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1

Thieme, Marcus, Peter Von Bilderling, Christian Paetzel, Dimitrios Karnabatidis, Julio Perez Delgado, and Michael Lichtenberg. "The 24-Month Results of the Lutonix Global SFA Registry." JACC: Cardiovascular Interventions 10, no. 16 (August 2017): 1682–90. http://dx.doi.org/10.1016/j.jcin.2017.04.041.

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2

Steiner, Sabine, Andrej Schmidt, Yvonne Bausback, Sven Bräunlich, Matthias Ulrich, Ursula Banning-Eichenseer, and Dierk Scheinert. "Single-Center Experience With Lutonix Drug-Coated Balloons in Infrapopliteal Arteries." Journal of Endovascular Therapy 23, no. 3 (April 20, 2016): 417–23. http://dx.doi.org/10.1177/1526602816645080.

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3

Montero-Baker, Miguel. "LEA 13. Lutonix Drug-Coated Balloon Long Lesion Study: 24-Month Outcomes." Journal of Vascular Surgery 68, no. 5 (November 2018): e118. http://dx.doi.org/10.1016/j.jvs.2018.08.024.

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4

Scheinert, Dierk, Stephan Duda, Thomas Zeller, Hans Krankenberg, Jens Ricke, Marc Bosiers, Gunnar Tepe, Scott Naisbitt, and Kenneth Rosenfield. "The LEVANT I (Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis) Trial for Femoropopliteal Revascularization." JACC: Cardiovascular Interventions 7, no. 1 (January 2014): 10–19. http://dx.doi.org/10.1016/j.jcin.2013.05.022.

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5

Kitrou, P., and P. Kitrou. "03:45 PM Abstract No. 358 The Lutonix Global AV Registry: final 6-month results and subgroup analysis." Journal of Vascular and Interventional Radiology 30, no. 3 (March 2019): S158. http://dx.doi.org/10.1016/j.jvir.2018.12.430.

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6

Metzger, D. Christopher, and Joseph Giorgianni. "TCT-17 The Lutonix Global DCB Registry Real World Patients with Complex Femero-popliteal Lesions – 24 Month Outcomes." Journal of the American College of Cardiology 68, no. 18 (November 2016): B7—B8. http://dx.doi.org/10.1016/j.jacc.2016.09.894.

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7

Trerotola, Scott O., Theodore F. Saad, and Prabir Roy-Chaudhury. "The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis." Journal of Vascular and Interventional Radiology 31, no. 1 (January 2020): 1–14. http://dx.doi.org/10.1016/j.jvir.2019.08.035.

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8

Mustapha, J. A., M. Brodmann, P. J. Geraghty, F. Saab, R. A. Settlage, and M. R. Jaff. "Drug-Coated Versus Uncoated Percutaneous Transluminal Angioplasty in Infra-popliteal Arteries: Six-Month Results of the Lutonix BTK Trial." Journal of Vascular Surgery 70, no. 5 (November 2019): 1718. http://dx.doi.org/10.1016/j.jvs.2019.08.011.

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9

Granada, Juan F., Renu Virmani, Daniel Schulz-Jander, Stefan Tunev, and Robert J. Melder. "Rate of Drug Coating Dissolution Determines In-Tissue Drug Retention and Durability of Biological Efficacy." Journal of Drug Delivery 2019 (January 8, 2019): 1–7. http://dx.doi.org/10.1155/2019/9560592.

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Two different drug-coated balloons (DCBs) possessing different coating formulations were compared for rate of coating dissolution in vitro, in addition to tissue drug concentration and histological responses of treated vascular tissue in vivo, to determine if the rate of drug bioavailability to vascular tissue can impact the degree and duration of the observed pharmacological response to locally delivered drug. In vitro dissolution comparison demonstrated that a urea/paclitaxel-based coating formulation (IN.PACT™ Admiral™) released drug from solid to soluble phase at a slower and constant rate, yielding approximately 7% solubilized drug in 24 h. In contrast, a coating formulated from polysorbate/sorbitol/paclitaxel (Lutonix™) released 51% of solid phase drug to soluble phase in 1 h of dissolution with the remainder solubilizing in 24 h. In vivo evaluation of tissue drug concentration of both products showed significantly different tissue pharmacokinetic profile, with a higher concentration of paclitaxel in tissue at 90 days with a urea-based formulation excipient. Histological comparison of smooth muscle cell loss in response to drug exposure revealed contrasting trends of smooth muscle cell loss from 28 to 90 days with significantly higher response to drug observed at 90 days with the urea-based formulation. Rapid dissolution of drug from the polysorbate/sorbitol coating formulation was associated with an early increase in local cellular response to drug which diminished over 90 days with clearance of local drug from tissue. Sustained long-term drug-in-tissue concentration associated with the urea-based formulation demonstrated sustained pharmacological activity at 90 days, suggesting that slow coating dissolution provides a sustainable long-term tissue response.
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10

Kolodgie, Frank D., Erica Pacheco, Kazuyuki Yahagi, Hiroyoshi Mori, Elena Ladich, and Renu Virmani. "Comparison of Particulate Embolization after Femoral Artery Treatment with IN.PACT Admiral versus Lutonix 035 Paclitaxel-Coated Balloons in Healthy Swine." Journal of Vascular and Interventional Radiology 27, no. 11 (November 2016): 1676–85. http://dx.doi.org/10.1016/j.jvir.2016.06.036.

