Technology | Venous Therapies | April 03, 2019

FDA Clears Venous Stent for the Iliofemoral Veins

The U.S. Food and Drug Administration (FDA) recently cleared Bard Peripheral Vascular's Venovo Venous Stent System intended to treat narrowed iliofemoral veins.

April 3, 2019 — The U.S. Food and Drug Administration (FDA) recently cleared Bard Peripheral Vascular's Venovo Venous Stent System intended to treat narrowed iliofemoral veins. 

The Venovo is used to reopen narrowed regions of iliofemoral vein caused by a collection of fibrous blood clots that can form along the lining of the veins following a deep vein thrombosis (post-thrombotic syndrome) or the squeezing of the vein between a bone and an overlying artery (iliofemoral compression). These conditions may limit blood flow from the leg and lead to swelling of the leg and pain when walking.

The FDA said in the clinical study, 88.3 percent of patients who received stents continued to have an open iliofemoral vein after one year. Moreover, statistically significant improvements in pain and quality of life were observed from baseline to 12-months.

The stent has two components, a stent made of a nickel-titanium alloy (nitinol) tubing and an over-the-wire stent delivery catheter system. The physician rotates a thumb wheel on the delivery system to expose the stent which then self-expands automatically. The stent increases blood flow from the leg by holding the iliofemoral vein wall open. 

For more information: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm633970.htm?utm_campaign=2019-03-25%20Recently%20Approved%20Devices&utm_medium=email&utm_source=Eloqua

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...