See clearly. Treat optimally.
Efficient and proven solutions for optimal patient outcomes
Optimal patient outcomes start with the power of IVUS. IVUS allows you to accurately assess the disease state within the vessel by providing lesion characteristics that are critical to effective utilization of drug-coated balloon technologies. Philips Drug-Coated Angioplasty Balloon Catheter – Stellarex is proven to be an easy, efficient and effective solution, even in the most challenging cases.1,2,3,4
Delivering deeper insights to guide precise treatment plans
IVUS provides a 360-degree vessel view, detailing vessel sizing and plaque morphology with pinpoint accuracy, allowing you to select the optional treatment plan for your patients. Here’s how Philips IVUS allows you to see clearly, treat optimally:
Identifies plaque burden location for precise treatment
Guides device sizing to ensure precise drug delivery
Provides insights on plaque type to guide device selection
Confirms true lumen or sub-intimal guidewire location
IVUS leads to significantly better outcomes for DCBs
89.1%
sustained clinical improvement [5]
A recently published RCT comparing IVUS guided vs angiography guided angioplasty for the outcomes of DCB in the treatment of femoropopliteal artery disease demonstrated statistically significant better sustained clinical improvement when IVUS was used (89.1 v 76.3%, p=0.02)
82.4%
sustained hemodynamic improvement [5]
A recently published RCT comparing IVUS guided vs angiography guided angioplasty for the outcomes of DCB in the treatment of femoropopliteal artery disease demonstrated statistically significant better sustained hemodynamic improvement when IVUS was used (82.4% v 66.9%, p=0.02)
The intersection of imaging and therapy
Our clinically backed peripheral vascular portfolio provides advanced imaging and specialized treatment options so you can effectively and efficiently maximize patient outcomes
The only plug-and-play IVUS platform available
Best-in-class mobile or integrated platform built for smart, simple and seamless lab integration, ready for tomorrow’s innovations
Complete portfolio of IVUS catheters
Offering rapid exchange and OTW options to meet your workflow style. Our IVUS portfolio boasts the only IVUS-guided re-entry device, Pioneer Plus
Reduced drug loss and transit time with Stellarex
Proprietary EnduraCoat technology reduces drug loss during transit, meaning no transit time requirements or loading tool [1,2]
Stellarex delivers durable long-term outcomes
Stellarex provides durable long-term outcomes (72.2% freedom from CD-TLR through 5 years), even in a complex patient population [4]
IVUS changed treatment plans in 79% of arterial cases studied [6]
Angiography alone provides details on luminal characteristics, but severely underestimates the extent of disease, even in “normal appearing” vessels [7]. IVUS gives you pinpoint accuracy on vessel sizing, plaque morphology and geometry and guidewire position so you can get it right the first time.
Stellarex provides outcomes to easily, effectively and efficiently treat common-to-complex lesions.
- Key safety (91.1%) and efficacy (91.5%) endpoints at 12 months in a real-world patient population [8]. - 89.4% in the complex patient cohort at 12 months in a real-world patient population [9].
Anytime I go inside a blood vessel, I use intravascular ultrasound… the quality of my intervention goes up significantly.
Bryan T. Fisher, Sr., MD
Vascular Surgeon
HCA Healthcare
Footnotes
- Stellarex IFU. P016381 rev D
- Data on file. D044595-00
- Stellarex, Ranger, Lutonix, IN.PACT, and SurVeil IFUs
- Zeller T. ILLUMENATE Global 5-Year Results. ISET 2023. January 16-19, 2023; Miami Beach, FL
- Ko, Y. G., Lee, S. J., Ahn, C. M., Lee, S. H., Lee, Y. J., Kim, B. K., Hong, M. K., Jang, Y., Kim, T. H., Park, H. W., Jang, J. Y., Lee, J. H., Park, J. H., Kim, S. H., Im, E., Park, S. H., Choi, D., & IVUS-DCB investigators (2024). Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial. European heart journal, 45(31), 2839–2847. doi.org/10.1093/eurheartj/ehae372
- Allan R, Puckridge P, Spark J, et al. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions. J Am Coll Cardiol Intv. 2022 Mar, 15 (5) 536–546. https://doi.org/10.1016/j.jcin.2022.01.001
- Kashyap VS, Pavkov ML, Bishop PD, et al. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther. 2008;15(1):117-125.
- Stavroulakis. Real World Evidence of Stellarex Drug-Coated Balloon for the Treatment of Infrainguinal Disease: Final 12-Month Results from the Stellarex Vascular E-Registry (SAVER). CIRSE 2021. September 25-28. Online.
- Tepe. Stellarex DCB in the Complex Patient: Analysis of the SAVER Registry. ISET 2022. January 16-19, 2022. Hollywood, FL
- Venkatasubbu GD, et al. Surface modification and paclitaxel drug delivery of folic acid modified polyethylene glycol functionalized hydroxyapatite nanoparticles. Powder Technology. 2013;235:437-442.
Disclaimer
Caution: Federal law restricts this device to sale by or on the order of a physician.
Important safety information
Drug-Coated Angioplasty Balloon Catheter – Stellarex
Indications for Use
The Stellarex 0.035” OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Contraindications
- The Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon is contraindicated for use in:
- Patients with known hypersensitivity to paclitaxel or structurally related compounds.
- Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy.
- Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children.
- Coronary arteries, renal arteries, and supra- aortic/cerebrovascular arteries.
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
Potential Adverse Events
Possible adverse effects associated with the balloon dilation procedure include, but are not limited to: Abrupt vessel closure; Allergic reaction to contrast medium, antiplatelet therapy, or catheter system components (drug, excipients, and materials); Amputation/ Loss of limb; Arrhythmias; Arterial aneurysm; Thrombosis; Arterio-venous fistula (AVF); Bleeding; Death; Embolism/Device embolism; Fever; Hematoma; Hemorrhage; Hypertension/Hypotension; Infection or pain at insertion site; Inflammation; Ischemia or infarction of tissue/organ; Occlusion; Pain or tenderness; Peripheral edema; Pseudoaneurysm; Renal insufficiency or failure; Restenosis; Sepsis or systemic infection; Shock; Stroke/Cerebrovascular accident; Vessel dissection, perforation, rupture, spasm, or recoil; Vessel trauma which requires surgical repair. Potential complications of peripheral balloon catheterization include, but are not limited to: Balloon rupture; Detachment of a component of the balloon and/or catheter system; Failure of the balloon to perform as intended; Failure to cross the lesion. Potential complications which may be associated with the addition of paclitaxel to the balloon include, but may not be limited to the following: Allergic/immunologic reaction to paclitaxel; Alopecia; Anemia; Gastrointestinal symptoms (diarrhea, nausea, pain, vomiting); Hematologic dyscrasia (including neutropenia, leucopenia, thrombocytopenia); Hepatic enzyme changes; Histologic changes in vessel wall including inflammation, cellular damage, or necrosis; Myalgia/Arthralgia; Myelosuppression; Peripheral neuropathy
See clearly. Treat optimally.