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  6. Duo Venous Stent System – P230021
  1. Recently-Approved Devices

Duo Venous Stent System – P230021

 

Duo Hybrid Stent (top) and Duo Extend Stent (bottom).

 

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: Duo Venous Stent System
PMA Applicant: Vesper Medical, Inc. 
Address: 1285 Drummers Lane Suite 105, Wayne PA 19087
Approval Date:   December 26, 2023
Approval Letter: Approval Order

What is it?

The Duo Venous Stent System is intended to treat narrowing of or reduced blood flow through the deep veins in the groin (iliofemoral veins). The Duo Venous Stent System has two parts: a small hollow tube (stent) made of a metal called nitinol and a delivery catheter. The Duo Venous Stent System includes two types of stents, the Duo Hybrid Stent and the Duo Extend Stent.

How does it work?

  • A doctor inserts the Duo Venous Stent System’s delivery catheter into a blood vessel in the groin.
  • The stent is then positioned at the narrowed section of the iliofemoral vein using the delivery catheter.
  • After the catheter is in the right place, the stent opens automatically as it is released from the delivery system.
  • The delivery catheter, without the stent, is removed.
  • The stent stays in the vein permanently, supporting the newly opened section of the vessel and increasing blood flow by preventing the vein from narrowing.

When is it used?

The Duo Venous Stent System is used to reopen parts of the iliofemoral veins that have narrowed after a blockage prevents blood flow (venous outflow obstruction). Limited blood flow in the iliofemoral veins may lead to swelling of the leg and pain when walking.

What will it accomplish?

The Duo Venous Stent System holds open the narrowed veins and improves blood flow from the leg. In a clinical study of 162 people with venous outflow obstruction, 146 people (90% of the people) still had open veins 1-year after treatment.

When should it not be used?

The Duo Venous Stent System should not be used for people who:

  • Have a known allergy or hypersensitivity to nickel-titanium alloy (nitinol)
  • Are unable to receive standard medication used for catheter-based (interventional) procedures including blood thinners (anticoagulants), contrast agents and antiplatelet therapy
  • Have vessel narrowing that prevents a balloon dilation catheter from inflating or will prevent proper stent delivery or placement
  • Have significantly twisted blood vessel structures (vascular anatomy) that may prevent safe delivery of the stent to the right location
  • For Duo Hybrid stent only: when the delivery system needs to be inserted through the blood vessel above the collarbone (jugular) or through vessels on the opposite side of the body (contralateral vascular access)

Additional information (including warnings, precautions, and adverse events):

 

 
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