Vetex Medical Announces First Patient Treated in FIM Study of Deep Vein Thrombosis Treatment Designed to Remove Wall-Adherent Clot in Single Session, Without Thrombolytic Drugs
GALWAY, Ireland – December 19, 2018 – Vetex™ Medical Ltd. announced that the first patient has been treated in the VETEX (Venous Thrombus Extraction) Study, a first-in-man, multicenter study of the Vetex™ Thrombectomy Catheter. The Vetex device is the first DVT device to combine rotational and grasping action to quickly and gently remove large volumes of stubborn wall-adherent clot in a single session, without use of 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, in a study that includes notable DVT treatment experts Michael Lichtenberg, MD, FESC, of Klinikum Hochsauerland GmbH in Arnsberg, Germany, and Gerry O’Sullivan, MD, University Hospital Galway, Ireland.
“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 Dr. 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 Dr. 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.”
“We intend to introduce more predictability and reliability to DVT treatment by paving the way to single session DVT treatment without thrombolytics,” said Vetex Medical CEO Mark Bruzzi. “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.”
Current DVT Treatment
While anticoagulation remains the most widespread therapy for DVT, interventional treatment has demonstrated the potential for better outcomes in select patients. Currently available interventional DVT treatment options include the use of thrombolytic drugs to dissolve 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 percent 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.
About the Vetex Thrombectomy Catheter
The Vetex Thrombectomy Catheter combines two minimally-invasive technologies – an extraction screw within a basket – to gently but effectively remove 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 gently adapts to vessel diameter, exerting predictable radial force on both large and small diameter veins.
About Vetex Medical Ltd.
Vetex Medical is a privately-held company focused on making venous clot removal predictable, quick and cost-effective. The company’s first innovation – the Vetex Thrombectomy Catheter – is the only system to treat deep vein thrombosis by combining rotational and grasping action to gently remove a large volume of clot from wall to wall in a single session, without use of thrombolytic drugs. For more information, please visit www.vetexmedical.com.