cutting balloon boston scientific
Maverick XL Balloon diameters include: 4.0, 4.5, 5.0, 5.5, and 6.0mm. The unique design of the WOLVERINE Cutting Balloon combines a proprietary atherotome and low pressure balloon design to directly address each of these complications. BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC FLEXTOME CUTTING BALLOON 3.0MM X 15MM: Back to Search Results: Catalog Number CBM330015: Device Problem Material Separation (1562) Patient Problems Bradycardia (1751); Pyrosis/Heartburn (1883) Event Date 02/11/2013: A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g., microsurgical . The .035-inch exchange guide wire was then exchanged for a .018-inch guide wire (Terumo) to allow placement of an 8-mm-diameter, 2-cm-long cutting balloon catheter (Peripheral Cutting Balloon, Boston Scientific, Natick, Massachusetts) with four blades across the stricture. Hypotube/Corewire Assembly 7. The Cutting Balloon Device is a proven tool for the mechanical challenges of complex lesions that are often resistant to conventional balloon angioplasty. Physicians Who May Use BOSTON SCIENTIFIC CORPORATION - 2cm Peripheral Cutting Balloon Back to Top This sample data is for Yale New Haven Hospital & shows the top physicians that may be impacted by use of 2cm Peripheral Cutting Balloon by BOSTON SCIENTIFIC CORPORATION. scoring balloons are believed to decrease elastic recoil and plaque shifting, potentially reducing the need for two stents in the case of bifurcations. RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA) . The use of cutting balloon is hindered by problems with crossability; however, a novel cutting balloon (Wolverine, Boston Scientific, Natrick, MA, USA) with potentially better crossability was recently developed. Patients with signs of AV access failure who are found to have significant stenosis (more than 50%) at the venous end of the anastomosis will then be randomized to either high pressure balloon (Conquest) or to a cutting balloon (Boston scientific Balloon). The Flextome Cutting Balloon is available in diameter sizes ranging from 2.0 to 4.0 mm . Boston Scientific. Ordering Information 0.018" Peripheral Cutting Balloon Over-the-Wire Reimbursement The C-code used for this product is C1725, catheter, transluminal angioplasty, non-laser (may include guidance, infusion/perfusion capability). The cutting balloon (CB) was first designed and reported by Barath et al. Small Peripheral Cutting Balloon Microsurgical Dilatation Device - Monorail - 3.0mm x 1.5cm x 142cm Boston Scientific. Use in coronary arteries. Manifold Technology Overview 2. scoring/cutting balloon, other debulking devices, etc.) Atherotomes 3. 3. C-codes are used for hospital outpatient device reporting for Medicare and some private payers. The rotablator (Boston Scientific, Natick, MA) is an over-the-wire system that consists of a nickel-plated diamond-coated brass burr attached to a drive shaft, which can achieve speeds up to 200,000 rpm driven by compressed gas ( Fig. 00cm x 90 cm peripheral cutting balloon was selected and advanced to treat the target lesion. Add to Cart. The 20- to 30-m-sized diamond chips are located only on the front half of the olive-shaped burr. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729888246 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 . Boston Scientific Announces FDA Clearance for Peripheral Cutting Balloon Microsurgical Dilatation Device. The Cutting Balloon, AngioSculpt, Serranator, and NSE are the available scoring balloons for the treatment of femoropopliteal lesions. Cutting balloon has four blades surrounding the balloon, which can cut the plaque. Balloon pressure should not exceed the rated burst pressure. UPC: Current Stock: 4. A, The Flextome CB. $3.00 box of 1 - Boston Scientific # PCB802050 - Boston Scientific Peripheral Cutting Balloon OTW 8mm x 20mm, 50cm Boston Scientific, PCB802050, 8.00mm, Boston Scientific Peripheral Cutting Balloon OTW 8mm x 20mm, 50cm - eSutures CUTTING BALLOON Boston Scientific Scimed, Inc. USPTO Trademarks Boston Scientific Scimed, Inc. Manifold Technology Overview The rated burst pressure is based on the results of in vitro testing. To get physicians impacted for your Hospital, click here. WOLVERINE Cutting Balloon. From Boston Scientific The Flextome Cutting Balloon Device consists of a balloon with three to four microsurgical blades (atherotomes) mounted lengthwise on its outer surface. Proximal Marks 6. PRACTICAL POINTS. Manufacturer