The LimFlow therapy is an investigational, minimally-invasive treatment designed to divert blood flow around blocked arteries, through veins in the lower leg, and into the foot. It is being studied in the PROMISE II clinical study.

The LimFlow system is currently investigational in the U.S.; only participants in the PROMISE II clinical study are eligible to receive the treatment at this time.

LimFlow therapy is a minimally-invasive procedure involving catheters, stents and a unique device that disables valves in the vein so that blood can flow down to the foot.

Up to 120 patients are expected to participate in the PROMISE II clinical study.

Patients participating in the PROMISE II study will have follow-up doctor’s visits and tests for three years following treatment.

Your participation in the clinical study is voluntary, and you may withdraw at any time. However, your participation in the study will provide additional information on the performance of LimFlow therapy, which may prove beneficial to you and other patients in the future.

For more information on the PROMISE II clinical study, please call (888) 478-7705 or promise@limflow.com.

If you fit the preliminary criteria for potential candidates in the study, you can click here to learn more or call (888) 478-7705 for more information.

Each patient enrolled in the study will be asked to sign an Informed Consent document explaining the procedure along with risks and potential benefits. You will be asked to complete various tests to confirm your eligibility for the study prior to having the procedure. You will also be asked to come back for follow-up visits and tests for the next three years.

During this follow-up period, subjects will be assessed at different timepoints, post-procedure. These assessments are measures of safety and effectiveness and will be performed at 14 days, 30 days, at 2, 3, 6 and 9 months, at 1 year, 2 years and 3 years post-procedure.

During the visits, your doctor may perform an examination, collect imaging scans and perform other tests they deem necessary to monitor your treatment. The follow-up tests and evaluations outlined in this study are standard routine exams.

Your name or other identifying information will be protected and will not be recorded in study documents. Instead, a unique subject identifier will be assigned to record information.

There are no direct benefits guaranteed to you as a result of participating in this study. However, possible benefits include the potential for improved blood flow to the foot and the possibility of wound healing.

The study may also produce other unexpected risks and benefits. Any new and significant information or findings will be provided to you by your doctor. In addition, if the treatment is found to be effective, this will lead to improved treatment for patients who have a condition similar to yours.

Yes. As with any medical procedure, there are risks associated with doing this procedure. The most common risks are listed below. A more detailed list is provided as part of the Informed Consent document you will sign in order to participate in the study. You may also speak with your doctor if you have any questions about these risks.

• Edema of the legs, which is swelling at the area which was previously not receiving blood flow and is now receiving it
• Allergic reaction, including anaphylactic shock and allergic swelling
• Vascular complications at access site, including bleeding events and hematoma
• Events that may be related to blood clots
• Contrast-induced nephropathy and renal failure (kidney damage)
• Infection
• Pain
• If problems occur, it may result in the need for additional procedures, surgery, or amputation

The sponsor, LimFlow, Inc., will reimburse the hospital for the cost of activities performed in connection with this study. There are no additional costs to the patient associated with participation in this study.

Your participation is voluntary, and you may withdraw at any time. While no benefit from your participation can be guaranteed, your involvement in the study may provide additional information on the performance of the LimFlow System, which may prove beneficial to you and to future patients.