KISSIMMEE, Fla., The International Stroke Conference, Feb. 16 /PRNewswire/ -- The results of the National Institutes of Health (NIH)-sponsored Interventional Management of Stroke II (IMS II) trial, presented today at the International Stroke Conference in Kissimmee, Florida, support a promising new treatment for victims of ischemic stroke. Principal investigators Joseph Broderick M.D. and Thomas Tomsick M.D. of the University of Cincinnati presented data demonstrating that intra-arterial (IA) drug delivery combined with more traditional intravenous (IV) approach results in a trend toward better outcomes than treatment with IV alone in ischemic stroke patients. The EKOS(R) Micro-Infusion Catheter was used in 41 percent of the patients in the 73 patient trial to deliver the thrombolytic drugs directly to the clot. The unique EKOS product that incorporates ultrasound technology is designed to better disperse drug into the clot.
EKOS Corporation, a privately held company, is the world leader in providing ultrasound-assisted, fluid infusion catheters for diagnosis and therapy. In the trial, the EKOS Micro-Infusion catheters combined the targeted delivery of thrombolytic agents using its neuro catheter with the use of a miniaturized ultrasound transducer incorporated into the tip of the catheter to accelerate the dissolving of the blood clot.
“We are greatly encouraged by the IMS II findings presented today and the implications for the medical community and victims of ischemic stroke,” said Peter Rule, Chairman and Chief Executive Officer, EKOS Corporation. “When you look at the positive data on our peripheral system presented at the International Symposium on Endovascular Therapy (ISET) last month together with the IMS II results presented today, it’s clear that ultrasound-assisted, catheter-based therapy can positively impact the treatment of blood clots throughout the body. At EKOS, we are committed to continuing to build that body of clinical evidence so that the technology can benefit even more patients.”
EKOS’ products include both the EKOS Micro-Infusion Catheter and the EKOS Lysus(R) Peripheral Infusion System, which are cleared for use in dissolving blood clots in the periphery to treat patients with peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT). The treatment of DVT, in particular, is regarded as one of the most significant but least aggressively treated segments of the peripheral vascular diseases. While many current treatment protocols advocate the use of Low Molecular Weight Heparin to arrest additional thrombus formation, this treatment does not address pre-existing thrombus volume.
The two studies presented at the ISET using the ultrasound-enhanced drug delivery systems from EKOS showed positive results. The first demonstrated that the EKOS Lysus Peripheral system was able to dissolve 88 percent of PAO blood clots in only 17.5 hours with a minimal 1.3 percent bleeding complication rate. This is a marked improvement over results using standard catheters, which achieved only 68 percent complete dissolving of the clot in a longer time period (24.4 hours) with a higher bleeding rate (12.5 percent). Further, the results of the EKOS system in the treatment of DVT demonstrated complete clearing of 70 percent of the clots in 23.3 hours with only a 5.5 percent bleeding complication rate. The combined results are particularly encouraging when compared with National Venous Registry data indicating catheters without ultrasound cleared a smaller percentage of the clot (31 percent) in a longer time period (53.4 hours) with double the bleeding complication rate (11.4 percent).
The IMS II ischemic stroke trial, which included the EKOS Micro-Infusion Catheter in as many cases as possible (as determined by the physician), demonstrated a higher rate of reopening of the blocked brain arteries than Phase I of the IMS study, which did not use ultrasound catheters for patients treated with the IV/IA approach (69 percent in IMS II vs. 55.6 percent in IMS I). In addition, IMS II showed that the likelihood of patients to be independent at three months -- a key measure of stroke recovery -- was 1.65-fold higher than that of patients of similar age and stroke severity who were treated with IV alone in the benchmark NIH/NINDS t-PA Stroke Trial. Mortality rates were identical in both studies (16 percent) despite a difference in symptomatic intracranial hemorrhage rate (11 percent in IMS II vs. 6.3 percent in IMS I).
As a result of the positive findings of IMS II, NIH will commence a 40-center Phase III trial later this year to further study the efficacy of combined IA and IV treatment for ischemic stroke using the EKOS Micro-Infusion Catheter.
About EKOS Corporation
EKOS Corporation, a privately held company based in Bothell, Washington, is the world leader in providing ultrasound-assisted, fluid infusion catheters for diagnosis and therapy. Founded in 1995, the company’s products restore blood flow more quickly than traditional catheters in patients with peripheral vascular disease, including peripheral arterial occlusions (PAO) and deep vein thrombosis (DVT). Its technology also has shown promising results in a National Institutes of Health-sponsored study investigating treatments for ischemic stroke. For more information about EKOS, visit: http://www.EKOScorp.com
Media Contact: Jeff Speer FischerHealth 310-577-7870, ext. 156 jspeer@fischerhealth.com
EKOS Corporation
CONTACT: Jeff Speer of FischerHealth, +1-310-577-7870, ext. 156,jspeer@fischerhealth.com, for EKOS Corporation
Web site: http://www.EKOScorp.com/