Date: Aug 27, 2005 Source: NIH Success Stories (
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Technology Developed:
NIH SBIR/STTR funding enabled EKOS Corporation to develop and commercialize ultrasonic infusion systems intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS MicrolysUS® infusion system is a 510K cleared device to treat peripheral arterial occlusion. In addition, this microcatheter has IND approval to participate in Phase II Interventional Management of Stroke (IMS) clinical study to treat ischemic stroke using a combined IV/IA rtPa infusion approach.
The EKOS LysUS® infusion system is also a 510K cleared device to treat peripheral arterial occlusion. This 5 Fr catheter system is available in treatment zone ranging from 6 to 50 cm to match a variety of clot lengths and ensure uniform drug/ultrasound energy distribution into the large arterial and venous clots found in the peripheral vasculature. Besides the therapeutic application, EKOS devices have a diagnostic feature to monitor blood flow in occluded lesions during the treatment. The flow sensor feature is based on the catheter ultrasonic element's temperature that will be monitored and displayed on the EKOS control unit, which additionally provides power to drive catheter ultrasonic elements. The temperature variations directly correspond to the local flow rate of the blood in the occluded lesion and inform the doctors of the treatment status.
We believe EKOS infusion catheters provide unique benefit to the patient with vascular thrombotic occlusions in the cerebral and peripheral vasculature. In ischemic stroke, accelerated thrombolysis leads to faster restoration of nutrient blood flow to the ischemic tissue and greatly improves the patient's chances of survival with minimum brain damage and reduced burden of neurologic deficits. Potential benefits specific to the infusion of thrombolytics with EKOS LysUS® infusion system to treat peripheral arterial occlusion may include a decreased thrombolysis time (e.g., decreased time from the start of the procedure to recanalization) due to the improved dispersion and availability of the thrombolytic within the clot. This in turn may reduce the amount of thrombolytic agent used.
Uses of Technology/Products/Service:
Peripheral arterial occlusion (PAO) of the lower extremity can cause limb-threatening ischemia and, if left untreated, is associated with a high rate of amputation. The standard of treatment for many years has included open surgical intervention, but this carries a significant risk to life and limb. Attempts to treat PAO by intravenous infusion of thrombolytics have met with low success, and unacceptably high rates of morbidity resulting from serious hemorrhagic events (Kandarpa, 2000; Kessel et al; 2004, Berridge et al, 1991). In 1974 Dotter et al (Dotter et al, 1974) introduced the concept of infusion of thrombolytic agents directly near, or into, the site of occlusion. Efficacy was attained with greatly decreased dosage levels; mortality and morbidity were decreased. The EKOS Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids into the peripheral vasculature. Infusion of thrombolytic agents is included in the intended use of the EKOS infusion system. Potential benefits specific to the infusion of thrombolytics with this system may include a decreased thrombolysis time (e.g., decreased time from the start of the procedure to recanalization) due to the improved dispersion and availability of the thrombolytic within the clot. This in turn may reduce the amount of thrombolytic agent used. This result in reduced patient discomfort, reduced risk of hemorrhage as a potential side effect of thrombolytics and better patient health, and cost savings to health care providers. The diagnostic flow sensor feature of EKOS Infusion systems could provide doctors with real-time insight into the recanalization status of the occluded lesion and could be used as an indicator for the end of treatment.
Benefit to Company:
NIH SBIR/STTR funding provided development of critical testing and contributed to the development and commercialization of devices which we believe will improve the health of 150,000 American patients with Peripheral arterial occlusions and up to 500,000 patients who suffer from ischemic strokes each year.
How Product Was Commercialized:
While currently cleared by the FDA for sale in the US, EKOS is electing to introduce these products in a controlled release while collecting user feedback and experience. Full market release for the peripheral products is expected in Q4-05 and for the microcatheter in Q1-06.
Other Comments Related to Company's Success Story:
At a time when many U.S. manufacturing jobs have been outsourced overseas, worldwide sales of EKOS infusion systems will create manufacturing jobs in Northwest of the USA.
