AngioScore    
  AngioSculpt Scoring Balloon Catheter  
AngioSculpt PTA - Scoring Balloon Catheter
Peak Performance in Peripheral Angioplasty

The introduction of the AngioSculpt Scoring Balloon Catheter significantly alters the landscape for treating peripheral artery disease (PAD), offering the peak performance that only an innovative clinical solution can provide. Designed to address a wide range of peripheral lesions—including the most challenging, complex types—the AngioSculpt Scoring Balloon Catheter provides the versatility and effectiveness required of a new technology together with the simplicity, deliverability and reduced procedure time of a high-performance balloon catheter.
 
A New Measure of Success
  • Successful deployment in 98.8% of lesions1
  • Procedural success without adjunctive stenting in 84.9% of lesions1
  • Proven effective in complex calcified lesions (67.4%), bifurcation (25.6%), and ostial (15.1%) lesions1
  • Significantly low dissection rate of 12.8% vs. ~30% for POBA2 in a recent clinical study1
  • Efficacious in treating CLI with 82.5% of patients Rutherford Class ≥ 41

Pre-AngioSculpt

Pre-AngioSculpt - Tibioperoneal lesion with calcifi cation and 90% stenosis
Figure 1. Tibioperoneal lesion with calcification and 90% stenosis
  

Post-AngioSculpt

Post-AngioSculpt - 'Stent-like' result after treatment with 3.5 x 20 mm AngioSculpt with one inflation at 8 atm
Figure 2. “Stent-like” result after treatment with 3.5 x 20 mm AngioSculpt with one inflation at 8 atm
 

A Uniform Approach to Dilatation

  • A flexible, nitinol scoring element with three or four rectangular spiral struts works in tandem with a semi-compliant balloon to score the target lesion1
  • Balloon inflation focuses uniform radial forces along the edges of the nitinol element, scoring the plaque and resulting in a more precise and predictable outcome1
  • No significant device slippage means accurate placement (no “geographic miss”)1
  • Reduced dissection rates1 mean better final luminal dimensions (See Figures 3 and 4)
  • Zero perforations1

Reduced Dissection Rates

Dissection Rates

Figure 3. Severe dissection post-POBA of human coronary artery3

  

Figure 4. Post-AngioSculpt scoring of porcine ISR4

A Profile of Predicatability

  • Low-profile, 0.014” or 0.018" (4.0mm/5.0mm diameter) OTW system
  • Compatible with 5F or 6F (4.0mm/5.0mm diameter) sheaths
  • Semi-compliant balloon material allows the physician to tailor the device size to the vessel (2–20 atm) depending on the size of the balloon
  • Two radiopaque markers indicate the working ends of the catheter
  • Nitinol-enhanced balloon deflation for excellent rewrap and recross capabilities
AngioSculpt Scoring Element

Electropolished struts provide an extra margin of safety, resulting in zero perforations and no slippage.
 

References:

  1. Scheinert D, Graziani L, Peeters P, Bosiers M, O’Sullivan G, Sultan S, Gray W, Laird J, Turco M, Dave R, Das T, Piemonte T, Khanna P, Gershony G: Results From the Multi-Center Registry of the Novel AngioSculpt Scoring Balloon Catheter for the Treatment of Infra-Popliteal Disease. Cardiovascular Revascularization Medicine, April-June 2007; Vol. 8, Issue 2: 147.
  2. Vlietstra RE, Holmes DR Jr, eds. Coronary Balloon Angioplasty. Boston, Mass: Blackwell Scientific Publications; 1994:399-451.
  3. Holmes DR Jr, Mathew V, eds. Atlas of Interventional Cardiology. 2nd ed. Philadelphia, Pa: Current Medicine Group; 2003.
  4. AngioSculpt Study Report: AngioSculpt efficacy and safety study in a porcine model of coronary artery in-stent restenosis (ISR). March 23, 2003. On file at AngioScore, Inc.
 

Caution: Federal law (USA) restricts the AngioSculpt Scoring Balloon Catheter to sale by or on the order of a physician.
CE Mark Granted for Coronary and Peripheral Applications.

WS-1000-0001 Rev B 01/09