AngioSculpt PTCA

Vascular Intervention // Coronary
Scoring Balloon Catheter

AngioSculpt PTCA


     Advanced scoring balloon technology

     Precision, power and predictable results

     Larger luminal gain




Advanced scoring balloon technology

Electropolished, helical scoring element safely scores lesion circumferentially.1

Rectangular edges provide a predictable dilatation resulting in low dissection rates and minimal device slippage.2

Nitinol-enhanced balloon deflation for excellent rewrap and recross capabilities.

Large working range (2–20 atm) allows device to be tailored to vessel size.






Precision, power and predictable results





Larger luminal gain

Post-stent luminal area is an important predictor of long-term outcome. Studies have shown that greater acute luminal gain is associated with better long-term results.5

The AngioSculpt group exhibited greater stent expansion than both POBA and direct stent groups, regardless of lesion type or plaque morphology (e.g. soft, fibrotic, calcific or mixed plaque).4

 

 

 


More luminal gain (p = 0.004)4




Pre-dilatation with AngioSculpt yielded 33% - 50% greater luminal gain than direct stenting or pre-dilatation with a conventional angioplasty balloon.4

 

 

 

 

 

 


Better final luminal dimensions (p < 0.001)4





89% of the vessels predilated with AngioSculpt had final stent area ≥ 5.0 mm2 compared to 74% for direct stenting or pre-dilatation with a conventional balloon.4



Note: There was no statistically significant difference between the results for pre-dilatation with a conventional angioplasty balloon and direct stenting.

 

 

 

 

 

 

 


 

 

 

 

AngioSculpt PTCA

 


Indicated for the treatment of a hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion.

 

Media

AngioSculpt PTCA Scoring Balloon


Technical Data

AngioSculpt PTCA Balloon Catheter
Catheter type
Rx
Recommended guide wire
0.014"
Usable length
137 cm
Balloon coating
Uncoated for non-slip
Balloon markers
2 markers
Nitinol scoring elements
3 ea.
Profile of scoring elements
~0.005"
Guiding catheter 6 F (0.068"/1.73 mm)
Crossing profile ~2.7 F

Compliance Chart

Balloon Diameter x Length (mm)
    ø 2.0 x
10-20
ø 2.5 x
10-20
ø 3.0 x
10-20
ø 3.5 x
10-20
Nominal Pressure (NP) atm* 8 8 8 8
  ø (mm) 2.01 2.49 3.01 3.51
Rated Burst Pressure (RBP) atm* 20 20 18 16
  ø (mm) 2.37 2.95 3.5 3.86
                                      *1 atm = 1.013 bar

Ordering Information

Balloon ø (mm) Catheter length 137 cm (balloon length mm)
101520
2.0 360217 360218 360220
2.5 360221 360222 360225
3.0 360227 360228 360229
3.5 360230 360231 360233

Contact

contact
Country/Region

1 Fonseca A, Costa JR, Abizaid A, et al. Intravascular ultrasound assessment of the novel AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008; 20: 21-27;

2 Mooney M, Teirstein P, Moses J, et al. Final results from the U.S. multi-center trial of the AngioSculpt Scoring Balloon Catheter for the treatment of complex coronary artery lesions. Am J Cardiol. 2006; 98(suppl 8): 121M;

3 AngioSculpt Test Plan ST-1197 (2008), on file at Spectranetics Corp.;

4 Costa JR, Mintz GS, Carlier SG, et al. Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon. Am J Cardiol. 2007; 100: 812-817;

5Sonoda S, Morino Y, Ako J, et al. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the SIRIUS trial. J Am Coll Cardio. 2004; 43: 1959-1963.


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