See clearly. Treat optimally.

Philips coronary solutions give you the visualization needed to quickly and precisely assess complex PCI challenges so you can treat optimally with Philips therapeutic solutions.

Complex PCI cases are becoming more common, leading to an increased risk of adverse events.¹

Clear procedural guidance and optimal vessel preparation can help you achieve better outcomes. Explore the different challenges seen in complex PCI cases and how Philips’ specialty tools can help you.

In-stent restenosis (ISR)

Real-world incidence rates of in-stent restenosis (ISR) account for 12% of PCI.²Each patient requires a customized treatment strategy based on the extent and mechanism of their restenosis, requiring flexibility in your toolkit and approach.^3,4

Rates of restenosis at follow up²

Clinical challenges

Target lesion revascularization rates remain an issue even today when using multiple overlapping stents.

– 2^ndstent 12-16% at 12 months and 33% at 3-5 years⁵

– 3^rd stent 25% at 6 months⁵

Angiography alone cannot provide the information necessary to fully understand the mechanism and extent of ISR.³

– Difficult to identify under-expansion or mal-apposition

– Challenging to determine if it is geographical miss or under-sizing

– Inability to discern between neointimal hyperplasia or neo-atherosclerosis

Traditional mechanical tools have limitations for treating ISR.

– Mechanical tools, from angioplasty to rotational or orbital atherectomy, are largely ineffective in restenotic lesions.⁶

– The unique soft, aqueous morphology of neointimal hyperplasia tissue presents a challenge to mechanical intervention.⁶

Risk of restenosis

Growing with each layer of stent⁵

Angiography cannot determine the mechanism of ISR

Clinical challenges

Target lesion revascularization rates remain an issue even today when using multiple overlapping stents.

– 2^ndstent 12-16% at 12 months and 33% at 3-5 years⁵

– 3^rd stent 25% at 6 months⁵

Risk of restenosis

Growing with each layer of stent⁵

Angiography alone cannot provide the information necessary to fully understand the mechanism and extent of ISR.³

– Difficult to identify under-expansion or mal-apposition

– Challenging to determine if it is geographical miss or under-sizing

– Inability to discern between neointimal hyperplasia or neo-atherosclerosis

Traditional mechanical tools have limitations for treating ISR.

– Mechanical tools, from angioplasty to rotational or orbital atherectomy, are largely ineffective in restenotic lesions.⁶

– The unique soft, aqueous morphology of neointimal hyperplasia tissue presents a challenge to mechanical intervention.⁶

Angiography cannot determine the mechanism of ISR

Philips is here to help you achieve better outcomes in ISR cases

Philips IVUS and IVUS Co-registration on IntraSight:

Help determine the mechanism of stent restenosis or stent thrombosis.
Allow optimization of treatment strategy and device utilization.
Help confirm pre and post therapy results.

ELCA laser atherectomy catheter:

Modifies plaque, even behind struts, to facilitate stent expansion
Ablates lesion material.
Maximizes lumen for additional stent expansion and placement.

AngioSculpt PTCA scoring balloon catheter:

Resists slipping within the vessel.
Provides improved luminal gain.⁸
Increases focal pressure to reset stents, minimizing the need for future additional stents.

Comparative luminal gain⁸

Philips IVUS and CoreVision advanced imaging solution:

Help determine the mechanism of stent restenosis or stent thrombosis.
Allow optimization of treatment strategy and device utilization.
Help confirm pre and post therapy results.

ELCA laser atherectomy catheter:

Modifies plaque, even behind struts, to facilitate stent expansion
Ablates lesion material.
Maximizes lumen for additional stent expansion and placement.

AngioSculpt PTCA scoring balloon catheter:

Resists slipping within the vessel.
Provides improved luminal gain.⁸
Increases focal pressure to reset stents, minimizing the need for future additional stents.

