PAD

Patients with long
complex SFA disease

face treatment tradeoffs,

and some have no desirable options.^1-3

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.

**long lesion defined as 20 to 46 cm

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

days in hospital on average⁶

4.5 - 14%

infection rate post surgery^5,7-8,12

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

0 %

Freedom
from CD-TLR¹⁰

0 %

Freedom from
100% Occlusion¹¹

At 30 days

0 %

Freedom from
MAE⁹

0 %

Infection
Rate¹¹

Length of Stay 1.1 Days¹¹

Read clinical evidence

CD-TLR: Clinically Driven Target Lesion Revascularization
MAE: Major Adverse Events

The DETOUR System is comprised of two main components:

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REFERENCES

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.

Legal Information:

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.