Endologix Announces Results of Pooled Analysis of DETOUR1 and DETOUR2 Studies at 2023 VIVA Late-Breaking Clinical Trial Session

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Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System.

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星期四, 十一月 2, 2023
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Health, Medical Devices, Health Technology, Clinical Trials, Research, Science, Cardiology, Maes, Length of stay, Vascular disease, SFA, Physician, MD, Safety, Cleveland, Arnold, Leg, PE, DVT, Femoral vein, Freedom, VIVA, TVR, PTAB, Patient, PAD, Medical imaging, Airline
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摘要
Key Points: 
  • Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System.
  • For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).
  • “We are pleased to present the combined results of the DETOUR1 and DETOUR2 Studies.
  • Safety and Performance of percutaneous Transmural Femoropopliteal Bypass with the DETOUR System: Pooled analysis of DETOUR1 and DETOUR2.


Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced results from a pooled analysis of DETOUR1 and DETOUR2 Studies evaluating Percutaneous Transmural Arterial Bypass (PTAB) with 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 conduits 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).

Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multi-center, international studies designed to evaluate the DETOUR System. Inclusion criteria and pre-specified endpoints were similar. Both studies utilized imaging core lab and independent adverse event adjudication. Endpoints included freedom from MAEs through 30 days, symptomatic DVT, and length of stay. For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).

The results from the 275 pooled patients were presented at the 2023 VIVA Late-Breaking Clinical Trial Session by one of the study’s principal investigators, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.

The presented results* included the following:

  • Primary patency, defined as freedom from TVR, was 79.1% at 1-year and 68.1% through 2 years.
  • Freedom from MAEs through 30 days was 97.8%.
  • Clinical success rate was 92.9%, 96.0%, and 95.3% at 30 days, 1 year and 2 years, respectively.
  • Symptomatic DVT was 3.3% and PE rate was 0%, respectively through the 2-year time point.
  • Average length of hospital stay was 1.3 days.
  • Ninety-four percent of the patients (94%) had chronic total occlusions of the SFA, with a mean lesion length of 31.6cm.

"These results not only demonstrate the clinical utility of this therapeutic strategy in managing long complex femoropopliteal lesions but also highlight that PTAB with the DETOUR System achieves similar results to open surgical prosthetic femoropopliteal bypass without the need for general anesthesia, long length of stay, and high rate of complications. We eagerly await more comprehensive data from broader real-world settings to further corroborate these findings,” stated Dr. Lyden.

“We are pleased to present the combined results of the DETOUR1 and DETOUR2 Studies. The data are congruent between the studies and strengthen our confidence in the transformative potential of the DETOUR System,” said Matt Thompson, MD, President, and CEO of Endologix. “The DETOUR System offers a compelling alternative for addressing long, complex femoropopliteal lesions. As we look ahead, we are eager to bring PTAB using the DETOUR System to patients with complex PAD.”

*Lyden et al. Safety and Performance of percutaneous Transmural Femoropopliteal Bypass with the DETOUR System: Pooled analysis of DETOUR1 and DETOUR2. VIVA 2023

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/.

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 products are available in every country. Please consult with your Endologix representative to confirm product availability.

©2023 Endologix LLC. All rights reserved.

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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