Comparative luminal gain⁸

Hear how Dr. Jost used laser atherectomy to change in his patient's outcome

Hear Dr. Kalra’s algorithm for dealing with under expanded stents

Educational resources

ISR algorithm

ISR brochure

ISR case review – Allen Jeremias, MD, MSc

ELCA case review – Anjan Gupta, MD and Romas Kirvaitis, MD

JIC article: Coronary In-Stent Restenosis: An Algorithmic Approach to Diagnosis and Treatment

Ostial and bifurcation lesions

Ostial and bifurcation lesions represent nearly 40% of complex PCI’s.⁹

Philips image on file

Clinical challenges

Ostial and bifurcation lesions are associated with higher rates of adverse cardiac events.^10,11
Angiographic details of ostial and bifurcation lesions are often obscured due to angulation and overlap.
Identifying the proper treatment strategy is difficult with traditional angiography.
Risk of plaque or carina shift could cut off blood supply

Philips is here to help you achieve better outcomes in ostial and bifurcation cases:

Philips IVUS and IVUS Co-registration on IntraSight*:

Study data reported IVUS guidance was associated with an 89% reduction in all-cause mortality in bifurcation lesions and 50% reduction in the composite of cardiovascular death, MI, or TLR in ostial lesions.¹⁰
Assist in identifying the true ostium, plaque distribution, vessel sizes and lesion length.
Aid in therapy delivery by avoiding geographic miss or extending stent struts into the ostium.
Co-registration allows you to more easily correlate plaque and treatment locations to the angiogram.

AngioSculpt PTCA scoring balloon catheter:

The only coronary specialty balloon indicated for type C lesions, including ostial lesions.
Helps you apply maximum dilation force with less risk of dissection compared to other PTCA balloons.¹³
Avoids slippage during dilation by locking in place with its unique rectangular nitinol scoring elements.

ELCA laser atherectomy catheter:

The only coronary atherectomy device with an ostial lesion indication.
Vaporizes multiple plaque morphologies at the ostium to avoid plaque shift.
Delivers over any wire and can be used with multiple wires in place.

Educational resources

ELCA case review of CFX subtotal occlusion – Antonis Pratsos, MD

ELCA case review – Jack Casas, MD, FACC

Images provided courtesy of Allen Jeremias, MD, MSc

Image illustrates SyncVision's Device Detection software which enables easy visualization of therapy delivery.

AngioSculpt PTCA scoring balloon catheter:

The only coronary specialty balloon indicated for type C lesions, including ostial lesions.
Helps you apply maximum dilation force with less risk of dissection compared to other PTCA balloons.¹³
Avoids slippage during dilation by locking in place with its unique rectangular nitinol scoring elements.

Images provided courtesy of Allen Jeremias, MD, MSc

Image illustrates CoreVision's Device Detection software which enables easy visualization of therapy delivery.

ELCA laser atherectomy catheter:

The only coronary atherectomy device with an ostial lesion indication.
Vaporizes multiple plaque morphologies at the ostium to avoid plaque shift.
Delivers over any wire and can be used with multiple wires in place.

Educational resources

ELCA case review of CFX subtotal occlusion – Antonis Pratsos, MD

ELCA case review – Jack Casas, MD, FACC

Chronic total occulsions (CTOs)

Incidence increases with age, yet older patients are less likely to have PCI attempted.¹⁴ Furthermore, 18% of PCIs have a CTO, but less than 5% are being treated.¹⁵

CTO of the RCA - image provided by Craig Thompson, MD

Clinical challenges

CTOs are difficult to wire and re-canalize, resulting in lengthy procedures and potentially higher radiation exposure and contrast use.
CTOs are often associated with lower procedural success rates, increased restenosis and re-occlusion compared with non-CTO procedures.^16,17
Hard proximal caps often prevent therapy from being delivered.

