Supporting Information and References for the Vascular News Article
“Spur RST: Novel Approach to Addressing Limitations in BTK CLTI”

This page provides additional information related to the article “Spur RST: Novel Approach to Addressing Limitations in BTK CLTI” published in Vascular News (BIBAMedical), Issue 110, April 2026. Here you will find the Indications for Use and Safety Information for the Spur® Peripheral Retrievable Scaffold System. The page also contains the complete list of references cited in the article. For full product information, please refer to the Instructions for Use available below.

CE Indications for Use and Safety Information

Indications for Use:
The Spur® is indicated for treatment of de novo or restenotic infrapopliteal lesions, with reference vessel diameters ranging from 2.5 – 4.5mm, prior to treatment with a commercially available drug coated balloon.

Intended User:
The Spur is intended to treat de novo or restenotic lesions in the infrapopliteal arteries to prepare the vessel for treatment with a commercially available drug coated balloon to enhance drug absorption.

Target Population:
The Spur is intended to treat patients ≥ 18 years of age, with symptomatic infrapopliteal disease.

Contraindications:
The Spur is not intended for use in coronary and cerebral vasculature.

Warnings:
Do not use the device past the expiration date on the label. Use of expired products may result in patient injury. Inspect the device packaging prior to use. Do not use the device if the device packaging has been damaged or if sterility has been compromised. Damaged product could result in patient injury. Ensure the Spur is used with appropriately sized ancillary devices as listed in the section below. Failure to do so could result in inadequate device performance or patient injury. Remove excess slack from the catheter (outside of the patient) to ensure the Spur is recaptured appropriately. If an inability to inflate or maintain balloon pressure occurs, remove the device and use a new one. Do not use excessive force or torque (more than 1 full turn) on the catheter as this could result in damage to the device and result in patient injury.

Precautions:
This device should only be used by physicians experienced in interventional vascular procedures; The system is intended for single (one) use only. DO NOT re-sterilize and/or reuse; Inflate the balloon according to the balloon compliance chart. Balloon pressure should not exceed the rated burst pressure (RBP); Use only the recommended contrast medium to inflate the balloon to ensure adequate delivery; Perform all device manipulations under adequate fluoroscopy; Do not advance or retreat the catheter unless the balloon is fully deflated under vacuum. If resistance is met, determine the cause of the resistance before proceeding; Do not attempt to straighten a catheter if the shaft has become bent or kinked. Instead prepare a new catheter; During the procedure appropriate anticoagulant therapy must be provided to the patient as needed. Antiplatelet therapy should be prescribed post procedure in accordance with the treating physicians routine practice for endovascular procedures; Precautions should be taken when handling the device after exposure to patient, e.g. contact with blood. Used products are considered biohazardous material and should be disposed of properly as per hospital procedure.

View Full CE Instructions for Use: Link to full Spur CE IFU


References

  1. Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. J Vasc Interv Radiol. 2014;25:1489-96, 1496.e1-3. doi: 10.1016/j.jvir.2014.06.018
  2. Baumann F, Fust J, Engelberger RP, et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia. J Endovasc Ther. 2014;21:44-51. doi: 10.1583/13-4486MR.1
  3. Zeller T, Beschorner U, Pilger E, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK’S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015;8:1614-1622. doi: 10.1016/j.jcin.2015.07.011
  4. Zeller T, Baumgartner I, Scheinert D, et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014;64:1568-1576. doi: 10.1016/j.jacc.2014.06.1198.
  5. Mustapha JA, Brodmann M, Geraghty PJ, et al. Drug-coated vs uncoated percutaneous transluminal angioplasty in infrapopliteal arteries: six-month results of the Lutonix BTK trial. J Invasive Cardiol. 2019;31:205-211
  6. Scheinert D, Katsanos K, Zeller T, et al. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012;60:2290-2295. doi: 10.1016/j.jacc.2012.08.989
  7. Rastan A, Tepe G, Krankenberg H, et al. Sirolimus-eluting stents vs. bare-metal stents for treatment of focal lesions in infrapopliteal arteries: a double-blind, multi-centre, randomized clinical trial. Eur Heart J. 2011;32:2274-2281. doi: 10.1093/eurheartj/ehr144
  8. Bosiers M, Scheinert D, Peeters P, et al. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012;55:390-398. doi: 10.1016/j.jvs.2011.07.099
  9. van Overhagen H, Nakamura M, Geraghty PJ, et al. Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries. Vasc Med. 2023;28:571-580. doi: 10.1177/1358863X231199489
  10. Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37:898-907. doi: 10.1007/s00270-014-0904-3
  11. Mustapha JA, Diaz-Sandoval LJ, Saab F. Infrapopliteal calcification patterns in critical limb ischemia: diagnostic, pathologic and therapeutic implications in the search for the endovascular holy grail. J Cardiovasc Surg (Torino). 2017;58:383-401. doi: 10.23736/S0021-9509.17.09878-0
  12. Baumann F, Fust J, Engelberger RP, et al. Early recoil after balloon angioplasty of tibial artery obstructions in patients with critical limb ischemia. J Endovasc Ther. 2014;21:44-51. doi: 10.1583/13-4486MR.1
  13. Lanzer P, Schurgers L, Twarda-Clapa A, Ferraresi R, Hui H, Kamenskiy A, et al. Medial arterial calcification in ageing and disease: current evidence and knowledge gaps. European Heart Journal. 2025;46(45):4876-4900. DOI: 10.1093/eurheartj/ehaf341
  14. Ferraresi R, Ucci A, Pizzuto A, et al.“A Novel Scoring System for Small Artery Disease and Medial Arterial Calcification Is Strongly Associated With Major Adverse Limb Events in Patients With Chronic Limb-Threatening Ischemia.”Journal of Endovascular Therapy. 2021;28(2):194-207
  15. Data on file at Reflow Medical.
  16. Mustapha JA, Ibrahim A, Saab F, et al. A novel temporary stent for treatment of infrapopliteal arteries in conjunction with drug-coated balloon angioplasty: the DEEPER pilot study. J Crit Limb Ischem. 2022;2. doi: 10.25270/jcli/CLIG22-00007
  17. Zeller T. 300.04 One-year results of the DEEPER OUS trial: the Bare Temporary Spur Stent System followed by a paclitaxel-coated balloon. J Am Coll Cardiol Intv. 2024;17(4 suppl):S33-S34
  18. Brodmann M. 300.03 One-year results of the DEEPER LIMUS trial: the Bare Temporary Spur Stent System in combination with a sirolimus-coated balloon. J Am Coll Cardiol Intv. 2024;17(4 suppl):S33
  19. Zeller T, Zhang Z, Parise H, et al. Early Tibial Vessel Recoil Following Treatment With the Bare Temporary Spur Stent System: Results From the DEEPER OUS Vessel Recoil Substudy. J Endovasc Ther. Published online September 21, 2024. doi:10.1177/15266028241280685

©2026 Reflow Medical, Inc. All rights reserved. Reflow Medical, Spur and The Pulse of Medical Ingenuity are registered trademarks or trademarks of Reflow Medical, Inc. This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Complications, and Directions for Use.

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