Boston Scientific gets USFDA approval for VICI VENOUS STENT System

The approval of the VICI VENOUS STENT was based on data from the VIRTUS study, a prospective, multi-centre, single-arm study with 170 patients.

New Delhi: Boston Scientific recently announced that the U.S Food and Drug Administration (USFDA) has approved the VICI VENOUS STENT System for the treatment of iliofemoral venous obstructive disease, which occurs 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 venous obstructive disease affects nearly 40 per cent of the population 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 the 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.

Commenting on the same, Dr Mahmood Razavi, St. Joseph Hospital, Orange, California said, "For those suffering from venous obstructive disease, their quality of life may suffer without treatment options optimized for the disease."

"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, " Razavi added.

The approval of the VICI stent was based on data from the VIRTUS study, a prospective, multi-centre, 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 iliofemoral 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.

Speaking to Medical Dialogues, the local authority could not provide the definite plan and projections for this device in the stent to reach Indian market and Indian consumers.