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Orbital Treatment in a High Volume Clinical Practice

Single-Center Physician Initiated Study Confirms Modifying Non-Compliant Plaque with Orbital Atherectomy Delivers Durable Long-Term Results

 

Study Overview

Patient with PAD underwent primary intervention with Predator 360 PAD System, followed by low-pressure balloon inflation pressures, if necessary.

 

Procedural Parameters

Procedural Data N=46, n=57
  Average (range)
Number of OAS devices used per lesion 0.89 (1-2)
  • Multiple lesions treated with one device
Adjunctive Therapy m/n (%)
Adjunctive therapy performed 47/57 (82.5)
  • PTA
  • 46/47 (97.9)
  • PTA Cryo
  • 1/47 (2.1)
  • Bailout stent placement
  • 0/47 (0)

 

Procedural complications n/N (%)
Dissections 1/57 (1.8)
Perforation 0/0 (0)
Perforation 0/0 (0)
Slow flow 0/0 (0)
Closure 0/0 (0)
Spasm 1/57 (1.8)
Embolism 0/0 (0)
Thrombus 0/0 (0)
Total procedural complications rate 2/57 (3.5)

 

Key Findings

  • Durable long-term results can be achieved out to 12-months with orbital technology1, 2
    • 10.9% reintervention rates at one year.

 

Conclusions

  • The use of orbital technology modifies lesion compliance in resistant plaques.
    • Demonstrated by successful index procedure outcomes that utilized only low-pressure and short duration post-orbital balloon inflations.
  • Bail-out stenting was eliminated in this challenging patient population.
  • Use of orbital technology resulted in durable long-term results as demonstrated by low reintervention rate at 12 months.

 

Click here to access a PDF of the abstract

 

  1. Makam P. Use of orbital treatment in a high volume clinical practice modifies non-compliant plaque to deliver durable long-term results. Poster Abstract. VIVA 2011.
  2. Weinstock B. OASIS LT. Post Abstract. TCT 2009.

 

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