CAS However, imaging is the key to ensuring adequate safety and understanding the underlying mechanism of failure. When dealing with extensive and thick calcifications, we acknowledge the need of other technologies, such as rotational atherectomy and lithotripsy. The balloons used in the experiment were provided by Boston Scientific. Arizona Maru. Muramatsu T, Tsukahara R, Ho M, et al. Arteriosclerosis. This is a preview of subscription content, access via Cutting balloon inflation for drug-eluting stent underexpansion due to unrecognized coronary arterial calcification. Current Treatment Modalities for Calcified Coronary Artery Disease: A Review Article Comparing Novel Intravascular Lithotripsy and Traditional Rotational Atherectomy. 2023 Boston Scientific Corporation or its affiliates. Mauri L, Bonan R, Weiner BH, et al. This study aimed to explore the optimal method of dilation of highly calcified lesions using a cutting balloon. In case of in-stent restenosis, when the stent size is known, the cutting balloon should be sized 1:1 or upsized to 0.25 mm. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. Interv Cardiol Rev. Cardiovasc Revascularization Med. 2006;7:1858. Treating complex lesions with traditional balloon angioplasty can result in complications like vessel dissection, poor luminal gain, lesion recoil, balloon slippage, and poor stent apposition.The unique design of the WOLVERINE Cutting Balloon combines a proprietary atherotome and low pressure balloon design to directly address each of these complications. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. Unauthorized use of these marks is strictly prohibited. Experimental models have demonstrated that traditional angioplasty with standard balloons in fibrotic lesions can hardly create dissections.4 Cutting balloons use atherotomes to score through the fibrosis, thus favoring a better lesion preparation. Circ J. Yeoh J, Cottens D, Cosgrove C, Mallek K, Strange J, Anderson R, et al. In conclusion, implanted stents significantly increase the difficulty of balloon dilation and adequate pretreatment is critical for successful coronary stenting. 2019;14:15463. your institution. Take an in-depth look at the R&D process. Peripheral Cutting Balloon (PCB) is designed to minimize vessel trauma with its unique mechanism of action. The cutting balloon has been demonstrated to better prepare lesions in case of in-stent restenosis. 10 March 2017. 2019;94:936-944. doi: 10.1002/ccd.28278, 7. Google Scholar. The use of cutting, scoring, and very high-pressure balloons can result in better PCI outcomes in selected cases, especially in combination with intravascular imaging. Learn more about the Modern PCI approach to improving patients' outcomes. Considering the aggressive nature of this approach, we suggest the use of intravascular imaging to appropriately size the balloon. Utility of a scoring balloon for a severely calcified lesion: bench test and finite element analysis. Amemiya K, Yamamoto MH, Maehara A, et al. Zhu X, Umezu M, Iwasaki K. Finite element analysis of the cutting balloon with an adequate balloon-to-artery ratio for fracturing calcification while preventing perforation. Circ J. Arizona. Catheter Cardiovasc Interv. Not just once but for all. $27. 2004;43:943-949. doi: 10.1016/j.jacc.2003.09.054, 3. Having taken the steps to see and prep coronary arteries, you now have a suite of market-leading therapies at your fingertips to handle any form of coronary artery disease. Incidence, predictors and outcome of thrombosis after successful implantation of drug-eluting stents. Feasibility and safety of orbital atherectomy for the treatment of in-stent restenosis secondary to stent under-expansion. Leick J, Rheude T, Denne M, Cassese S, Kastrati A, Hauptmann F, Gehrig T, Kuna C, Lindner M, Lauterbach M, Werner N. Front Cardiovasc Med. The Wolverine cutting balloon (Boston Scientific, Fig. IRCCS Humanitas Research Hospital, Rozzano Looking forward for more data to support this strategy @GreggWStone @mirvatalasnag @RodrigoBagur @mmamas1973 @Costa_F_8" Sponsor. J Geriatr Cardiol. Evidence from small intravascular ultrasound (IVUS)guided PCI studies for in-stent restenosis suggest that the use of cutting compared to traditional balloons is associated with larger lumen gain, lower lumen loss, and preserved good angiographic result at follow-up.1 However, a randomized study comparing standard balloons versus cutting balloons for the treatment of in-stent restenosis failed to demonstrate superiority of the cutting balloon in terms of recurrent in-stent restenosis and major adverse cardiac events.2 Nevertheless, the presence of blades on the cutting balloon surface can potentially improve the intravascular diffusion of antiproliferative agents delivered with modern drug-coated balloons, thus favoring sustained long-term results. Asakura Y, Furukawa Y, Ishikawa S, Asakura K, Sueyoshi K, Sakamoto M, et al. 