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 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 ³

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 balloon⁴

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.⁴

Even at 20 ATM, the NC Balloon demonstrates lower and unfocused stress compared to WOLVERINE, leading to uncontrolled fractures.⁴

Controlled, predictable calcium fractures

in eccentric calcium

in concentric calcium

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

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.

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

7. 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.