Reason. Midshaft 5. The cutting balloon was removed with the previously implanted ion stent attached. On inflation of. Download Free Product Brochure Home Media Center Press Releases. Z-Glide Hydrophilic Coating 4. Your preferences will apply to this website only. December 8, 2005. Power: ~15 - 25x scoring force. $30.00) Model #: PCBM3015140F OEM: Boston Scientific Expiration Date: 2018-2021 Size: 3.0mm x 1.5cm x 142cm . Peripheral vascular cutting balloon from Boston Scientific. This video was created for a medical device manufacture and the process they go through for each and every product. Data will be collected . Long ( 20 cm) total occlusions. Boston Scientific has voluntarily recalled all of its Flextome balloon-cutting systems, which are used to help open blocked arteries, because of reported flaws with the device. Two variations on the same theme have become available: Cutting Balloon (Boston Scientific Corporation, Natick, MA) and AngioSculpt (Angioscore, Inc., Freemont, CA). The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. 1. globe symbol in word the rotational Jetstream atherectomy system (Boston Scientific Corporation) is used to create a channel and gain a larger vessel lumen prior to adjunctive the . The unique design of the WOLVERINE Cutting Balloon combines a proprietary atherotome and low pressure balloon design to directly address each of these complications. The cutting balloon was inflated three times (1st inflation 7atm, 2nd 7atm and the 3rd 11atm). Patients with vessels that failed to sufficiently dilate were then randomized to high-pressure angioplasty (15-22 atm; n = 66 vessels) or treatment with a cutting balloon (n = 107; Boston Scientific, Natick, MA) followed by additional low-pressure dilation. . . for Recall. 13-9 ). The cutting balloon (Boston Scientific Corporation, Natick, MA) was introduced in the early 1990s . Coronary angioplasty balloon catheter, cutting/scoring A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and . The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas. Widest Range of Diameters: The Maverick XL Balloon Catheter joins the Maverick Monorail Balloon Catheter to provide the broadest size offering of any coronary balloon catheter line (1.5-6.0mm diameters). Treat challenging lesions with the flexible, deliverable and predictable Flextome Cutton Balloon Device. Upon removal resistance was felt. Built for big challenges. during the index procedure; History of major . The cutting balloon allows for efficient calcification expansion by concentrating the stresses in the blade. 1. After visualization of the stricture with a urethroscope or cystoscope (Fig. Dependent on rated burst pressure of balloon used: 0.014, 0.018, 0.035: 100, 200, 300: Dependent on the introducer compatibility of the balloon used: Unlimited: Compatible with balloon lengths of 20-300 mm [] in 1991.The CB (Boston Scientific, Natick, initially distributed by InterVentional Therapeutics) was approved as a treatment modality for coronary "high-pressure, balloon-resistant lesions" including de novo lesions and in-stent restenosis (ISR) [] in 1995.Originally developed for the coronary field, where many . This balloon has small cutting blades along its outer surface to help cut plaque and perform angioplasty. 4.. Maverick2 XL Monorail Balloon Catheter. Wholesale Trader of Boston Scientific - Maverick Boston Balloons Catheter, CLS3 Guiding Catheter, Amplatz Super Stiff and Pushable Coil offered by Marlins Medico, New Delhi, Delhi. Kallie Iverson. The first of the atherotomy (scoring) devices to be developed was the cutting balloon (Flextome Cutting Balloon, Boston Scientific, MA, USA). . Cutting Balloon Device, because of its mechanism of action, may pose a greater risk of perforation than that observed with conventional PTA. 10 ATM expands your treatment options. To reduce the potential for vessel damage the inflated diameter of the Peripheral Cutting Balloon Device should not exceed a 1.1:1 ratio of the diameter of the vessel just proximal and distal to the stenosis. (August 25, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market . 