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March 2, 2026CVIR Endovascular0 citationsOpen Access

In vitro evaluation of a new balloon design to treat calcified stenosis

OBOliver Andrew BinkertCBChristoph Andreas BinkertTFThomas Frauenfelder

Key Result

The WAVE balloon with three inflation cycles increased total number of fragments to 112.6 versus 48.6 with standard balloon single inflation and reduced large fragments >9 mm to 7.6 versus 13.2 (p < 0.001).

Key Points

  • To evaluate the effectiveness of a new balloon design in treating calcified stenosis in vitro.
  • Utilized an in vitro model to simulate below-the-knee calcified arteries.
  • Applied a novel balloon design to assess its impact on fragment creation.
  • Analyzed the size and quantity of fragments produced during the procedure.
  • The new balloon design resulted in smaller and more numerous fragments than traditional methods.
  • Findings indicate enhanced potential for improved angioplasty outcomes.

Structured PICO

Does the WAVE concept increase fragmentation and reduce large fragments in an in vitro model of calcified arterial stenosis compared to standard PTA?

P
Population
In vitro model of below-the-knee (BTK) calcified arterial stenosis (3 mm outer diameter, 1.5 mm internal diameter, 7.2 cm length) made of paraffin wax, carnauba wax, and calcium carbonate. Total n=30 experiments.
I
Intervention
WAVE concept: WAVE balloon (3 mm x 80 mm) with three inflation cycles (up to 14 atm) and a slight shift (advanced 3 mm, then retracted 1.5 mm) after each inflation.
C
Comparator
Standard percutaneous transluminal angioplasty (PTA): standard balloon (Bard Ultraverse 0.014, 3 mm x 80 mm) with a single inflation cycle.
O
Outcome
Total number of fragments and the number of large fragments (exceeding 9 mm in length) after angioplasty.surrogate

The WAVE balloon concept with multiple shifted inflations significantly increases fragmentation and reduces large fragments in an in vitro calcified stenosis model, suggesting potential for improved angioplasty outcomes.

Main Result

Effect estimate: p < 0.001 (95% CI 112.6 (95% CI [103.3, 121.9]) fragments vs. 48.6 (95% CI [42.5, 54.7]) fragments; fragments >9mm: 7.6 (95% CI [6.4, 8.8]) vs. 13.2 (95% CI [11.6, 14.8]))

Absolute Event Rate: 112.6% vs 48.6%

p-value: p=<0.001

Limitations

  • The study was conducted in an in vitro model which may not fully replicate in vivo arterial conditions.
  • In vitro lesions modeled ideal cylindrical calcification limited to tunica media; real lesions vary in distribution and composition.
  • Effects of blood flow and biological responses such as luminal gain and vessel compliance were not assessed.
  • Reduced balloon elongation and vessel injury with WAVE balloon was hypothesized but not demonstrated.
  • Further in vivo research is needed to confirm findings.

Abstract

The WAVE concept creates more and smaller fragments in a below-the-knee calcified arterial in vitro model. These findings show promising potential to improve the outcomes of future angioplasty procedures.

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Cite This Study

Binkert et al. (2026) studied Calcified arterial lesions in below-the-knee (BTK) arteries modeled in vitro. WAVE balloon with three inflation cycles and slight balloon shift after each inflation (WAVE concept) vs. Standard angioplasty balloon with single inflation cycle (standard PTA) was evaluated on Total number of fragments and number of fragments exceeding 9 mm in length generated by balloon angioplasty (p < 0.001, 95% CI 112.6 (95% CI [103.3, 121.9]) fragments vs. 48.6 (95% CI [42.5, 54.7]) fragments; fragments >9mm: 7.6 (95% CI [6.4, 8.8]) vs. 13.2 (95% CI [11.6, 14.8]), p=<0.001). The WAVE balloon with three inflation cycles increased total number of fragments to 112.6 versus 48.6 with standard balloon single inflation and reduced large fragments >9 mm to 7.6 versus 13.2 (p < 0.001).

synapsesocial.com/papers/69a52df3f1e85e5c73bf130chttps://doi.org/10.1186/s42155-026-00662-2
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Successful predilation of a resistant, heavily calcified lesion with cutting balloon for coronary stenting: A case report1998 · 30 citations
  2. 2The Impact of Novel Scoring Balloon on Calcified Coronary Lesion as Assessed by Optical Coherence Tomography2026
  3. 3Lithotripsy-assisted TAVR for severe calcific aortic stenosis. Case report2026
  4. 4In Vitro Flow Visualization in Stented Arterial Segments1995 · 7 citations
  5. 5TREATMENT OF CALCIFIC CORONARY STENOSIS WITH SHOCKWAVE: A CASE REPORT2024