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WOLVERINE™ Cutting Balloon

MODERN PCI - PREP

Clear-cut control in complex lesions.

Unlock the hidden potential of the WOLVERINE™ Coronary Cutting Balloon™.

Your go-to device for complex lesion prep

WOLVERINE™ Cutting Balloon product image

 

Fracture concentric and eccentric calcium, change fibrotic lesion compliance¹, avoid plaque shift in ostial and bifurcation, and reduce restenosis in small vessels. With over 30 years of clinical evidence, the WOLVERINE Coronary Cutting Balloon is proven to deliver unmatched clinical versatility.

See it to believe it

This 1 min video demonstrates how the WOLVERINE Coronary Cutting Balloon creates controlled calcium fractures for predictable results.


Fixed, microsurgical atherotomes

Discover a new level of control. WOLVERINE is the only balloon with atherotomes that can anchor to tissue and precisely dilate noncompliant lesions at low pressures, and with low risk of vessel trauma. By creating controlled microincisions, WOLVERINE safely minimizes elastic recoil in resistant lesions. 

A proven mechanism of action³

Discover the key benefits of WOLVERINE's intentionally designed microsurgical atherotomes:

microincisions

Microincisions

Minimize elastic recoil for more even expansion lines.

anchoring

Anchoring

Secures device in place to reduce the risk of balloon and plaque shift.

target icon

Focused force

Creates powerful but precise longitudinal fractures in calcific lesions.

3x the stress, focused at the atherotomes

WOLVERINE vs. NC balloon⁴

WOLVERINE Demonstrates Superior Tensile Stress Control vs. NC Balloon

Cutting Balloon vs. NC Balloon

The Wolverine coronary cutting balloon's added microsurgical atherotomes focus stress in three distinct areas to create controlled, predictable calcium fractures.

This is in contrast to the NC Balloon, which shows a much lower stress distribution when used at the same 12 ATM inflation pressure. Even at 20 ATM, the stress is still much lower and unfocused, leading to uncontrolled fractures.⁴


Controlled, predictable calcium fractures

in eccentric calcium

eccentric lesions

in concentric calcium

concentric lesions
eccentric arrow

Lower arc of calcium = lower Shockwave™ efficacy.⁵

IVL doesn't always cut it

Device orientation directly impacts the probability of effective fractures. 

When it comes to prepping eccentric plaque, IVL often falls short. The DISRUPT CAD III OCT Sub study showed that reduced arc of calcium directly corresponds to reduced Shockwave fracture effectiveness.⁵ 

Vessels

Sharpen your approach to calcium modification with the Calcium Lesion Modification Strategy.

Clinical Evidence in Calcified CAD Lesions

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.

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.

In >180-degree arc calcium, WOLVERINE plus rotational atherectomy increased mean minimum stent CSA, with lower rates of TVR and MACE.

1. Bertrand et al. Catheter Cardio Diag 1997; 41:179-184.​

2. 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.

3. Ishihara et al.; Cardio. Intervention and Therapeutics (2021) 36:198-207.

4. Xiaodong Zhu et al.;Circ Rep 2021; 3: 1 – 8 doi: 10.1253/circrep.CR-20-0070.  

5. DISRUPT CAD IIII data provided by Catholic Health CRF Clinical Trials Center Data.

6. Bouisset et al. EuroIntervention 2020 Apr 7;EIJ-D-19-01129.

7. Praz F, Di Mario C, Dudek D, et al. EuroIntervention. 2023;18(12):1390-1397.

8. Li, Qiyong, et al. MBC cardiovascular disorders 16.1 (2016): 1-9.

* Results of computer models are not predictive of clinical performance.  Clinical results may vary.

Illustrations shown for educational purpose only. Not indicative of actual clinical outcome.

CAUTION: The law restricts these devices to sale by or on the order of a physician.