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PROMISE II – U.S. Pivotal Study

12 Month Study Results1

PROMISE II is a landmark multi-center, prospective pivotal study of the LimFlow System conducted at 20 U.S. centers in 105 No-option CLTI patients typically excluded from other clinical studies. All patients were confirmed as “No-Option” and facing imminent amputation by an independent review committee of vascular surgeons. Patients were enrolled between December 2020 to March 2022. This study was a success and met its primary endpoint.

Patient Demographics

105 Patients

“Sickest population of CLTI patients ever enrolled in a pivotal trial.”

– Dr. Dan Clair, PROMISE II Co-PI

PROMISE II - Demographics | amCharts

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Ineligible for endovascular or surgical procedures to restore blood flow
Stable dialysis allowed
Rutherford class 5 and 6
99% technical success

Limb Salvage at 12 Months

Functional Limb Preservation in No-Option Patients

Wounds Healed or Healing at 12 Months

Wound Healing in Patients With Non-Healing Chronic Wounds

12M Pain Resolution and Rutherford Class Improvement

Pain Resolution (0-10 Scale)

Pain Resolution (0-10 Scale)

Rutherford Classification Improvement

Rutherford Classification Improvement

At 12 months, over half presented as Rutherford 0

Participating Sites:

Baylor College of MedicineSanger Heart & Vascular Institute
Boston Medical CenterSeton Heart Institute
Coastal Carolina SurgeryThe Cardiac and Vascular Institute
Dartmouth – Hitchcock Medical CenterUH Cleveland Medical Center
Harbor-UCLA Medical CenterUnityPoint Health
Mass General HospitalUniversity of California San Francisco
Ochsner Health CenterUniversity of Florida
Ponce Health Sciences UniversityVanderbilt University Medical Center
Prisma Health Upstate and MidlandsYale University
Saint Luke's Hospital of Kansas City

Thank you to all the investigators for your tremendous contribution to the PROMISE II pivotal trial.

Watch interview with Dan Clair, MD and Mehdi H. Shishehbor, DO, MPH, PhD

1. Clair DG (2023, October 30 – November 2). PROMISE II Update: 1 Year Results [Conference presentation]. VIVA 2023. Las Vegas, NV, United States