News | April 06, 2012

Vena Cava Filter Shows Success in Preventing Recurrent Pulmonary Embolism

April 6, 2012 — Crux Biomedical announced that a recently completed pivotal trial of its Crux Vena Cava Filter (VCF) System with bi-directional retrieval was presented at the 2012 Society of Interventional Radiology (SIR) Annual Scientific Meeting, March 24-29, in San Francisco. Vena cava filters are designed to trap blood clots that can lead to potentially fatal pulmonary embolisms (PE) among patients at risk. In the study, deployment and retrieval each were achieved with a 98 percent success rate.

By obstructing the blood flow through the lungs, PE cause difficulty breathing, chest pain and palpitations. Each year in the United States, approximately 600,000 patients develop PE and an estimated 200,000 deaths occur.

The primary means of prevention and therapy of PE is systemic administration of anticoagulant agents, but is contraindicated in many patients. These patients require alternate treatments to reduce the ongoing PE risk, including vena cava filters – small devices that are inserted in the inferior vena cava, the main blood vessel returning blood from the lower part of the body to the heart, to prevent blood clots from reaching the lungs.

The Crux Biomedical VCF was designed to address the limitations of currently available VCFs, including perforation, migration and inability to retrieve. "Crux designed a device that is both more versatile and simple to use," said Tom Fogarty, M.D., founder of Crux Biomedical.

“The Crux device demonstrated an excellent safety profile,” added Robert R. Mendes, M.D., principal investigator of the study. “The clinical study evaluation has demonstrated the Crux VCF System device can be used safely for the prevention of recurrent PE.”

The recently completed pivotal trial, known as the RETRIEVE Clinical Study, was a prospective, single-arm, multinational investigational study to assess the safety, performance and efficacy of the Crux VCF System as both a retrievable and a permanent device. The trial included 125 patients at high risk for PE and was performed at 22 centers in the United States, Australia, New Zealand and Belgium.

In the study, the technical success rate of filter deployment was 98 percent; filter retrieval success was also 98 percent. The average retrieval time was 7 minutes, with the femoral approach used for retrieval in 70 percent of cases. By the six-month follow up of the study (CONFIRM), no embolizations, migrations, or fractures were observed.

The presentation at the SIR 2012, titled “The Results of the Crux Vena Cava Filter RETRIEVE Trial,” was authored by Mendes and during the IVC Filters session.

For a video of the Crux being deployed, click here.

For a video of the device being retrieved, click here.

The Crux VCF has received CE Mark approval for commercial use and is being studied in the United States under an approved investigational device exemption (IDE) study.  510(k) clearance for commercial distribution in the U.S. is pending.

For more information:

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init