One-Year Results of the DETOUR2 Trial published in the Journal of Vascular Surgery (JVS)
13 Mayo 2024 - 7:00AM
Business Wire
The DETOUR2 Trial is a prospective, single-arm, international,
multi-center clinical evaluation of the novel DETOUR™ System for
fully percutaneous femoropopliteal bypass procedures.
Endologix LLC, a privately held, global medical device company
dedicated to providing disruptive therapies for the interventional
treatment of vascular disease, has announced the online publication
of the one-year results of the DETOUR2 Trial in the Journal of
Vascular Surgery ( JVS1). The study demonstrated that the DETOUR
System offers a viable endovascular option for patients with long
segment, complex superficial femoral artery (SFA) disease.
Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR
System offers a novel approach to bypass the SFA using the vein as
a conduit. The study highlighted low rates of complications, deep
venous thrombosis (DVT), and clinically-driven target lesion
revascularization (CD-TLR), and excellent one-year primary
patency.
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DETOUR™ System Infographics. (Photo:
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"The publication of the one-year results confirms the DETOUR
System's clinical promise in treating long femoropopliteal
lesions," said Matt Thompson, MD, President, and CEO of Endologix.
"As we launch this therapy, we are committed to an extensive
training and education program that ensures the best patient
outcomes. Consistent with our evidence-based approach, further data
on the performance of the DETOUR system in real-world use will be
defined in the PTAB-1 post market study."
The DETOUR2 Study enrolled 202 patients at 32 sites, and 200
patients were treated with the DETOUR system. The mean lesion
length was 32.7 cm, 96% were chronic total occlusions (CTO), and
70% were severely calcified.
The results presented highlight:
- Freedom from CD-TLR was 87.7% through 1 year.
- Expressed as a binary end point, patency (defined as freedom
from occlusion), was 92.4% through 12 months.
- Clinical success, defined as improvement in at least one
Rutherford Category at 12 months, was 97.2%.
- Major procedure related infection within 30 days after the
index procedure was 0.5%.
- Freedom from major adverse events (MAEs) at 30 days was
93%.
- The 12-month incidence of symptomatic DVT was 4.1% with no
pulmonary emboli reported.
- Average length of hospital stay was 1.1 days.
1 Lyden SP, Soukas PA, De A, et al. DETOUR2 trial outcomes
demonstrate clinical utility of percutaneous transmural bypass for
the treatment of long segment, complex femoropopliteal disease. J
Vasc Surg. Published online February 15, 2024.
doi:10.1016/j.jvs.2024.02.004
About the DETOUR System
PTAB with the DETOUR System offers a novel approach to treating
complex PAD, enabling physicians to bypass lesions in the
superficial femoral artery, by using stents routed through the
femoral vein via a transmural passage, to restore blood flow to the
leg. This approach is effective for patients with long lesions
(20cm-46cm in length), those that have already undergone failed
endovascular procedures, or those that may be sub-optimal
candidates for open surgical bypass.
About Endologix
Endologix LLC is a California-based, global medical device
company dedicated to improving patients’ lives by providing
innovative therapies for the interventional treatment of vascular
disease. Endologix’s therapeutic portfolio includes a variety of
products in various stages of development that are designed to
treat diseases that currently have clinically relevant unmet needs.
Endologix’s commercial products, including the AFX®2 Endovascular
AAA System, ALTO® Abdominal Stent Graft System, and the DETOUR™
System, are designed to treat a range of vascular diseases, from
abdominal aortic aneurysms to lower limb peripheral vascular
disease. Endologix is wholly owned by Deerfield Management, an
investment management firm committed to advancing healthcare
through investment, information, and philanthropy. The company has
offices and manufacturing sites in Irvine, Milpitas and Santa Rosa,
California. To learn more about Endologix, please visit
https://www.endologix.com/.
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Endologix LLC Sandy Prietto 949-595-7240
sprietto@endologix.com