Philips is here to help you achieve better outcomes in CTO cases

Philips IVUS and IVUS Co-registration on IntraSight*:

Help optimize vessel sizing for treatment strategy and to confirm your result after successful re-canalization.
Provide enhanced and stabilized angiographic views to optimize therapy delivery.
Study data reported when IVUS was used to help guide treatment there was significantly lower 12 month MACE and cardiac death rate vs angiography alone.¹⁸

IVUS-guided vs. angiography-guided outcomes¹⁸

AngioSculpt PTCA scoring balloon catheter

The only coronary specialty balloon indicated for type C lesions.
Provides the power necessary to maximize lumen diameter once a wire crosses.
Delivers 15-25x’s the focal force of a traditional balloon.¹⁹

ELCA laser atherectomy catheter:

The only coronary atherectomy device with a CTO indication.
Enables crossing 94% of lesions which previously failed balloon angioplasty.²⁰
Modifies the plaque, creates a channel, and enables the delivery of other therapeutic devices.
Delivers over any wire already across a CTO, unlike other atherectomy devices.

Educational resources

CTO brochure

ELCA case review CTO in LAD – Rakesh Bhan, MD

ELCA case review LAD – Gaurav Aggarwala, MD

ELCA case review Circumflex – Antonis Pratsos, MD

ELCA Success and safety rates

Calcified lesions

An increasing number of patients with calcified coronary artery lesions are being referred for PCI. A recent pooled analysis reported moderate to severe target lesion calcification in 32% of patients.²¹

Digital grayscale EEP plaque with calcium

Philips image on file

Clinical challenges

Angiographic measures of procedural success, such as acute gain and diameter stenosis, are often worse in calcified lesions.^22,23,24
Stent under-expansion, asymmetric expansion, and mal-apposition are frequently observed in heavily calcified lesions.^25,26,27
Noncompliant calcified plaques often require high-pressure balloon dilation, increasing the risk for adverse events such as coronary dissection and thrombosis.^28,22,23

Philips image on file

Philips is here to help you achieve better outcomes in calcified lesion cases

Philips IVUS and IVUS Co-registration on IntraSight*:

Help detect coronary artery calcification better than coronary angiography, which has a low-moderate sensitivity.^29,30,31
Help quantify and distinguish the calcium burden, which may impact your treatment strategy.

AngioSculpt PTCA scoring balloon catheter:

The only coronary specialty balloon indicated for type C lesions.
Delivers 15-25x’s the focal force of a traditional balloon with its nitinol scoring element.¹⁹
Improves vessel compliance by scoring plaque, enabling greater lesion expansion and reducing recoil while preventing uncontrolled dissections.

ELCA laser atherectomy catheter:

The only coronary atherectomy device with a moderate calcium indication.
Demonstrates procedural effectiveness in crossing and modifying calcified lesions previously resistant to traditional balloon techniques.¹⁸
Adjustable high frequency settings to modify plaque and can be facilitated with any wire.

Educational resources

ELCA case study: Long, calcified CTO of cicumflex – Antonis Pratsos, MD

Bilodeau study sheet

LEONARDO clinical abstract

Recanalization of LAD - Robert Lee Jobe, MD

Diffuse disease

Approximately 20% of the coronary lesions treated today are greater than 20mm in length.^32,33

Image courtesy of Alphonse Ambrosia, DO

Clinical challenges

Diffuse or long lesions are associated with decreased procedural success and are associated with higher rates of restenosis.³⁴

– Stent length is an independent predictor of in-stent restenosis and thrombosis³⁵

– Stenting long segments with multiple and or overlapping stents may lead to injury to the vessel wall integrity³⁶

Angiography alone may not be able to identify the critical lesion.

– Diffuse CAD may be underestimated by evaluation with coronary angiography³⁷

– Determining reference vessel sizing can be challenging when the vessel is diffusely diseased³⁸

Philips is here to help you achieve better outcomes in diffuse disease cases

Philips physiology tools and iFR Co-registration on IntraSight*:

Map iFR physiological drops to understand whether there is diffuse or focal disease.
Make length measurements without a pullback device, plan your procedure and see the physiologic impact of a virtual stent.

