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: LimFlow™ System
PMA Applicant: LimFlow, Inc.
Address: 3031 Tisch Way-110 Plaza West, San Jose, CA 95128
Approval Date: September 11, 2023
Approval Letter: Approval Order

What is it?

The LimFlow system allows doctors to connect an artery in the calf to a vein near the foot to restore blood flow to the feet in patients with chronic limb threatening ischemia (also known as critical limb ischemia) that are likely to have an amputation and are not good candidates for surgical bypass. The LimFlow System consists of the following components: an arterial catheter, venous catheter, valvulotome (a surgical blade), covered stent, and delivery system. The covered stent is a small hollow tube made of metal (nitinol) and covered in a polymer film. The stent and delivery system contains metallic bands that can be visualized under fluoroscopy imaging.

How does it work?

• The doctor moves the arterial and venous catheters through blood vessels in the patient’s lower limb until the catheters are next to each another.
• Once the two catheters are next to each other, the doctor uses the needle in the arterial catheter to create an opening between the artery and neighboring vein.
• A guidewire is inserted between the artery and neighboring vein to allow the doctor to also insert angioplasty balloon. The doctor will inflate the balloon to increase the size of the opening that was first created by the needle.
• The valvulotome (a surgical blade) is used to remove venous valves, which are present in all veins and must be cut to allow for a change in blood flow towards the foot.
• The stent, mounted on a delivery catheter, is inserted into the blood vessel and through the opening. Additional stents may be added to create a channel from the artery to the vein. The stent allows blood to flow from the artery into the vein to restore blood flow to the foot.

When is it used?

The LimFlow System is used to treat patients with chronic limb-threatening ischemia (also known as critical limb ischemia), which is associated with rest pain, unhealing wounds, amputation and increased mortality. Chronic limb-threatening ischemia results from a collection of fatty substances, such as cholesterol, and calcification that form “plaque” along the lining of the arteries. The plaque formation can reduce, or totally block blood flow to the lower limb, and lead to unhealing wounds in the feet.

What will it accomplish?

The covered stents create a bridge between an artery and vein that allows for blood to flow past a blocked artery into the foot. In a study of 105 subjects, the amputation-free survival was 66.1% at 6 months as estimated by Kaplan-Meir method, which is better than historical rates with currently available treatments. In subjects with evaluable images, many subjects experienced improvements in wound healing and quality of life.

When should it not be used?

The LimFlow System should not be used in the following patients:

• Patients with deep venous thrombus in the target vein.
• Patients with uncorrected bleeding disorders or who cannot receive anticoagulation (blood thinners) or antiplatelet aggregation therapy.

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

• Summary of Safety and Effectiveness Data (SSED)
• Labeling
• PMA Database entry