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WOLVERINE™ Coronary Cutting Balloon™
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- Overview
- Clinical data
- Technical specifications
- Ordering information
- Training
- Resources
Your go-to device for complex lesion prep
The WOLVERINE Coronary Cutting Balloon delivers unmatched clinical versatility, backed by over 3 decades of clinical evidence.
How it works
WOLVERINE's unique atherotome design creates micro-incisions to deliver precise, predictable and controlled lesion modification. As a result, it can fracture concentric and eccentric calcium, change fibrotic lesion compliance1, avoid plaque shift in ostial and bifurcation, and reduce restenosis in small vessels.2
Why choose WOLVERINE?
Unmatched versatility for maximum lumen gain with minimal risk
Adequate vessel prep is essential for more controlled vessel expansion, less vessel trauma, and improved drug uptake or stent apposition.3
Unmatched versatility with a proven mechanism of action⁴ ⁵
Superior outcomes at lower focused pressures
3x the stress, focused at the atherotomes for controlled cracking
*Results of computer models are not predictive of clinical performance. Clinical results may vary.
WOLVERINE Cutting Balloon concentrates pressure at microsurgical atherotomes, creating controlled predictable calcium fractures.
- This contrasts with the NC Balloon, which exhibits a much lower stress distribution when inflated to the same pressure of 12 ATM6
- Even at 20 ATM, the NC Balloon demonstrates lower and unfocused stress compared to WOLVERINE, leading to uncontrolled fractures6
Protecting from perforation during PCI
WOLVERINE’s unique mechanism of action is associated with decreased risk of perforation.2
Discover the Modern PCI approach
See the vessel
Assess plaque type and severity using the latest imaging and physiology technology. Eliminate guesswork and make clearer treatment decisions.
Prep the vessel
Successful outcomes start with proper lesion assessment and vessel preparation. Achieve optimal lumen gain with our cutting balloon and rotational atherectomy tools.
Treat the vessel
With our innovative stent portfolio and coronary drug-coated balloon technology, you have access to market-leading therapies that will ensure you are able to improve long-term patient outcomes.
Calcium Lesion Modification Strategy7
Sharpen your approach to calcium modification with a simplified and highly effective approach to modifying calcific lesions.
30+ years of clinical evidence
WOLVERINE vs. POBA
WOLVERINE is the only device clinically proven to provide superior MSA at the calcium site compared to POBA with no significant difference in procedural complications or 1-year MACE in a randomized clinical trial.
ROTACut: Rotational atherectomy and cutting balloon combination strategy
Operators achieved higher acute lumen gain in severely calcified lesions with combination of rotational atherectomy and modified balloons as compared to atherectomy or modified balloon alone.
Cutting Balloon: Protection from Perforation
The comprehensive analysis of over half a million PCI procedures in England and Wales performed 2006-2013 compared perforation rates in cases with and without Cutting Balloon use. This study suggested that Cutting Balloons may be associated with a lower risk of perforation during PCI procedures (OR 0.62, 95% CI 0.43–0.89, P = 0.01).2
Reduced balloon slippage and need for additional stenting
The RESCUT study9 showed Wolverine use in ISR cases provided a reduction in balloon slippage and the need for additional stenting compared to POBA. The cutting balloon’s anchoring ability minimizes slippage in even ostial and bifurcation lesions.
Modern PCI clinical data
Discover more clinical data for intravascular ultrasound (IVUS), FFR, and drug-eluting therapies.
Technical specifications
1. Bumper Tip | 2. Acrylated urethane atherotome adhesive | 3. Atherotomes | 4. Z-Glide™ Hydrophilic Coating | 5. Midshaft | 6. Proximal Marks | 7. Hypotube/Corewire Assembly | 8. Manifold
Atherotome advantage
Discover a new level of control. WOLVERINE is the only balloon with atherotomes that anchor to tissue and precisely dilate noncompliant lesions at low pressures, with low risk of vessel trauma. By creating controlled microincisions, WOLVERINE safely minimizes elastic recoil in resistant lesions.
From concept to creation
Follow along the journey of our R&D process and hear from the engineers who developed the WOLVERINE Coronary Cutting Balloon. Discover what makes our unique angioplasty device empower physicians to navigate challenging anatomies for optimal prep.
Download the WOLVERINE Expansion Chart to view WOLVERINE inflation and sizing specifications.
Modern PCI
Access the broadest portfolio of dependable, sophisticated PCI devices to see, prep, and treat coronary artery disease.
Ordering information
| Balloon Diameter (mm) | 6 mm Blade Length | 10 mm Blade Length | 15 mm Blade Length |
|---|---|---|---|
| 2.00 | H749 3940106200 0 | H74939 40110200 0 | H74939 40115200 0 |
| 2.25 | H749 3940106225 0 | H74939 40110225 0 | H74939 40115225 0 |
| 2.50 | H749 3940106250 0 | H74939 40110250 0 | H74939 40115250 0 |
| 2.75 | H749 3940106275 0 | H74939 40110275 0 | H74939 40115275 0 |
| 3.00 | H749 3940106300 0 | H74939 40110300 0 | H74939 40115300 0 |
| 3.25 | H749 3940106325 0 | H74939 40110325 0 | H74939 40115325 0 |
| 3.50 | H749 3940106350 0 | H74939 40110350 0 | H74939 40115350 0 |
| 3.75 | H749 3940106375 0 | H74939 40110375 0 | H74939 40115375 0 |
| 4.00 | H749 3940106400 0 | H74939 40110400 0 | H74939 40115400 0 |
The most complete PCI portfolio in the industry
Access the broadest portfolio of dependable, sophisticated PCI devices so you have access to the right tools to see, prepare, and treat coronary artery disease.
Education for WOLVERINE Cutting Balloon
See how experts use IVUS to assess key calcium morphologies and leverage the IVUS 123 algorithm to guide appropriate calcium modification strategies, stent optimization, and post-stent assessment.
Online medical training and education courses
The EDUCARE online platform makes healthcare education and training more relevant, more comprehensive, more personal, and more accessible. Register to access a library of procedural videos, case studies, training resources, and events.
Resources
References:
1. Riley RF, et al. J Soc Cardiovasc Angiogr. Interv. 2023;3(2):101259.
2. Kinnaird, Tim et al. Circulation. Cardiovascular interventions vol. 9,8 (2016): e003449.
3. Matsukawa R, et al. Cardiovasc Interv Ther. 2019;34(4):325-334.
4. COPS Trial: Cutting balloon to Optimize Predilatation for Stenting. Presented at TCT 2022 by Antonio Mangieri, MD on behalf of Antonia Colombo and the COPS investigators.
5. Ishihara et al.; Cardio. Intervention and Therapeutics 2021;36:198-207.
6. Xiaodong Zhu et al.;Circ Rep 2021; 3: 1 – 8 doi: 10.1253/circrep.CR-20-0070.
7. Adapted from Calcium Algorithm presented by Simon Walsh, MD, Boston.
8. Allali A, Toelg R, Abdel-Wahab M, et al. Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study. Catheter Cardiovasc Interv. 2022;100(6):979-989.
9. Albiero R, Silber S, Di Mario C, et al. Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT). J Am Coll Cardiol. 2004;43(6):943-949. doi:10.1016/j.jacc.2003.09.054