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)]. sharing sensitive information, make sure youre on a federal Proc Inst Mech Eng H. 2023 Apr;237(4):443-450. doi: 10.1177/09544119231157853. 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. Article Tang Z, Bai J, Su SP, Wang Y, Liu MH, Bai QC, et al. 1995;92:1355-1374. doi: 10.1161/01.cir.92.5.1355, 4. PMC Federal government websites often end in .gov or .mil. Description. We pay our respects to them and their cultures, and to all Elders both past and present. Cutting balloons are commonly used to treat patients with coronary artery disease (CAD) presenting with calcified lesions, but the efficacy of cutting balloons has not been elucidated. In the bench test, the dilation success rate of the Wolverine cutting balloon was higher and the maximum dilation pressure required was lower (p<0.01 in all analyses), compared with that of the NC Emerge balloon catheter. 3. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Wolverine Coronary Cutting Balloon : Product Information, BOSTON SCIENTIFIC CORPORATION - Wolverine Coronary Cutting Balloon : Product Code Information, BOSTON SCIENTIFIC CORPORATION - Wolverine Coronary Cutting Balloon : Reimbursement Data & Quality Outcomes, Inpatient (For Included Categories & DRGs), Surgical (For Included Categories & DRGs), Back to Reimbursement Quality Outcomes Summary, Labeling does not contain MRI Safety Information, Coronary angioplasty balloon catheter, cutting/scoring. This material not intended for use in France. Cardiovasc Revascularization Med. Arimasan Maru. On the contrary, its use in the presence of calcified nodules requires attention due to the nonnegligible risk of vessel rupture. Antonio Colombo, MD Spanish +34 91 153 81 81 https://doi.org/10.1007/s12928-021-00803-5, DOI: https://doi.org/10.1007/s12928-021-00803-5. More from This Artist Similar Designs. Effect of cutting balloon after rotational atherectomy in severely calcified coronary artery lesions as assessed by optical coherence tomography. However, evidence regarding its use is limited to case reports. Because the profile of the scoring balloon is slightly better than cutting, we tend to use it in more challenging scenarios when cutting has low probability to be delivered. Cardiovasc Interv and Ther 37, 7888 (2022). WOLVERINE Coronary 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: Supplement Number: S117: Date Received: 02/11/2022: Decision Date: 03/09/2022: Product Code: NWX : Advisory . 3D printer; Calcified lesion; Computer simulation; Cutting balloon; Finite element analysis. 7. https://doi.org/10.1007/s12928-013-0232-6. A study of balloon type on calcified coronary lesion predilation: A finite element analysis. The cutting balloon creates sagittal cuts that favor the extrusion of intimal hyperplasia through stent struts. Circ Rep. 2021;3:18. Nevertheless, procedural success was numerically higher in the super noncompliant balloon group, possibly related to a different deliverability of the two devices.8. Andrew Read. doi: 10.1371/journal.pone.0251404. Cahalane RM, Barrett HE, OBrien JM, Kavanagh EG, Moloney MA, Walsh MT. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Previous Article, By Mattia Lunardi, MD, MSc, and Flavio Ribichini, MD. Forces amplified 3x at atherotomes, precisely fracturing calcium at lower balloon inflation pressures. 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. Epub 2021 Aug 10. Article The OPN balloon (SIS Medical AG) is a double-layer balloon with minimal dog-boning effect and an optimal resistance to deformation, which guarantees a preserved balloon diameter even at the highest inflation rates. The maximum first principal stresses in calcified lesions were also evaluated by computer simulation using the finite element method. No data are available regarding the treatment of in-stent restenosis with use of the OPN. Incidence, predictors and outcome of thrombosis after succesful implantation of drug-eluting stents. WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE) 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: Supplement Number: S072: Date Received: 01/29/2016: Decision Date: 08/18/2016: Product . Incidence, predictors and outcome of thrombosis after succesful implantation of drug-eluting stents. 