IR UP FRONT
SIR president comments on IVC filters
by SIR President Alan H. Matsumoto, MD, FSIR
Amid the increased media and marketplace scrutiny regarding IVC filters, I want to remind our members of the society’s foremost commitment to patient safety. SIR has been engaged in ongoing dialogue with the FDA for several years to gather additional data and better understand IVC filter safety and effectiveness. To this end, the multispecialty, FDA-approved PRESERVE study is now enrolling patients to obtain a real world experience on most of the currently available IVC filters in the United States. More information can be obtained about this study at
preservetrial.com.
If you are contacted by a concerned patient, SIR offers the following resources and suggestions to determine the best course of action for your patient: consult SIR standards, including our 2011 Quality Improvement Guideline or review multiple articles published in JVIR over the last 10 years regarding IVC filter placement and removal. In addition, some IVC filter manufacturers have useful information available on their websites for patients and physicians.
SIR meets with FDA to discuss doxorubicin
powder shortage Drug manufacturer Mylan has responded to SIR’s concerns about the shortage of doxorubicin lyophilized powder (
bit.ly/1Q4G4s0). Read SIR’s original letter of concern at
bit.ly/21SHoSB.
Disappointed with Mylan’s response, SIR initiated a call with the U.S. Food and Drug Administration (FDA) Drug Shortages Office to describe the impact of this shortage on patients. FDA staff reported that they have been working with Mylan but currently have no timeline for a resolution. Please contact Tricia McClenny (tmcclenny@
sirweb.org), SIR associate executive director, if you are aware of any companies manufacturing doxorubicin powder outside the United States.
FDA staff provided a copy of their Personal Importation Policy (
bit.ly/1Q4Gizg), which may be a solution to obtain the drug in a timely manner for patients with a critical need during the shortage, if there is a supplier outside the United States who can provide the drug. SIR will continue to work with the FDA and advocate for a solution to this drug shortage.
Top 5 downloads from the SIR Connect Open Forum in 2015
1
Hypogastric block article posted by Elizabeth B. Spencer, MD, FSIR (318)
2 Reviews outcomes following moxifloxicin prep for IA interventions posted by Daniel B. Brown, MD,
FSIR (183)
3 Varicocele grade IV after surgery without reflux to testicle on angio posted by Eduardo P.
Eyheremendy, MD (79)
4 Hepatic vasular malformation posted by Stephanie A. Reddick, MD (76)
5 ACGME Application Guidelines for IR Residency posted by M. Victoria Marx, MD, FSIR (60)
12 IR QUARTERLY | WINTER 2016
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