Philips IVUS and IVUS Co-registration on IntraSight*:

Guide stenting of the most severely diseased areas, sparing the need for implantation of long stents and can be associated with better outcomes.³⁹
Study data (IVUS-XPL) reported IVUS was associated with a 52% reduction in MACE at 1 year with Xience Prime stents ≥28 mm.⁴⁰

AngioSculpt PTCA scoring balloon catheter:

Treats small distal vessels not amenable to stenting.
Provides improved luminal gain throughout segment, which helps facilitate stent delivery.⁸

ELCA laser atherectomy catheter:

Creates a channel to facilitate definitive therapy delivery.
Prepares long segment to optimize stent and wall apposition (indicated for lesions >20mm).

Educational resources

ELCA case study RCA – Antonis Pratsos, MD

Philips image on file

Comparative luminal gain⁸

(P=0.004)

Philips is here to help you prepare to succeed in diffuse disease cases

Philips physiology tools and CoreVision advanced imaging solution:

Map iFR physiological drops to understand whether there is diffuse or focal disease.
Make length measurements without a pullback device, plan your procedure and see the physiologic impact of a virtual stent.

Philips image on file

Philips IVUS and CoreVision advanced imaging solution:

Guide stenting of the most severely diseased areas, sparing the need for implantation of long stents and can be associated with better outcomes.³⁹
Study data (IVUS-XPL) reported IVUS was associated with a 52% reduction in MACE at 1 year with Xience Prime stents ≥28 mm.⁴⁰

AngioSculpt PTCA scoring balloon catheter:

Treats small distal vessels not amenable to stenting.
Provides improved luminal gain throughout segment, which helps facilitate stent delivery.⁸

Comparative luminal gain⁸

(P=0.004)

ELCA laser atherectomy catheter:

Creates a channel to facilitate definitive therapy delivery.
Prepares long segment to optimize stent and wall apposition (indicated for lesions >20mm).

Educational resources

ELCA case study RCA – Antonis Pratsos, MD

Left main disease

Significant left main CAD (greater than 50%) is found in 4-6% of all patients who undergo coronary angiography.⁴¹

Image courtesy of Jaikirshan Khatri, MD, FACC, FSCAI

Clinical challenges

Left main angiography is highly uncertain⁴²and can underestimate lesion severity.⁴³
Potential dire consequences of stent thrombosis or restenosis.⁴⁴
Left main disease is associated with multi-vessel CAD about 70% of the time.^45,46

Philips is here to help you achieve better outcomes in left main lesion disease

Philips IVUS and IVUS Co-registration on IntraSight*:

Assist in identifying the plaque distribution, vessel size and help avoid geographic miss of therapy delivery with IVUS Co-registration.
Are backed by ACC/AHA Class IIa usage guidance for left main.⁴⁷
Provide better patient outcomes as an IVUS-guided strategy is associated with 70% reduction in all-cause mortality out to 3 years.⁴⁸

AngioSculpt PTCA scoring balloon catheter:

Has a large working range (2 ATM up to 20 ATM) allowing you to quickly tailor you strategy to the vessel size.
Data shows that lesion preparation with a circumferential scoring element led to a numerically larger lumen and low TLR rates in left main interventions.⁴⁹

Educational resources

ELCA case review – Jaikirshan (Jai) Khatri, MD, FACC, FSCAI

70% reduction in all-cause mortality out to 3 yrs⁴⁸

Philips is here to help you prepare to succeed in left main lesion disease

Philips IVUS and CoreVision advanced imaging solution:

Assist in identifying the plaque distribution, vessel size and help avoid geographic miss of therapy delivery with IVUS Co-registration.
Are backed by ACC/AHA Class IIa usage guidance for left main.⁴⁷
Provide better patient outcomes as an IVUS-guided strategy is associated with 70% reduction in all-cause mortality out to 3 years.⁴⁸

70% reduction in all-cause mortality out to 3 yrs⁴⁸

AngioSculpt PTCA scoring balloon catheter:

Has a large working range (2 ATM up to 20 ATM) allowing you to quickly tailor you strategy to the vessel size.
Data shows that lesion preparation with a circumferential scoring element led to a numerically larger lumen and low TLR rates in left main interventions.⁴⁹

