News | January 15, 2010

Trial Compares Catheter vs. Ultrasound-Accelerated Thrombolysis

EkoSonic catheter helps speed thrombolysis with ultrasound waves.

January 15, 2010 – A Dutch multicenter trial (DUET) is comparing ultrasound (US) accelerated catheter-directed thrombolysis to standard catheter-directed thrombolysis in patients with recently thrombosed infra-inguinal native arteries or bypass grafts.

Principle investigator Dr. Jean-Paul de Vries, St. Antonius Hospital, Nieuwegein, said the current therapy of using catheters to deliver thrombolytics to dissolve a clot is time consuming and uncomfortable for the patient. “The problem is that this process can take more than 36-48 hours during which the patient is restricted to a bed in a hospital monitoring unit and bleeding complications increase with duration of thrombolysis,” he said. “This new ultrasound-accelerated technology promises to significantly reduce the treatment time. Such a reduction, if proven, could reduce treatment costs, patient discomfort, and the risk of bleeding which is sometimes associated with these types of drugs”.

The study will use the EKOS ultrasound accelerated thrombolysis catheter system, which is expected to significantly reduce therapy time by at least 12 hours and help reduce complication rates.

The study includes 60 adult patients with recently (between one and seven weeks) thrombosed infra-inguinal native arteries or bypass grafts with acute limb ischemia class I and IIa, (according to the Rutherford classification for acute ischemia). They will be randomly allocated to either standard thrombolysis or EKOS ultrasound accelerated thrombolysis. The anticipated duration of recruitment will be one year.

The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infra-inguinal native artery or bypass graft with outflow via at least one crural artery.

The study is being supported by EKOS Corp. and its Netherlands distributor AngioCare BV.

For more information: www.ekoscorp.com

Related Content

Merit Medical Acquires Assets of Vascular Insights LLC
News | Catheters | December 18, 2018
Merit Medical Systems Inc. announced that it has acquired substantially all of the assets of Vascular Insights LLC,...
Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication
News | Catheters | October 02, 2017
October 2, 2017 — Reflow Medical Inc. announced that the company has received 510(k) clearance from the U.S.
Roxwood Medical Announces Agreement With Abbott for U.S. Product Distribution
News | Catheters | August 09, 2017
Roxwood Medical Inc. recently announced it has entered into an exclusive agreement with Abbott for distribution of...
Teleflex, FDA 510k clearance, TrapLiner Catheter, U.S. launch
Technology | Catheters | March 02, 2017
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
Merit Medical Systems, SwiftNINJA Steerable Microcatheter, FDA 510(k) clearance
Technology | Catheters | November 09, 2016
November 9, 2016 — Merit Medical Systems Inc.
VentureMed Group, Flex Scoring Catheter, FDA approval, peripheral arterial disease, PAD, endovascular treatment
Technology | Catheters | July 13, 2016
July 13, 2016 — VentureMed Group Ltd., specializing in devices for the endovascular treatment of...
Roxwood Medical, MicroCross Catheter, full U.S. launch

Image courtesy of Roxwood Medical

Technology | Catheters | January 07, 2016
Roxwood Medical Inc. reported that more than 500 patients have been successfully treated as part of the initial limited...
Overlay Init