MODERN PCI - PREP

Clear-cut control in complex lesions.

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

Clinically proven safety

WOLVERINE™ Cutting Balloon product image

WOLVERINE’s unique atherotome design delivers micro-incisions which deliver precise, predictable, 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. With over 30 years of clinical evidence, the WOLVERINE Coronary Cutting Balloon is proven to deliver unmatched versatility and clinically proven safety.

Clinical Evidence in Calcified CAD Lesions

COPS TRIAL²

In the COPS Study², the WOLVERINE device demonstrated a safety profile similar to POBA, with no significant differences in procedural complications or major adverse cardiac events (MACE) after one year.

Kinnaird et. al Study³

The Kinnaird et. Al Study suggested that Cutting Ballons may be associated with a lower risk of perforation during PCI procedures. The odds of perforation were significantly lower in cases with Cutting Balloon use (OR 0.62, 95% CI 0.43-0.89, p = 0.01).

Matsukawa et. al Clinical Study⁴

The Matsukawa et. al Clinical Study data suggest that Cutting Balloon is more effective for plaque modification in cases of severe calcified lesions than other scoring balloons.

Explore these studies further

See how it works

Watch how WOLVERINE's compact design and innovative mechanism of action empower seamless navigation and optimal prep in challenging anatomies.

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 action² ⁵

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

Microincisions

Minimize elastic recoil for more even expansion lines.

Anchoring

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

Focused force

Creates powerful but precise longitudinal fractures in calcific lesions.

View WOLVERINE device specifications

3x the stress, focused at the atherotomes

WOLVERINE vs. NC balloon⁶

The WOLVERINE Cutting Balloon's microsurgical atherotomes concentrate stress in three to four distinct areas, creating controlled and predictable calcium fractures.

This contrasts with the NC Balloon, which exhibits a much lower stress distribution when inflated to the same pressure of 12 ATM.⁶

Even at 20 ATM, the NC Balloon demonstrates lower and unfocused stress compared to WOLVERINE, leading to uncontrolled fractures.⁶

Controlled, predictable calcium fractures

in eccentric calcium

in concentric calcium

Lower arc of calcium = lower Shockwave™ efficacy.⁷

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.⁷

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

Controlled calcium fractures

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

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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. Kinnaird T, et al. Circ Cardiovasc Interv. 2016;9(8).

4. Matsukaw a, et al, Cardiovascular Intervention and Therapeutics (2019) 34:325 - 334.

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

* 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.

WOLVERINE Indications, Safety and Warnings