This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: DETOUR System
PMA Applicant: Endologix, LLC
Address: 2 Musick, Irvine, CA 92618
Approval Date: June 7, 2023
Approval Letter: Approval Order
What is it?
The DETOUR System is intended to treat narrowed or blocked arteries that carry blood to the knee and lower leg (superficial femoral and popliteal arteries). It consists of three components:
- A small, spiral tube (stent) made of metal (nitinol) enclosed in a polymer (ePTFE)
- A delivery catheter
- A crossing tool that helps guide the delivery catheter and covered stent to the correct position
How does it work?
- The crossing tool is inserted into a blood vessel in the groin and advanced through the vessel to the narrowed or blocked section of the superficial femoral or popliteal artery. The tool advances a needle and wire into a vein near the blockage.
- This is repeated from the lower side of the narrowed section of the artery. The guidewire then extends from above the narrowing or blockage in the artery, through the vein, and back into the artery below the narrowed area.
- The delivery catheter passes the covered stent from the artery above the blockage through the nearby vein and then returns it to the artery below the blockage.
- Once the delivery catheter is positioned in the narrowed artery, the covered stent is released and expands to form a tube. Additional covered stents can be overlapped to extend across the narrowed or blocked artery.
- The delivery catheter is removed.
- The expanded, covered stent remains permanently implanted within the artery and vein allowing blood flow around the area of blockage to the lower leg.
When is it used?
The DETOUR System is used in people who have narrowing or a blockage in the superficial femoral and popliteal arteries and who are not good candidates for surgical repair. The narrowing is caused by atherosclerosis, the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries. The DETOUR System and its components are not for use in the blood vessels of the heart (coronary) or brain (cerebral).
What will it accomplish?
In a clinical study of 220 people who were treated with the DETOUR System for narrowed or blocked femoropopliteal arteries, approximately 149 patients (68.1%) still had an open artery after one year.
When should it not be used?
The DETOUR System should not be used in people who have:
- A distal common femoral artery that is too narrow (<7 mm in diameter).
- Increased risk of a blood clot in the deep veins of the body (deep vein thrombosis).
- Blocked arteries above or below the femoropopliteal arteries.
- Bleeding disorders or who cannot take recommended medicines that thin the blood and prevent blood clots (anti-coagulants).
- Known hypersensitivities, allergies, or other reasons they cannot be exposed to nitinol, PTFE, aspirin, or heparin.