News | Peripheral Artery Disease (PAD) | August 02, 2017

LimFlow Reports Positive Data in Pilot Study of Percutaneous Deep Vein Arterialization System

Technology converts veins into arteries to eliminate critical limb ischemia caused by advanced peripheral artery disease (PAD)

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI).

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI). This image shows how the covered stents used with the system connect to create a new arterial pathway.

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) Valvutome device

The LimFlow system's valvutome device.

Aug. 1, 2017 — LimFlow SA announced publication of positive results from the pilot study of the LimFlow Percutaneous Deep Vein Arterialization System (pDVA) in the July issue of the Journal of Endovascular Therapy. The paper is entitled “Midterm Outcomes from a Pilot Study of Percutaneous Deep Vein Arterialization for the Treatment of No-Option Critical Limb Ischemia.” The LimFlow System is a novel, percutaneous device for the treatment of end-stage critical limb ischemia (CLI) when all other revascularization efforts have been exhausted.

The LimFlow System is designed to restore perfusion to the ischemic foot, which may relieve rest pain, promote chronic wound healing, reduce major amputations and restore mobility for patients when used as part of a multi-disciplinary team approach. It uses proprietary ultrasound-guided catheters and covered nitinol stents to uniquely bypass diseased arteries and divert blood flow into the tibial vein to vascularize the ischemic foot. 

The authors conclude that, “pDVA is an innovative approach for treating no-option CLI and represents an alternative option for the ‘desert foot,’ potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort.”

The prospective, open-label, single-arm pilot study was led by primary investigator Steven Kum, M.D., of Changi General Hospital, Singapore, and encompassed seven no-option CLI patients with an average age of 85. All patients had diabetes and were Rutherford Class 5 or 6, with 86 percent (6 of 7) also classified as WIfI (Wound Ischemia foot Infection) “high risk”.
 
All primary safety endpoints were met in 100 percent of patients, with no deaths, above-the-ankle amputations or major re-interventions at 30 days. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. The technical success rate was 100 percent.
 
At six months, 86 percent of patients (6 of 7) had avoided major amputation, and at 12 months 71 percent of patients (5 of 7) had done so. Complete wound healing was achieved in 57 percent of patients (4 of 7) at six months and in 71 percent of patients (5 of 7) at 12 months. The median healing time was 4.6 months.
 
Perfusion rose dramatically in the LimFlow patients, from 8 mmHG pre-procedure to 59 mmHG (p=0.080) at the time of healing.
 
The authors commented that, “The immediate angiographic appearance was dramatic. One patient who had prior lumbar sympathectomy and was on high doses of opioids for chronic pain had a dramatic resolution of her pain within 48 hours and was opioid free.”
 
There were two instances of myocardial infarction within 30 days, each with minor clinical consequences. Three patients died of causes unrelated to the procedure or device at six, seven, and eight months, respectively.
 
“It is our mission to reduce the incidence of amputation, resolve pain and promote wound healing in a previously hopeless patient population and we are very encouraged by the early promising results of the LimFlow System,” said LimFlow CEO Dan Rose. “The high technical success rate also demonstrates that our novel concept of percutaneous and minimally-invasive bypass below the knee is an achievable and reproducible technique. We look forward to the results from our U.S. feasibility study, which is currently enrolling, and our international post-market, multi-center study outside of the U.S. to validate these early findings.”
 
The LimFlow System received the CE mark in October 2016 and is currently available commercially in Europe. The LimFlow System is only available for investigational use in the U.S. and has not been approved for sale in the USA, Canada or Japan.

Watch the VIDEO “State of Therapy for Critical Limb Ischemia,” an interview with Michael Jaff, M.D., medical director of Massachusetts General Hospital’s Fireman Vascular Center. 

For more information: www.limflow.com

Related Content

TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
htisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...