1998;44:4202. The Wolverine coronary cutting balloon (Boston Scientific, Marlborough, MA) is available in size 2.00-3.25 mm (balloon diameter models with three atherotomes) or 3.5-4.0 mm (balloon with four atherotomes) which cut into plaque creating initiation sites for crack propagation. Clearer images of coronary arteries make for clearer treatment decisions. 8. Calcified lesions. Note: If you need help accessing information in different file formats, see It consists of a balloon that, when inflated, presses multiple atherotomes (up to 4) against the vessel wall, thus producing controlled longitudinal incisions. Song X, Adachi T, Kawase Y, Kimura T, Saito N. Efficacy of the Wolverine cutting balloon on a circumferential calcified coronary lesion: bench test using a three-dimensional printer and computer simulation with the finite element method. 2005;293:212630. Neupane S, Basir M, Tan C, Sultan A, Tabaku M, Alqarqaz M, et al. We prepared 3 different scoring devices [Wolverine Cutting Balloon (CB), ScoreFlex NC (SF . (a) (b) (c) (d) CAS 2023 May 15;10:1185422. doi: 10.3389/fcvm.2023.1185422. The balloon can be inflated up to 35 atm with minimal risk of balloon rupture. We aimed to investigate the impact of novel cutting balloons (Wolverine) relative to conventional balloons on post-interventional stent expansion for coronary calcified lesions. Efficacy of the Wolverine cutting balloon on a circumferential calcified coronary lesion: Bench test using a three-dimensional printer and computer simulation with the finite element method . Finite element analysis of cutting balloon expansion in a calcified artery model of circular angle 180: Effects of balloon-to-diameter ratio and number of blades facing calcification on potential calcification fracturing and perforation reduction - PMC Back to Top Skip to main content An official website of the United States government 2023 Boston Scientific Corporation or its affiliates. Successful management of a resistant, focal calcified lesion following direct coronary stenting with a cutting balloon. We would like to thank Mr. Hideo Yamada (Free Radical Inc.) for the guidance of the design of the stent and the structural analysis of this study. Use of the OPN balloon can be considered in stent underexpansion and calcified lesions. Instructions for Downloading Viewers and Players. 2005;45:9958. Circ J. We would like to express our deepest gratitude to them. The characteristics of each scoring balloon seem to be different because material or configuration of scoring element in each device is unique. Google Scholar. Calcification models were developed from patient Efficacy of the Wolverine cutting balloon on a circumferential calcified coronary lesion: Bench test using a three-dimensional printer and computer simulation with the finite . 1998;44:4202. Stary HC, Chandler AB, Dinsmore RE, et al. Efficacy of cutting balloon angioplasty for in-stent restenosis: an intravascular ultrasound evaluation. Generic Name. $27. Cardiovascular Intervention and Therapeutics (2019) 34:325334 Therefore, this study aimed to investigate in-stent dilation in circumferential coronary calcifications using Wolverine cutting balloons . J Am Med Assoc. Biomed Eng Online. Contemporary approach to heavily calcified coronary lesions. Wolverine red eyes edit Drawing. CROSSBOSS Coronary CTO Crossing Catheter, STINGRAY LP Coronary CTO Re-Entry System, NC QUANTUM APEX PTCA Dilatation Catheter, Quick reference guide with order codes for all Interventional Cardiology products, Browse all coronary and peripheral devices. The following are two techniques for cutting balloon inflation: (1) nominal pressure with a balloon-to-vessel ratio of 1:1 or (2) high pressure using a cutting balloon downsized by 0.5 mm compared to the vessel media-to-media diameter. Antonio Mangieri, MD 2014;29:1349. Ferri LA, Jabbour RJ, Giannini F, Benincasa S, Ancona M, Regazzoli D, et al. 2023 Boston Scientific Corporation or its affiliates. The maximum first principal stresses in calcified lesions were also evaluated by computer simulation using the finite element method.
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