Technology | Venous Therapies | May 06, 2019

FDA Clears Boston Scientific Vici Venous Stent to Treat Deep Venous Blockages

Illustration showing the self-expanding deployment of the Boston Scientific Vici venous stent in the iliofemoral vein.

Illustration showing the self-expanding deployment of the Vici stent in the iliofemoral vein. 

The U.S Food and Drug Administration (FDA) has cleared the Boston Scientific Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. These blockages occur when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies.
Illustration showing the self-expanding deployment of the Boston Scientific Vici venous stent in the iliofemoral vein.

May 6, 2019 — The U.S Food and Drug Administration (FDA) has cleared the Boston Scientific Vici Venous Stent System for the treatment of iliofemoral venous obstructive disease. These blockages occur when the flow of blood through the veins located deep in the pelvic region becomes blocked by a blood clot or compressed by anatomical anomalies.

The self-expanding, nitinol stent is specifically designed to meet the challenges of venous anatomy. It uses a unique closed-cell geometry that offers high radial strength to prop vessels open in a circular lumen without compromising flexibility or deployment accuracy.

Venous obstructive disease affects nearly 40 percent of the population in the U.S. and can be caused by conditions such as deep vein thrombosis (DVT), post-thrombotic syndrome (PTS) and compressive diseases such as May-Thurner syndrome. In patients with venous obstructions, blood may pool in the legs, resulting in pain, swelling and skin ulcers.

Endovascular treatment for venous obstructive disease is focused on restoring the normal flow of blood from the legs back to the heart. The iliofemoral veins are located deep in the pelvis and may be subject to significant crushing forces from other anatomical structures such as the right common iliac artery. To help solve for this, the Vici stent system was specifically designed to be uniformly strong and crush resistant, capable of restoring blood blow by creating a cylindrical, patent vessel.

"For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimized for the disease," said Mahmood Razavi, M.D., St. Joseph Hospital, Orange, Calif. "With the approval of the Vici stent, clinicians now have access to a stent that was purposely developed and engineered to resist the vessel compression and anatomical tortuosity commonly found within the iliofemoral venous system, enabling our ability to deliver best outcomes for our patients."  

FDA Approval Based on the VIRTUS study

The approval of the Vici stent was based on data from the VIRTUS study, a prospective, multi-center, single-arm study with 170 patients. The VIRTUS study evaluated the Vici stent in relation to pre-defined objective performance goals in patients with a clinically significant obstruction in the illiofemoral venous outflow tract. It successfully met its primary safety and effectiveness endpoints.

"The FDA approval of the Vici venous stent system is the latest example of our commitment to building the most comprehensive portfolio of technologies specifically developed to meet the needs of physicians treating both chronic and acute venous disease," said Jeff Mirviss, senior vice president and president, peripheral interventions, Boston Scientific. "We are pleased to provide this differentiated stent system to U.S. patients suffering from debilitating deep venous disease."      

The Vici stent system received CE mark in 2013. The device was developed by Veniti Inc., which Boston Scientific acquired in August of 2018.

View videos on how the stent works and interviews with a patient and Razavi.

 

Related Content:

Boston Scientific to Acquire Veniti Inc.

Veniti Announces Boston Scientific Distribution Agreement for Vici Venous Stent

First U.S. Patients Enrolled in Virtus Trial for Venous Stenting

First Uses of Veniti Vici Venous Stent System Reported

Veniti Completes First Use of Novel Venous Stent System

Boston Scientific Invests $25 Million in Veniti Venous Stent

Late-Breaking Endovascular Clinical Trial Results Announced At VIVA 16

Related Content

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Overlay Init