A New Dimension in Patient Outcomes
The AngioSculpt Scoring Balloon Catheter is an essential new tool in the treatment of simple to complex lesions, including in-stent restenosis (ISR) and type C lesions. As demonstrated in clinical studies, AngioSculpt was used successfully in treating fibro-calcific, bifurcation and ostial lesions. When used for pre-dilatation prior to stenting, AngioSculpt has been proven to yield a 33%-50% greater luminal gain than either direct stenting or pre-dilatation with a conventional angioplasty balloon catheter.1
- Procedural success rate of 98.5%, with
76% of lesions being types B2/C 2
- Freedom from major adverse cardiac
events 97.5% 2
- Only coronary balloon catheter with specific
indication for treating type C lesions
- Proven effective in complex calcified (35%),
bifurcation (29%) and ostial (13%) lesions 2
- Significantly low dissection rate of
13.6% 2 versus ~30% for POBA5
- No device slippage (even in ISR)
for more accurate placement and
no “geographic miss” 2
- Zero perforations as confirmed by an independent core laboratory 2
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Reduced Dissection Rates
| Severe dissection post-POBA of human coronary artery3 |
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Post-AngioSculpt scoring of porcine ISR4 |
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Technology That Sets a New Standard
- Flexible nitinol scoring element with three rectangular
spiral struts works in tandem with a semi-compliant
balloon to score the target lesion
- Balloon inflation focuses uniform radial forces along
the edges of the nitinol element, scoring the plaque and
resulting in a more precise and predictable outcome
- Low crossing profile (2.7F maximum), 0.014”
system compatible with 6F guiding catheters
- 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 scoring balloon
- Nitinol-enhanced balloon deflation for excellent
rewrap and recross capabilities
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Better Final Post-Stent Dimensions
- Clinical studies show that final stent
luminal dimensions are an important
predictor of better long-term results6
- Pre-dilatation with AngioSculpt yields a 33%–50% greater luminal gain than direct stenting or pre-dilatation with a conventional angioplasty balloon catheter (p<0.001)1
- Pre-dilatation with AngioSculpt resulted
in a post-stent luminal area ≥5.0 mm2 89% of the time, compared to only 74%
with direct stenting or pre-dilatation
with a conventional angioplasty balloon
catheter (p<0.001)1
- AngioSculpt achieved larger post-stent
luminal dimensions than direct stenting or
pre-dilatation with a conventional balloon
regardless of the type of lesion plaque
morphology (i.e., soft, fibrotic, calcific or
mixed plaque)1
More Luminal Gain (p<0.001)1
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Better Final Luminal Dimensions (p<0.001)1
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Note: There was no statistically significant difference between the results for pre-dilatation with a conventional angioplasty balloon and direct stenting.
A Versatile Tool for Treating Bifurcation Lesions
The clinical challenges common in bifurcation
lesions—dissection, slippage and plaque
shifting—can make a lengthy procedure even
longer. AngioSculpt offers physicians an
effective, time-saving tool for treating the
unique challenges of bifurcation lesions.
- No device slippage2 for precise and
predictable treatment of the target lesion
- Uniform, radial, scoring forces beneficial for
treating elastin-rich ostial lesions
- Low dissection rates2 may lead to reduced
need for “bail-out” stenting
- Electropolished nitinol edges provide a
margin of safety in complex anatomy
- Better final luminal dimensions in the main
branch post-stenting1
Pre-treatment: AngioSculpt placed at side branch in bifurcation lesion
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Post-treatment: AngioSculpt used as stand-alone treatment in side branch and pre-dilatation tool in main branch
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References:
- Costa JR, Leon MB, Mintz GS, Mehran R, Teirstein P, Sano K, Kimura M, Tanaka K, Liu X, Lui J, Na Y, Castellanos C, Biro S, Dani L, Rinker J, Dangas G, Stone GW, Moses JW, Carlier SG: Impact of Different Pre-dilatation Strategies on Stent Expansion: An Intravascular Ultrasound Study. Circulation, October 2006; Vol. 114, No 18, Supplement II: 732.
- Mooney M, Teirstein P, Moses J, Turco M, Reisman M, Waksman R, Saucedo J, Mauri L, Lee D, Gershony G, Mehran R, Carlier S, Lansky A, Leon M: Final Results from the U.S. Multi-Center Trial of the AngioSculpt Scoring Balloon Catheter for the Treatment of Complex Coronary Artery Lesions. American Journal of Cardiology, October 2006; Vol. 98, Issue 8, Supplement: 121M.
- Holmes DR Jr, Mathew V, eds. Atlas of Interventional Cardiology. 2nd ed. Philadelphia, Pa: Current
Medicine Group; 2003.
- 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.
- Vlietstra RE, Holmes DR Jr,
eds. Coronary Balloon Angioplasty. Boston, Mass: Blackwell Scientific Publications; 1994:399-451.
- 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 Cardiol. 2004;43:1959-1963.
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.
Last Updated: November 2, 2007
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