2), the stricture was passed using a .018-inch guidewire (Thruway Guidewire; Boston Scientific, Natick, MA), and an 8.0 2.0-cm cutting-balloon catheter (Peripheral Cutting Balloon, Boston Scientific) with four microtomes was advanced over the . Z-Glide Hydrophilic Coating 4. Follow on Twitter; Follow on LinkedIn; Boston Scientific is dedicated to transforming lives through innovative medical solutions that . The Flextome Cutting Balloon (Boston Scientific, US) is the latest incarnation of the original Barath design and is sized from 2.0 to 4.0 mm in quarter sizes.The deflated profile is from 0.041 to 0.046", the atherotome lengths are either 6, 10 or 15 mm and the distal shaft is 3.2 F ().The changes to balloon material and the incorporation of flex points every 5 mm for the 10 . B, A magnified 2-cm-long Peripheral CB device deflated and inflated. A cutting balloon, buddy wire balloon, buddy wire, or DES (including sirolimus-eluting stent, paclitaxel-eluting stent, everolimus-eluting stent,zotarolimus-eluting stent) was implemented at the discretion of the operator in both groups. Power: ~15 - 25x scoring force. There is a small peripheral cutting balloon using a 0.014" system . Boston Scientific. Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical . Proximal Marks 6. $30.00) Model #: PCBO4015140F OEM: Boston Scientific Expiration Date: 2020 Size: 4.0mm x 1.5cm x 137cm . WOLVERINE Cutting Balloon delivers industry-leading performance with: improved crossability and deliverability, precise, controlled cutting, and a proven mechanism of action. Boston Scientific 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting . Add to Cart . Please note that some processing of your personal data may not require your consent, but you have a right to object to such processing. Model #: 49-280 Thruway Short Taper Guide Wire - .018" x 190cm $25.00. It requires a 6 or 7F sheath. Oversizing increases the risk When the device is inflated, the atherotomes score the plaque by severing the elastic and fibrotic continuity of the vessel with tiny incisions. The device contains three or four stainless steel blades mounted longitudinally on a noncompliant balloon, which protrude 0.127 mm outside the balloon surface during inflation and which act to score tissue [4] and greatly enhance the transmitted . . From Boston Scientific . UPC: Current Stock: . https://www.bioz.com/result/10 mm flextome cutting balloon/product/Boston Scientific Average 86 stars, based on 1 article reviews Price from $9.99 to $1999.99 10 mm flextome cutting balloon - by Bioz Stars , 2022-09 86 / 100 stars Buy from Supplier 3 5 mm flextome cutting balloon ( Boston Scientific ) 85 00mm x 2. Hypotube/Corewire Assembly 7. Cutting Balloon Ultra2 Device Flextome Cutting Balloon Device 328.9 230.7 Flexpoints: 6mmlength=0 10mm length = 1 15mm length = 2 Flexpoints located every 5mm on 10mm and 15mm lengths 5mm 0.004" Atherotomes with Flexpoints assist in tracking to lesions that may have been previously out of reach * Bench testing and cadaver testing conducted by . The leading edges are designed to drive outward expansion with up to ~15-25 times the force of a conventional balloon AngioSculpt's helical nitinol element creates a uniform initial luminal enlargement. The Cutting Balloon Device is a proven tool for the mechanical challenges of complex lesions that are often resistant to conventional balloon angioplasty. 300 Boston Scientific Way Marlborough, MA 01752-1234 www.bostonscientific.com To order product or for more information . The Flextome Cutting Balloon Device consists of a balloon with three to four microsurgical blades (atherotomes) mounted lengthwise on its outer surface. (March 15, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Quincy Distribution Center as a sterilization site for its Cutting Balloon microsurgical dilatation device product line. Developed in the early 1990s, the cutting balloon Click here for more information. It was reported that a cutting balloon blade was partially lifted. Cutting Balloon Application #78238847 Application Filed: 2003-04-17 Trademark Application Details Status Refresh 800 Live/Registered REGISTERED AND RENEWED Research OneLookAcronym Finder Serial Number 78238847 Registration Number 2904754 5 x24 ion stent in the lesion. Bumper Tip 2. whereas none occurred in those treated with the Cutting Balloon (Boston Scientific Corporation). The procedure was completed with another of the same device. Given the similar diameter of coronaries and infrapopliteal vessels, it was a logical . 