Navigation Links
Medical societies to launch large-scale study on vein filter use

FAIRFAX, Va.The Society of Interventional Radiology and Society for Vascular Surgery jointly will launch PRESERVEthe first large-scale, multispecialty prospective study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment.

The studyalong with the formation of the IVC Filter Study Group Foundationare direct actions taken to address the August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients. SIR and SVS are in the process of determining a framework for the PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, with the goal of obtaining a functional view of all filters placed in the United States.

"PRESERVE data will allow a systematic, functional view, representative of all filters placed in the United States, thus, all stakeholdersindividuals, health care professionals, insurers and government regulatorswill be armed with the knowledge they need on patient risk and, subsequently, quality improvement in filter placement, management and retrieval," said SIR President Marshall E. Hicks, M.D., FSIR.

"This is a paradigm-shifting initiative: interventional radiologists and vascular surgeons collaborating to launch a large-scale prospective study evaluating inferior vena cava filters reveals a lot about each specialty's focusand that focus is on patients, first and foremost," noted SVS President Peter Gloviczki, M.D.

The five-year study will evaluate the overall safety and efficacy of filters placed by doctors and intends to enroll 1,800 patients at approximately 50 centers in the United States. Members of the IVC Filter Study Group Foundation collectively discussed ways to respond to the FDA's stated concerns. SIR and SVS are in the process of making a final decision for a contract research organization, completing protocol development and submitting the study for investigational device exemption (IDE) study with HIPAA (Health Insurance Portability and Accountability Act) compliance. Study directors are Matthew S. Johnson, M.D., FSIR, Indiana University School of Medicine, Indianapolis, Ind., and David L. Gillespie M.D., FACS, University of Rochester School of Medicine and Dentistry, Rochester, N.Y. Most filter manufacturers have agreed to participate in the study.

According to the U.S. Surgeon General, between 350,000 and 600,000 people each year in the United States are affected by blood clots and between 100,000 and 180,000 people die of pulmonary embolism (a blood clot that travels to the lungs) each year. IVC filters are placed inside patients by vascular specialists to prevent blood clots from breaking free and traveling to the lungs or heart and causing a pulmonary embolism. FDA recommendations are that physicians remove the filters, which are designed to be retrievable, once the threat of pulmonary embolism has passed. The FDA warning said that all physicians were encouraged to consider the benefits and health risks of IVC filter removal for each patient.

Members of the IVC Filter Study Group Foundation board of directors are SVS President Peter Gloviczki, M.D., Mayo Clinic College of Medicine, Rochester, Minn. (president); SIR President Marshall E. Hicks, M.D., FSIR, University of Texas MD Anderson Cancer Center, Houston (vice president); SVS Executive Director Rebecca M. Maron, CAE (secretary); SIR Executive Director Susan E. Sedory Holzer, MA, CAE (treasurer); John A. Kaufman, M.D., MS, FSIR, Dotter Interventional Institute, Portland, Ore. (SIR representative); and Peter Lawrence, M.D., UCLA Medical Center, Santa Monica (SVS representative).


Contact: Ellen Acconcia
Society of Interventional Radiology

Related biology news :

1. Alnylam and UMass Medical School announce Tuschl I patent upheld in European opposition proceedings
2. Miniature pressure sensors for medical touch
3. Research!America says house funding levels for FY13 could undermine medical progress
4. Mainz University Medical Center attracts funding of Alexander von Humboldt Professorship
5. Medical device, health professionals attend first national conference on value-driven engineering
6. Ultrasensitive biosensor promising for medical diagnostics
7. UH Case Medical Center, CardioKinetix reveal promising data for treatment for heart failure
8. Tufts Medical Center researchers finds marker in premies saliva predicts readiness to feed by mouth
9. CDS Monarch Deploys DigitalPersona Strong Authentication Solutions for Secure Access to Electronic Medical Records
10. Nuisance seaweed found to produce compounds with biomedical potential
11. MADRID-MIT M+Vision Consortium hosts Biomedical Innovation Conference 2012
Post Your Comments:
(Date:10/8/2015)... , October 8, 2015 ... or the "Company"), a biometric authentication company focused ... of the Wocket® smart wallet announces that revenues ... were approximately $410,000 compared with $113,00 for the ... the 9 months ended September 30, 2015 were ...
(Date:10/5/2015)... 2015 ) ... Inc. (NASDAQ: NXTD ), a biometric authentication company ... ) releases the following market ... ), a biometric authentication company focused on the growing ... ( ) releases the following market ...
(Date:9/30/2015)... YORK , Sept. 30, 2015  The global glucose ... billion for 2015. So says a new report on the ... diabetes management segment dominate the market, followed by continuous glucose ... publisher. Kalorama reports on the market for these products in its ... ...
Breaking Biology News(10 mins):
(Date:10/13/2015)... Mass. and TORONTO , Oct. ... GNBT) today announced that it has entered into a non-binding ... ), a private Israeli company that has developed a proprietary ... infertile due to varicoceles. the United States ... between the ages of 25 and 44 diagnosed ...
(Date:10/13/2015)... ... October 13, 2015 , ... Proove ... to announce their partnership with the Keck Medicine of the University of ... , The T.R.O.J.A.N. Study (Therapeutic Evaluation to Research Clinical Objectives Linking Genotypic and ...
(Date:10/12/2015)... ... ... Spirax Sarco, the leader in products and services for steam system solutions ... generator . This unit is a skid mounted system that is designed to ... The CMS-C 600 generator can produce up to a maximum of 1,275 lb./hr. ...
(Date:10/12/2015)... , October 12, 2015 cell surface ... billion by 2022, according to a new report by Grand ... to rise in incidence of oncology diseases and other cell-associated ... is expected to reach USD 6.49 billion by 2022, according ... growth in demand can be attributed to rise in incidence ...
Breaking Biology Technology: