachytherapy demonstrated considerable prom-ise in . 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. 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 . 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 . Balloon length: 100 mm . Device Recall AngioSculpt PTA Scoring Balloon Catheter. angiosculpt vs cutting balloon. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020. 41,42 In a feasibility trial, the AngioSculpt balloon was used for the treatment of de novo lesions prior to BMS implantation and showed very . Part (REF) number: 2092-6020: All lot codes. 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 . 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). (D). 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. Core lab angiographic analysis demonstrated high acute gain and These struts create focal amplification of the forces exerted by the valvuloplasty balloon along the edges of the scoring element (up to 20 times). The product assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty. Documentation Brochure AngioSculpt Evo Product Brochure (1.0 MB) Specifications . AngioSculpt PTA Scoring Balloon Catheter, 0.018 OTW product sizes (in millimetres) 4.0x20, 5.0x20 and 6.0x20 This is a single-use device. Coronary Intervention. The product assists physicians with a difficult patient set, targeting lesions in the hemodialysis access that are resistant to standard balloon angioplasty.

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