50% improvement in re-cross compared to the Cutting Balloon Ultra Device 1 The Predictability You Rely On Precise dilatation Scoring the plaque by severing the elastic and fibrotic continuity of the vessel wall Dilating the lesion at lower pressures with less recoil Lumen gain through plaque compression instead of vessel wall expansion All of these received low-pressure ( 8 atm) balloon dilatation. Boston Scientific 1410006 . Peripheral Cutting Balloon Microsurgical Dilatation Device Rated Burst Pressure: *Please contact your local Boston Scientific representative for product availability in your respective country. For Additional Information Contact. a guidewire will not pass. Cutting Balloons (CB; Boston Scientific, Inc, Natick, MA) are noncompliant balloons with atherotomes (microsurgical blades) mounted longitudinally on their outer surface. GMDN Preferred Term Name GMDN Definition; Coronary angioplasty balloon catheter, cutting/scoring: A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery and increase myocardial perfusion, by controlled inflation of a distensible balloon at its distal tip with peripheral cutting/scoring elements (e.g . 763-494-2042. When compared to balloon angioplasty with or without coronary stenting, ablative devices including coronary atherectomy (both directional and rotational), laser angioplasty, or cutting balloon angioplasty failed to . The physician then pre-dilated the lesion using a 2. Boston Scientific, MA, USA) in . 5 x20 mm non-bsc balloon and was able to deploy a 2. Angiograms will then be performed before and after intervention. A 6. Ships Today! A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous . The Flextome Cutting Balloon (Boston Scientific), introduced in 1991, is available in monorail or over-the-wire catheter, with the most recent iteration (Wolverine) improved in terms of profile and flexibility. Kumpe catheter boston scientific; kenmore dryer belt model 110; pa mine map; swollen lymph nodes in neck; 2006 monte carlo transmission replacement; shoulder brace for tendonitis; why i am a hindu pdf; turmeric for horses sarcoids. When a cutting balloon is used, if the calcified lesion cannot be expanded in a single dilation, dilation success may be achieved after the balloon is rotated and the position of the blade is changed. Bumper Tip 2. Small Peripheral Cutting Balloon Microsurgical Dilatation Device - OTW - 4.0mm x 1.5cm x 137cm - Non-Expired $60.00. Scheinert et al 5 applied the AngioSculpt (Philips Healthcare, Best, the Netherlands) in infrapopliteal . Wolverine Coronary Cutting Balloon - GMDN. . When the device is inflated, the atherotomes score the plaque by severing the elastic and fibrotic continuity of the vessel with tiny incisions. Midshaft 5. News Releases - Boston Scientific. CUTTING BALLOON The Cutting Balloon was originally introduced for coronary intervention. The recall of roughly 40,000 devices affects the Flextome Cutting Balloon Device Monorail Delivery System and Peripheral Cutting Balloon Microsurgical . During the procedure, it was noted that a piece of metal was sticking out of the balloon. Device. Atherotomes 3. Quantity: . azur lane equipment guide imgur; charthouse james island; bintelli 50cc scooter; wales weather by month; i . The cutting balloon was positioned at the lesion site (using predilation with a small conventional balloon in case of unsuccessful passage) and inflated to the recommended . It uses a 0.018 inch wire and is available from 5 to 8mm diameters in a 2cm length. Angiography showed severe stenosis of the proximal lpa, with improvement post balloon dilation with an 8mm cutting balloon angiographically and no extravasation or aneurysm seen. Safety: Low dissection rate,. Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate 02/19/20. Designed for multiple Indications The Peripheral Cutting Balloon device is designed for multiple indications: FLEXATOME CUTTING BALLOON: Generic Name: catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring: Applicant: Boston Scientific Corp. one scimed place maple grove, MN 55311-1566: PMA Number: P950020: Date Received: 06/26/1995: Decision Date: 04/18/2000: Product Code: NWX : Docket Number: 00M-1298: Advisory Committee . Treat . Cutting balloon designed for opening coronary arteries in circumstances where resistant lesions are encountered and unable to be opened with traditional balloon angioplasty Balloon combines arthrotome and low-press design to help prevent vessel dissection, poor luminal gain, lesion recoil, balloon slippage and poor stent apposition The cutting balloon device (Boston Scientific Corp.) was a 10- to 15-mm-long cutting balloon selected with the same or 0.25- to 0.5-mm larger diameter than the vessel size.
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