Boston Scientific Announces FDA Approval of VICI Venous Stent System for Iliofemoral Venous Obstructive Disease

VCBeat (WeChat ID: vcbeat) has learned that on May 6, medical device company Boston Scientific announced that its VICI Venous Stent System had received FDA approval for the treatment of iliofemoral venous obstructive disease.

It is reported that 40% of Americans suffer from venous obstructive disease. When blood flow through the deep veins in the pelvic region is blocked by thrombi or compressed due to anatomical abnormalities, the body may experience symptoms such as pain, swelling, and skin ulcers. Venous obstructive disease is typically caused by compressive conditions such as deep vein thrombosis (DVT), post-thrombotic syndrome (PTS), and May-Thurner syndrome.

Endovascular therapy for venous obstructive disease primarily aims to restore normal blood flow from the legs to the heart. The iliofemoral veins, located deep within the pelvis, may be subjected to significant compressive forces from adjacent anatomical structures, such as the right common iliac artery.

To address this issue, the VICI Stent System is specifically designed with uniform strength and crush resistance to restore blood flow via a cylindrical, patented delivery system. In a single-arm trial involving 170 patients, the safety and efficacy of the VICI Stent were confirmed.

VICI Venous Stent (Image from Official Website)

The VICI Venous Stent System is a self-expanding nitinol stent specifically designed for venous anatomy. Featuring a unique closed-cell geometry, the VICI Stent offers superior resistance to compression, effectively restoring blood flow while balancing radial strength. It maintains patency and flexibility throughout the patient’s expected lifespan. Please note that this stent is a prescription-only device.

The VICI Venous Stent System is designed to improve the lumen diameter of the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. However, this device is contraindicated in patients diagnosed with venous lesions and those who cannot receive intraprocedural anticoagulation therapy. Additionally, the VICI product labeling includes a warning: the VICI stent is composed of nitinol and tantalum, which are safe for the vast majority of individuals. However, patients with allergies to these materials or a history of metal allergy may experience an allergic reaction to this device.

Dr. Mahmood Razavi of St. Joseph Hospital in Orange, California, stated, “For patients suffering from venous obstructive disease, the lack of an optimal treatment regimen can significantly impair their quality of life. The newly approved VICI stent is uniquely designed to withstand the vascular compression and anatomical distortions commonly seen in the iliofemoral venous system, thereby providing patients with optimal therapeutic outcomes.”

“FDA approval of the VICI Venous Stent System is the latest testament to our commitment to building a comprehensive technology portfolio,” said Jeff Mirviss, Senior Vice President at Boston Scientific. “We are pleased to make this stent system available to U.S. patients suffering from severe venous disease.”

Boston Scientific was founded in Marlborough, Massachusetts, in 1979 and went public on the New York Stock Exchange in May 1992. As a leading innovator in medical solutions, Boston Scientific is dedicated to improving patient health worldwide. The company’s products and technologies are primarily used to diagnose or treat a wide range of conditions, including those affecting the heart, digestive system, lungs, urological system, and chronic pain.

(Compiled by: Li Chengping)