Educational resources

ELCA case review – Jaikirshan (Jai) Khatri, MD, FACC, FSCAI

Saphenous vein graft and thrombus lesions

Saphenous vein graft (SVG) occlusion during the first year is high at 15%, and 10-year patency is only 60%.^50,51,52,53

Philips image on file

Clinical challenges

Tough fibrotic lesions are at the anastomosis site.
There is a risk of distal emboli.
Safe delivery of embolic protection.
Higher MACE and ISR rates are associated with these cases.^54,55,56

Philips is here to help you achieve better outcomes in SVG and thrombus cases

Philips IVUS and IVUS Co-registration on IntraSight*:

Assist in identifying the extent of thrombus or plaque distribution, vessel sizes and lesion length.
Allow you to more easily correlate plaque and treatment locations to the angiogram with the goal of reduced contrast load and radiation exposure with IVUS Co-registration.

AngioSculpt PTCA scoring balloon catheter:

Is the only specialty balloon indicated for type C lesions.
Provides maximal lumen gain under low pressure (nominal 8 ATM).

ELCA laser atherectomy catheter:

Is the only coronary atherectomy device with an SVG indication.
Vaporizes the plaque and often used to assist in delivering embolic protection.

Educational resources

ELCA SVG case review – Antonis Pratsos, MD

Philips video on file - ELCA laser catheter

Educational resources

ELCA SVG case review – Antonis Pratsos, MD

ELCA SVG case review

Educational opportunities and trainings

Educating leaders in intravascular imaging and therapy excellence

Philips ELIITE Academy is focused on delivering high value and real-time strategic educational programs that meet the evolving needs of our customers.

To initiate your clinical pathway or register for one our cardiovascular US medical educational programs, please contact your local Philips representative.

For more information on the available courses, please visit www.philipseliiteacademy.com.

See more clearly, and treat optimally in complex PCI cases with our specialty coronary diagnostic and therapy devices

