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
Risk Factors
Diabetes
Smoking
Advanced Age
High Cholesterol
Signs & Symptoms
Heaviness, cramping, or pain in the leg muscles after walking
Pain in your legs or feet while resting
Cold legs, feet, or toes
Sores, wounds, or ulcers on the legs, feet, or toes that are slow to heal
Current vascular interventions have typically shown
sub-optimal outcomes for patients with long complex SFA disease.
Endovascular
Interventions:
1 in 4
patients will need reintervention at one year5
Open
Surgical Bypass:
5.7
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
from CD-TLR10
100% Occlusion11
At 30 days
MAE9
Rate11
Length of Stay 1.1 Days11
CD-TLR: Clinically Driven Target Lesion Revascularization
MAE: Major Adverse Events
Contact Us:
I want to explore further:
- 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.
CONTRAINDICATIONS:
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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