SCORING BALLOON CATHETER WITH NITINOL SCORING ELEMENT
INDICATED FOR CORONARY ARTERY STENOSIS, INCLUDING IN-STENT RESTENOSIS
The AngioSculpt PTCA scoring balloon catheter is an essential tool in the treatment of a wide range of coronary lesions, including in-stent restenosis (ISR) and type C lesions.
- A new dimension in plaque modification
- Advanced technology delivers big results
- Pre-dilation results in larger luminal gain than direct stenting or conventional balloon angioplasty
- Rectangular scoring edges lock the device in place.
- No significant device slippage or “watermelon seeding”, even in ISR.1
Enhanced mechanical advantage
- The leading edges are designed to drive outward expansion with up to approximately 15 to 25 times the force of conventional balloons.2
- Helical nitinol scoring element creates a large initial luminal expansion for stent implantation.3
- Post scoring, outward forces are designed to be equivalent to that of a conventional balloon.
- Low dissection rate of 13.6%.1
- Large working range (2 atm up to 20 atm) allows physician to tailor device to vessel size.
- Nitinol-enhanced balloon deflation for excellent rewrap and re-cross capabilities.
- Electropolished, helical scoring element safely scores lesion circumferentially.4
- Rectangular edges provide a predictable dilatation resulting in low dissection rates and minimal device slippage.1
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
- Pre-dilatation with AngioSculpt yielded 33-50% greater luminal gain than direct stenting or pre-dilatation with a conventional angioplasty balloon.3
- 89% of the vessels predilated with AngioSculpt had a final stent area of ≥ 5.0 mm² compared to 74% for direct stenting or pre-dilatation with a conventional balloon.3
- 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).3
AngioSculpt PTCA Scoring Balloon
- Prospective, randomized, active, controlled multi-center clinical trial to compare the anti-restenotic efficacy of scoring balloon (SCB) pre-dilation before drug-coated balloon (DCB) therapy versus standard balloon pre-dilation (Plain Old Balloon Angioplasty, POBA) before DCB therapy in patients with limus-eluting stent (LES) restenosis. Baseline characteristics were not significantly different in the two groups.
- Number of patients (n): 252
- Primary endpoint: Percent diameter stenosis (%DS) at 6-8 months
|AngioSculpt PTCA Balloon Catheter|
|Recommended guide wire
||Uncoated for non-slip|
|Nitinol scoring elements
|Profile of scoring elements
|Guiding catheter||6 F (0.068"/1.73 mm)
|Crossing profile||~2.7 F|
|Balloon Diameter x Length (mm)|
|Rated Burst Pressure||atm6||20||20||18||16|
1 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.
2 AngioSculpt Test Plan ST-1197 (2008), on file at AngioScore, Inc.
3 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.
4 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.
5 Sonoda 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.
6 1 atm = 1.013 bar