ELCA coronary laser atherectomy catheter

View product

AngioSculpt PTCA scoring balloon catheter

View product

IntraSight interventional applications platform with co-registration

View product

Eagle Eye Platinum digital IVUS catheter

View product

Eagle Eye Platinum ST digital IVUS catheter

View product

Refinity ST rotational IVUS catheter

View product

iFR Co-registration technology

View product

IVUS imaging

View product

Verrata Plus pressure guide wire

View product

Resources

Educational resources

IVUS Information

iFR/FFR information

Eagle Eye Platinum IVUS pocket guide

Downloadable iOS app

Coronary IVUS app

References and safety information

Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470.
Cassese S, Byrne RA, Tada T, et al. Incidence and predictors of restenosis after coronary stenting in 10,004 patients with surveillance angiography. Heart 2014; 100:153–9.
Dangas et a. In-Stent Restenosis in the Drug-Eluting Stent Era. J Am Coll Cardiol 2010; 56:1897–907.
Bhatt D. Treatment of In-Stent Restenosis, Excerpt from Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease. Philadelphia: Elsevier 2016:209-222.
Ota H. Novel Approaches for Cardiovascular Drug-Eluting Devices Cardiovasc Revasc Med. 2015; 16:84-89; Maluenda G. Intracoronary brachytherapy for Recurrent Drug-Eluting Stent Failure CardiovascInterv. 2012;5:12-19; Kubo S. Differential relative efficacy between drug-eluting stents in patients with bare metal and drug-eluting stent restenosis Euro Intervention. 2013;9:788-796; Latib A. Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosisJACC Cardiovasc Interv. 2011;4:155-164.
Pratsos, A. (2009). Atherectomy and the role of excimer laser in treating CAD. Cardiac Interventions Today, January/February, 27-34.
Levine G et al, 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, Catheterization and Cardiovascular Interventions 00:000–000 (2011).
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.
Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9.
Patel et al. Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions. Catheter Cardiovasc Interv 2013 June 1. In press doi: 10.1002/ccd.25034.)
Iakovou I, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug eluting stents. JAMA 2005;293:2126:2130.
Kim, S, Kim Y, et al, Long-Term Outcomes of Intravascular Ultrasound-Guided Stenting in Coronary Bifurcation Lesions, Am J Cardiol 2010;106:612– 618.
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.
Stone, G., et. al. (2005). Percutaneous recanalization of chronically occluded coronary arteries: A consensus document: Part 1. Circulation, 112, 2364- 2372.
National Cardiac Data Registry -2016
Rasmussen, K., et al. (2010). Efficacy and safety of zotarolimus-eluting and sirolimus-eluting coronary stents in routine clinical care(SORT OUT III): A randomized controlled superiority trial. The Lancet, 375(9720), 1090-1099.
Byrne, R.A., Kastrati, A., et. al. (2009). Randomized, non-inferiority trial of three limus agent-eluting stents with different polymer coatings: the intracoronary stenting and angiographic results: Test efficacy of 3 limus-eluting stents (ISAR-TEST-4) trial. Eur Heart J, 30, 2441-2449.
Kim BK, Shin DH, Hong MK, et al. Clinical impact of intravascular ultrasound-guided chronic total occlusion intervention with zotarolimus-eluting versus biolimus-eluting stent implantation: randomized study. Circ Cardiovasc Interv 2015;8:e002592.
AngioSculpt Test plan ST-1197 (2008) on file at AngioScore, Inc.
Luc Bilodeau, MD, et al. Novel Use of a High-Energy Excimer Laser Catheter for Calcified and Complex Coronary Artery Lesions. Catheterization and Cardiovascular Interventions (62:155-161, 2004).
JACC Vol. 63, No. 18, 2014.
Circulation 1991;83:1764–70.
Eur Heart J 1998;19:1224–31.
Cardiovasc Revasc Med 2008;9:2–8.
Vavuranakis M, Toutouzas K, Stefanadis C, et al. Stent deploymentin calcified lesions: can we overcome calcific restraint with highpressure balloon inflations? Catheter Cardiovasc Interv 2001;52:
Doi H, Maehara A, Mintz GS, et al. Impact of post-intervention minimal stent area on 9-month follow-up patency of paclitaxelelutingstents: an integrated intravascular ultrasound analysis from the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials. J Am Coll Cardiol Intv 2009;2: 1269–75.
Liu X, Doi H, Maehara A, et al. A volumetric intravascular ultrasound comparison of early drug-eluting stent thrombosis versus restenosis. J Am Coll Cardiol Intv 2009;2:428–34.
J Am Coll Cardiol 1995;25:855–65.
Agatston AS, Janowitz WR, Hildner FJ, et al. Quantiﬁcation of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol 1990;15:827–32.
Mintz GS, Popma JJ, Pichard AD, et al. Patterns of calciﬁcation in coronary artery disease. A statistical analysis of intravascular ultra-sound and coronary angiography in 1155 lesions. Circulation 1995;91: 1959–65.
Tuzcu EM, Berkalp B, De Franco AC, et al. The dilemma of diag-nosing coronary calciﬁcation: angiography versus intravascular ultra-sound. J Am Coll Cardiol 1996;27:832–8.
Xu B., Gao R. L., Zhang R. Y., et al. Efficacy and safety of FIREHAWK abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort. Chinese Medical Journal. 2013;126(6):1026–1032.
Ahn J. M., Park D. W., Kim Y. H., et al. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions a randomized LONG-DES IV trial. Circulation: Cardiovascular Interventions. 2012;5(5):633–640.
Lee CW, Park DW, Lee BK, et al. Predictors of restenosis after placement of drug-eluting stents in one or more coronary arteries. Am J Cardiol 2006;97:506–11.
D’Ascenzo F, Bollati M, Clementi F, et al. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol 2013;167:575–84.
Degertekin M., Arampatzis C. A., Lemos P. A., et al. Very long sirolimus-eluting stent implantation for de novo coronary lesions. The American Journal of Cardiology. 2004;93(7):826–829.
K.L. Gould, Y. Nakagawa, K. Nakagawa, et al., Frequency and clinical implications of fluid dynamically significant diffuse coronary artery disease manifest as graded, longitudinal, base-to-apex myocardial perfusion abnormalities bynoninvasive positron emission tomography, Circulation 101 (2000) 1931-1939.
R. Bigi, L. Cortigiani, P. Colombo, A. Desideri, J.J. Bax, O. Parodi, Prognostic and clinical correlates of angiographically diffuse non-obstructive coronary lesions, Heart 89 (2003) 1009-1013.
Colombo A, De Gregorio J, Moussa I, et al. Intravascular ultrasound‐guided percutaneous transluminal coronary angioplasty with provisional spot stenting for treatment of long coronary lesions. J Am Coll Cardiol 2001; 38(5):1427–1433.
Ref=Hong, S-J et al. Effect of Intravascular Ultrasound–Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial. JAMA, published online November 10, 2015.
Ragosta M, Dee S, Sarembock IJ, et al. Prevalence of unfavorable angiographic characteristics for percutaneous intervention in patients with unprotected left main coronary artery disease. Catheter Cardiovasc Interv 2006; 68:357.
Lindstaedt M, et al. How good are experienced interventional cardiologists at predicting the functional significance of intermediate or equivocal left main coronary artery stenoses? Int J Cardiol. 2007;120:254-6.
Arnett, E. N. et al. Coronary artery narrowing in coronary heart disease: comparison of cineangiographic and necropsy findings. Ann. Intern. Med. 91, 350–356 (1979).
Puri R., et al. “Optimizing Outcomes During Left Main Percutaneous Coronary Intervention With Intravascular Ultrasound and Fractional Flow Reserve” JACC Card. Interv. 2012 5(7): 697-707.
Taggart DP, Kaul S, Boden WE, et al. Revascularization for unprotected left main stem coronary artery stenosis stenting or surgery. J Am Coll Cardiol 2008; 51:885.
Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med 2009; 360:961.
Levine G et al, 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, Catheterization and Cardiovascular Interventions 00:000–000 (2011).
Park SJ, Kim YH, Park DW, et al. “Impact Of Intravascular Ultrasound Guidance On Long-term Mortality In Stenting For Unprotected Left Main Coronary Artery Stenosis” Circ Cardiovasc Interv. 2009 Jun;2(3):167-77.
Schmidt,T. Safety and efficacy of lesion preparation with AngioSculpt Scoring Balloon in left main interventions: the ALSTER Left Main registry.
Campeau L, Enjalbert M, Lesperance J, et al. The relation of risk factors to the development of atherosclerosis in saphenous vein bypass grafts and the progression of disease in the native circulation: a study 10 years after aortocoronary bypass surgery. N Engl J Med. 1984;311(21):1329-1332.
Bourassa MG. Fate of venous grafts: the past, the present, and the future. J Am Coll Cardiol. 1991;5(5):1081-1083.
Fitzgibbon GM, Kafka HP, Leach AJ, et al. Coronary bypass graft fate and patient outcome: angiographic follow-up of 5065 grafts related to survival and reoperation in 1388 patients during 25 years. J Am Coll Cardiol. 1996;28(3):616-626.
Goldman S, Zadina K, Moritz T, et al. Long-term patency of saphenous vein and left internal mammary artery grafts after coronary artery bypass surgery: results from a Department of Veterans Affairs Cooperative Study. J Am Coll Cardiol. 2004;44(11);2149-2156.
de Feyter PJ, van Suylen RJ, de Jaegere PP, et al. Balloon angioplasty for the treatment of lesions in saphenous vein bypass grafts. J Am Coll Cardiol. 1993;21(7):1539-1549.
Morrison DA, Crowley ST, Veerakul G, et al. Percutaneous transluminal angioplasty of saphenous vein grafts for medically refractory unstable angina. J Am Coll Cardiol. 1994;23(5):1066-1070.
Plokker HW, Meester BH, Serruys PW. The Dutch experience in percutaneous transluminal angioplasty of narrowed saphenous veins used for aortocoronary arterial bypass. Am J Cardiol. 1991;67(5):361-366.

