First-in-Human Study Begins for Vetex Thrombectomy Catheter to Treat DVT
December 18, 2018—Vetex Medical Ltd. announced that the first patient has been treated in the VETEX trial, a first-in-human evaluation of venous thrombus extraction with the company's Vetex thrombectomy catheter. The Vetex device combines rotational and grasping action to remove large volumes of wall-adherent clot in a single session, without use of thrombolytic drugs.
According to the company, the VETEX study's primary outcome is procedural success, defined as Society of Interventional Radiology grade II lysis with freedom from procedure-related adverse events. The multicenter, nonrandomized feasibility study will be composed of 30 patients with acute iliofemoral deep vein thrombosis (DVT) treated with the Vetex device.
The first patient was treated by the study’s Principal Investigator Stephen Black, MD, along with Narayan Thulasidasan, MD, and their team at Guy’s and St. Thomas’ NHS Foundation Trust in London, United Kingdom.
In the company's announcement, Mr. Black commented, “The Vetex device was surprisingly effective at removing wall-adherent clot on the first pass and was easy to use in our first procedure. Existing devices can remove fresh thrombus but have difficulty creating a larger lumen through more organized material on the vessel wall. This device shows the potential to start and finish the procedure in one cath lab session, avoiding intensive care unit/high dependency unit time and a prolonged hospital stay, and thereby saving staff time and hospital costs.”
Study investigator Michael Lichtenberg, MD, of Klinikum Hochsauerland in Arnsberg, Germany, added, “DVT technology is not there today to deliver reliable or reproducible results every time. As physicians, our goal is to evolve treatment to be safer for patients, faster and more cost effective, and the Vetex device shows the potential to deliver all three.”
The Vetex thrombectomy catheter combines two minimally invasive technologies: an extraction screw and a basket. The extraction screw within the basket gently but effectively removes a large volume of wall-adherent clot without thrombolytic drugs. The basket grasps and disrupts adherent clot from wall to wall, while the rotational action of the screw pulls the clot out of the body. The device is low profile and adapts to vessel diameter, exerting predictable radial force on both large- and small-diameter veins, stated the company.