The Vetex Thrombectomy Catheter combines rotational and grasping action to quickly and gently remove large volumes of stubborn wall-adherent clot in a single session, without thrombolytic drugs.Vetex Medical
Vetex Medical recently completed the first-in-man case in a multicenter study of a new deep vein thrombosis (DVT) device that has the potential to reduce hospital stays and costs associated with DVT treatment.
The Galway, Ireland-based company said the Vetex Thrombectomy Catheter is the first device to combine rotational and grasping action to quickly and gently remove large volumes of stubborn wall-adherent clot in a single session, without thrombolytic drugs.
The first patient was treated by the study’s principal investigator Stephen Black, MD, Narayan Thulasidasan, MD, and their team at Guy’s and St. Thomas’ NHS Foundation Trust in London.
“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,” said Black. “This device shows the potential to start and finish the procedure in one cath lab session, avoiding ICU/HDU time and a prolonged hospital stay, and thereby saving staff time and hospital costs.”
The multicenter, non-randomized VETEX Trial is a feasibility study of 30 patients with acute iliofemoral DVT treated with the Vetex device, with the primary outcome being procedural success, defined as SIR Grade II Lysis with freedom from procedural related adverse events.
“DVT technology is not there today to deliver reliable or reproducible results every time,” said Lichtenberg. “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.”
Vetex Medical CEO Mark Bruzzi told MD+DI said the company was formed about two years ago to develop solutions for DVT that overcome the limitations of current treatment options. In particular, the company focused on a purely mechanical approach that could remove wall-to-wall clots without using thrombolytic drugs because of the associated bleeding risk.
The primary design challenge was that the device needed to be able to adapt to a range of vessel diameters in order to contact the wall of the vessel to remove the clot while also being gentle on the veins. The company put a lot of work into the project, Bruzzi said and came up with the device that is now in the early clinical trial stage. The goal of the current study is to confirm the design of the device, he added.
From there, Vetex plans to seek FDA 510(k) clearance for the device. Eventually, the company also plans to expand the patient population to include not just patients with acute DVT but also those with subacute DVT without the use of thrombolytic drugs.
Currently, anticoagulation is the most widespread therapy for DVT, Bruzzi said, but interventional treatment has demonstrated the potential for better outcomes in some patients. Interventional DVT options on the market today include the use of thrombolytic drugs to dissolve a clot, with or without the use of a mechanical device, or purely mechanical devices that use fragmentation and/or aspiration to create a core through the clot. Because thrombolytic agents thin the blood, they present a bleeding risk for many patients and can require prolonged hospital stays. Without effective treatment, up to 50% of patients with symptomatic DVT will develop post-thrombotic syndrome within two years, which involves chronic limb pain, swelling, heaviness, fatigue, and in extreme instances, limb ulceration.
“We intend to introduce more predictability and reliability to DVT treatment by paving the way to single session DVT treatment without thrombolytics,” Bruzzi said. “By integrating technologies in order to remove clot from wall to wall, we have designed our device to speed up treatment and spare the patient from thrombolytics, which has the potential to reduce complications and overall costs, and get the patient home sooner.”