ELCA important safety information
Indications: The laser catheters are intended for use either as a stand-alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (PTCA) in patients who are acceptable candidates for coronary artery bypass graft (CABG) surgery. The following indications for use, contraindications and warnings have been established through multicenter clinical trials. The Philips CVX-300 Excimer laser system and the multi-fiber laser catheter models are safe and effective for the following indications: occluded saphenous vein bypass grafts, ostial lesions, long lesions (greater than 20mm in length), moderately calcified stenosis, total occlusions traversable by a guidewire, lesions which previously failed balloon angioplasty, restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography.
Contraindications: Lesion is in an unprotected left main artery. Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverse. Guidewire cannot be passed through the lesion. Lesion is located within a bifurcation. Patient is not an acceptable candidate for bypass graft surgery.
Potential adverse events: Use of the Philips CVX-300 Excimer laser system may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death. No long term adverse effects of ELCA are known at this time.
Risks: The primary endpoint defined in the laser angioplasty of restenosis stents (LARS) randomized trial was the absence of major adverse cardiac events (MACE) at 6 months: Death; myocardial infarction; coronary artery bypass surgery. Procedural complications include: any dissection, acute thrombus, haziness, no reflow, arrhythmia, acute vessel closure, occlusion of side branch, occlusion non-target, coronary spasm, coronary embolism, coronary perforation, laser/stent damage, balloon/stent damage, and other serious.

