P. Krishnan, et al. Circulation 2017;136:11002-1113.
Schroeder H, et al. Circulation 2017;135:2227-2236.
Jaff M. Drug-coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort. (Updated data from IN.PACT SFA presented on slide 12) Oral Presentation at: VIVA 2016; September 19-22, 2016; Las Vegas, NV.
IN.PACT Summary of Safety and Effectiveness Data (SSED).
Rosenfield K, Jaff MR, White CJ, et al. NEJM. 2015;373:145-153. Lutonix Summary of Safety and Effectiveness Data (SSED).
Zeller T. Oral presentation. 12-month results of the ILLUMENATE global study with Stellarex DCB. LINC 2017. Bad Krozingen. Germany; Jan 24, 2017.
Granada JF. Future directions, clinical applications and local drug delivery technologies. Presented at the Transcatheter Cardiovascular Therapeutics (TCT) 25th Annual Scientific Symposium. Oct. 27-Nov. 1, 2013. San Francisco, CA. Slide 7, 15.
Schroeder H, Meyer DR, Lux B, et al. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study. Catheter Cadiovasc Interv. 2015;86:278-286.
Philips data on file.
Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110(7):810-814.
Superimposed PK curves from different datasets: Melder R, EuroPCR 2012, Yazdani, et al. Catheterization and Cardiovascular Interventions 2014;83:132-140. Data on file at Philips.
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.
Dake et al. Circ Cardiovasc Interv. 2011; 4:495‐504 (Zilver)
Matsumura et al. J Vasc Surg 2013;58:73‐83; EverFlex SE Peripheral Stent System Summary of Safety and Effectiveness; Data www.accessdata.fda.gov/cdrh_docs/pdf11/P110023b.pdf
Garcia et al. Circ Cardiovasc. Interv. 2015; 8e000937 (Superb)
Laird et al. Circ Cardiovasc Interv. 2010;3:267‐276 (Lifestent)
Brodmann M. Oral Presentation. VIVA; Sept 13, 2017, Las Vegas, NV
Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. 2017 Final Rule (CMS-1656-CN). Published in the Federal Register. November 14, 2016. OPPS Addendum B.
Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. 2018 Final Rule (CMS-1678-CN). Published in the Federal Register. December 14, 2017. OPPS Addendum B and ASC Addenda AA-EE.
Medicare Inpatient Prospective Payment System 2018 Final Rule (CMS-1677-CN) Federal Register Vol. 82 No. 191, October 4, 2017. Table 5 CN. Payment rates assume full update amount for hospitals that have submitted quality data and hospitals have a wage index greater than 1.
Medicare Physician Fee Schedule. Final Policy, Payment, and Quality Provisions in the Medicare Physician Fee Schedule for Calendar Year 2018, (CMS-1676-F), November 2, 2017. Federal Register Vol. 82, No. 219. Addendum B, 2018 conversion factor 35.9996.
IPPS FY2017 Final Rule and Correction Notice. Impact file CN: Tables 1 CN, 5 CN and 16 CN.
Rocha-Sing LINC. January 24-27, 2017. Leipzig, Germany.
Rocha-Singh CCI 83:E212-E220 (2014)
Holden. Comparing trial data in the management of calcified arteries. Charing Cross 2018; April 24-25, 2018; London, UK.
Stellarex IFU. P011966-D.
Medtronic In.Pact Instructions for Use, M052624T001 Rev 1F.
Bard Lutonix Instructions for Use, BAW1387400r3.
Philips data on file. D044595.
Granada JF, Milewski K, Zhao H, et al. Vascular response to zotarolimus-coated balloons in injured superficial femoral arteries of the familial hypercholesterolemic swine. Circ Cardiovasc Interv. 2011;4:447-455.
Philips data on file. D035594.
Mark J, et al. Physical properties of polymers. 3rd ed. Cambridge University Press. 2004.
Laird, et al. J Am Coll Cardio. 2015;66:2329-2338.
Mathews J. ILLUMENATE Pivotal Stellarex DCB IDE study 2-year outcomes. NCVH. New Orleans, LA. May 30, 2018.
Zeller, Linc. ILLUMENATE Global: 2-year results with the Stellarex DCB in femoropopliteal lesions. Leipzig, Germany. 2018.
DISCLAIMER: This website is intended for physician education only. Patients should consult with their physician with questions related to PAD.
All cited trademarks are the property of their respective owners.
Stellarex™ is a Class III medical device, CE0086.
IMPORTANT SAFETY INFORMATION
The Stellarex 0.035" OTW drug-coated angioplasty balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation of de novo or restenotic lesions up to 180mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.
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
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 that requires surgical repair; 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.
Additional complications that 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, leukopenia, thrombocytopenia); Hepatic enzyme changes; Histologic changes in vessel wall including inflammation, cellular damage or necrosis; Myalgia/Arthralgia; Myelosuppression; Peripheral neuropathy.