PTAB with the DETOUR System featured in EVT
complex SFA disease
Introducing PTAB the first-ever fully percutaneous transmural arterial bypass (PTAB) therapy using the DETOUR™ System
PTAB with the DETOUR system introduces a novel alternative to open surgical bypass for patients with PAD. It is the first procedure that effectively bypasses long** femoropopliteal lesions.
Be one of the first to try PTAB with the DETOUR System
In the US, approximately 8.5 million adults have lower extremity PAD.5
Signs & Symptoms
Current vascular interventions have typically shown
sub-optimal outcomes for patients with long complex SFA disease.
1 in 4
patients will need reintervention at one year5
4.5 - 14%
Now, PTAB with the DETOUR System offers patients with PAD an alternative treatment option with comparable outcomes to surgical bypass while avoiding its complications.
DETOUR2 Study results demonstrated:
At 1 year
At 30 days
Length of Stay 1.1 Days11
CD-TLR: Clinically Driven Target Lesion Revascularization
MAE: Major Adverse Events
The DETOUR System is comprised of two main components:
- J Mustapha and G Halena. Percutaneous femoropopliteal bypass—the DETOUR I trial. Charing Cross 2018 Book Chapter Vascular and Endovascular Controversies Update.
- Cassese S, Ndrepepa G, Liistro F, et al. Drug-coated balloons for revascularization of infrapopliteal arteries: a metaanalysis of randomized trials. JACC Cardiovasc Interv. 2016;9:1072-1080
- van de Weijer et al. Seminars in Vasc Surg 2015 June; 28(2): 112-21. Morbidity of fempop surgery. https://doi.org/10.1053/j.semvascsurg.2015.09.004
- AHA Statistical Update. Heart Disease and Stroke Statistics—2022 Update: Summary. Circulation.2022;145:e153–e639. DOI: 10.1161/CIR.0000000000001052
- Kim TI, Zhang Y, Cardella JA, Guzman RJ, Ochoa Chaar CI. Outcomes of bypass and endovascular interventions for advanced femoropopliteal disease in patients with premature peripheral artery disease. J Vasc Surg. 2021 Dec;74(6):1968-1977.e3. doi: 10.1016/j.jvs.2021.05.034. Epub 2021 Jun 6. PMID: 34090986.
- Medicare open surgical bypass procedures based on 2021 data
- Shah, T, Tirziu, D, Ghare MI, Yang Y, Taoutel R, Gaston, S, Pietras C, Lansky AJ. Surgical Bypass of Femoral-Popliteal Arterial Disease: A Meta-analysis of Randomized and Prospective Trials. J CRIT LIMB ISCHEM 2022;2(4):E122-E130
- Voicu S, Trooboff SW, Goodney PP, Zwolak RM, Powell RJ. Medicare reimbursement of lower extremity bypass does not cover cost of care for most patients with critical limb ischemia. J Vasc Surg. 2020 Sep;72(3):1068-1074. doi: 10.1016/j.jvs.2020.01.062. PMID: 32829764
- Lyden. Percutaneous Bypass for Treatment of Long-Segment Femoropopliteal Disease: 12 Month Results from the DETOUR 2 Trial Volume 75, Issue 6, E337-E338, June 2022
- P220021 Summary of Safety and Effectiveness Data (SSED). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
- Lyden et al. Durability of Percutaneous Bypass for Treatment of Femoropopliteal Disease: Two-year Outcomes of the DETOUR-2 Study. VAM 2023
- Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5. PMID: 16325694.
INDICATIONS FOR USE:
The DETOUR™ System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200mm to 460mm in length with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR™ System, or any of its components, is not for use in the coronary and cerebral vasculature.
The DETOUR™ System is contraindicated in patients with:
- A distal common femoral artery (CFA) <7 mm in diameter.
- Increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy.
- Untreated flow-limiting aortoiliac occlusive disease.
- Lack of patent single vessel tibial runoff to ankle.
- Known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed.
- Known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed.
Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE: Not all product components are available in every country.
Please consult with your Endologix representative to confirm product availability.
Endologix® is a registered trademark of Endologix LLC in the United States, Europe and Japan. All other trademarks are the property of their respective owners.
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