AngioSculpt PTCA important safety information
The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.
The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a significant stenosis.
Possible adverse effects include, but are not limited to: death; heart attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular arrhythmias); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection.
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
Caution: Federal law restricts the devices referenced on this site to sale by or on the order of a physician.

How can we help you?

Contact information

* This field is mandatory

Country

First name*

First name (phonetic)

Last name*

Last name (phonetic)

Salutation

Academic title

Email address*

Business phone

Company*

Job title

Industry

Function

Specialty

Department

State or Province

City

Address

Zip or Postal Code

By specifying your reason for contact we will be able to provide you with a better service.

We work with partners and distributors who may contact you about this Philips product on our behalf.

Follow up information

Preferred method of contact

Best time to call

Estimated time of purchase

Comments

What is cross border data transfer?

I agree on cross-border transfer of personal information.

CEE specific legal checkbox

I would like to receive marketing related electronic communications about Philips products, services, events and promotions that may be relevant to me based on my user preferences and behavior.

Final CEE consent

See clearly. Treat optimally.

Philips coronary solutions give you the visualization needed to quickly and precisely assess complex PCI challenges so you can treat optimally with Philips therapeutic solutions.

In-stent restenosis (ISR)

Rates of restenosis at follow up2

Clinical challenges

Risk of restenosis

Angiography cannot determine the mechanism of ISR

Clinical challenges

Risk of restenosis

Angiography cannot determine the mechanism of ISR

Philips is here to help you achieve better outcomes in ISR cases

Ostial and bifurcation lesions

Clinical challenges

Philips is here to help you achieve better outcomes in ostial and bifurcation cases:

Chronic total occulsions (CTOs)

Clinical challenges

Philips is here to help you achieve better outcomes in CTO cases

Calcified lesions

Clinical challenges

Philips is here to help you achieve better outcomes in calcified lesion cases

Diffuse disease

Clinical challenges

Philips is here to help you achieve better outcomes in diffuse disease cases

Philips is here to help you prepare to succeed in diffuse disease cases

Left main disease

Clinical challenges

Philips is here to help you achieve better outcomes in left main lesion disease

Philips is here to help you prepare to succeed in left main lesion disease

Saphenous vein graft and thrombus lesions

Clinical challenges

Philips is here to help you achieve better outcomes in SVG and thrombus cases

Educational opportunities and trainings

Educating leaders in intravascular imaging and therapy excellence

See more clearly, and treat optimally in complex PCI cases with our specialty coronary diagnostic and therapy devices

Resources

Contact information

Rates of restenosis at follow up²