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11

Delatore, P., S. Hollmann, and N. Ferko. "Cost analyses of Lutonix® 035 DCB PTA catheters for the treatment of Femoropopliteal Artery Stenosis: A U.S. Hospital perspective." Value in Health 18, no. 3 (May 2015): A41. http://dx.doi.org/10.1016/j.jval.2015.03.246.

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12

Escárcega, Ricardo O., and Ron Waksman. "Overview of the 2014 Food and Drug Administration Circulatory System Devices Panel meeting regarding the Lutonix® drug coated balloon." Cardiovascular Revascularization Medicine 15, no. 8 (November 2014): 402–7. http://dx.doi.org/10.1016/j.carrev.2014.10.006.

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13

Niazi, Khusrow, Bharati Manda, Corinne LeReun, and LIesl Strachan. "TCT-642 Drug-Coated Balloon Indirect Treatment Comparison: IN.PACT™ versus Lutonix™ in the Treatment of Peripheral Arterial Disease." Journal of the American College of Cardiology 70, no. 18 (October 2017): B283. http://dx.doi.org/10.1016/j.jacc.2017.09.891.

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14

Delatore, P., S. Hollmann, and N. Ferko. "ECONOMIC ANALYSES OF LUTONIX® 035 DCB PTA CATHETERS FOR THE TREATMENT OF FEMOROPOPLITEAL ARTERY STENOSIS: AN UPDATED US HOSPITAL PERSPECTIVE." Value in Health 19, no. 3 (May 2016): A299. http://dx.doi.org/10.1016/j.jval.2016.03.693.

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15

Shammas, Nicolas W., and Edward Y. Woo. "CRT-300.29 Focal-Force Scoring Balloons Prior to Lutonix® 035 DCB Treatment of Femoropopliteal Denovo or Non-Stent Femoropopliteal Arterial Disease." JACC: Cardiovascular Interventions 10, no. 3 (February 2017): S47—S48. http://dx.doi.org/10.1016/j.jcin.2016.12.165.

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16

Mustapha, Jihad. "TCT-3 The Lutonix® Global Drug Coated Balloon Registry Real World Patients with Below the Knee Disease – Interim 12 Month Outcomes." Journal of the American College of Cardiology 72, no. 13 (September 2018): B2. http://dx.doi.org/10.1016/j.jacc.2018.08.1078.

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17

Scheinert, Dierk, Andrej Schmidt, Thomas Zeller, Stefan Müller-Hülsbeck, Sebastian Sixt, Henrik Schröder, Norbert Weiss, et al. "German Center Subanalysis of the LEVANT 2 Global Randomized Study of the Lutonix Drug-Coated Balloon in the Treatment of Femoropopliteal Occlusive Disease." Journal of Endovascular Therapy 23, no. 3 (April 26, 2016): 409–16. http://dx.doi.org/10.1177/1526602816644592.

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18

Barclay, B., P. Delatore, N. Ferko, and S. Hollmann. "Economic Analysis Of The Lutonix® 035 Drug Coated Balloon Pta Catheter For The Treatment Of Vascular Access Stenosis In Patients With Arteriovenous Fistulas." Value in Health 20, no. 9 (October 2017): A576. http://dx.doi.org/10.1016/j.jval.2017.08.1008.

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19

Geraghty, P. "03:18 PM Abstract No. 15 Lutonix below-the-knee global drug-coated balloon IDE study: primary endpoint outcomes at 6 months and safety subgroup analyses." Journal of Vascular and Interventional Radiology 30, no. 3 (March 2019): S10. http://dx.doi.org/10.1016/j.jvir.2018.12.052.

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20

Beasley, R. "3:45 PM Abstract No. 156 ■ FEATURED ABSTRACT The Lutonix ® Global DCB Registry real-world patients with below-the-knee disease: interim 6-month outcomes." Journal of Vascular and Interventional Radiology 29, no. 4 (April 2018): S70. http://dx.doi.org/10.1016/j.jvir.2018.01.176.

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21

Shammas, Nicolas W., and Edward Y. Woo. "LBT-2 Lutonix® Paclitaxel-coated Balloon To Treat Obstructive Lesions In The Superficial Femoral And Popliteal Arteries: Preliminary Six-month Results From The SAFE-DCB Us Registry." JACC: Cardiovascular Interventions 10, no. 3 (February 2017): S1. http://dx.doi.org/10.1016/j.jcin.2016.12.032.

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22

Thieme, Marcus, Michael Lichtenberg, Marianne Brodmann, Angelo Cioppa, and Dierk Scheinert. "Lutonix® 014 DCB global Below the Knee Registry Study: interim 6-month outcomes." Journal of Cardiovascular Surgery 59, no. 2 (March 2018). http://dx.doi.org/10.23736/s0021-9509.18.10269-2.

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23

Case, Brian C., Rebecca Torguson, Cheng Zhang, and Ron Waksman. "Overview of the Virtual 2021 FDA’s Circulatory System Devices Advisory Panel on Lutonix 014 Drug-Coated Percutaneous Transluminal Angioplasty Catheter for Below-the-Knee Lesions in Critical Limb Ischemia." Cardiovascular Revascularization Medicine, June 2021. http://dx.doi.org/10.1016/j.carrev.2021.06.016.

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