Ekos (Bothell, Washington) has launched a device that it says provides a safer, faster and more complete way to remove dangerous blood clots.
According to the company, the recently FDA-cleared EkoSonic endovascular system (ES) with Rapid Pulse Modulation (RPM) is the only endovascular system that can deliver microsonic energy and thrombolytic drugs simultaneously, with no evidence of thrombus breakage or hemolysis.
Robert Hubert, president/CEO of Ekos, told Medical Device Daily the EkoSonic stands out from other endovascular systems on the market because most of these other devices are mechanical and therefore not as safe as the EkoSonic ES.
He said that Ekos' technology avoids hemolysis, a complication often associated with lengthy mechanical procedures and associated with kidney failure complications.
"Unlike mechanical devices, Ekos technology does not fracture the thrombus or damage red blood cells," Hubert said. "Faster clot dissolution means a lower lytic drug dosage, resulting in fewer complications. Physicians can treat patients in less time, with even greater clinical confidence."
The technology uses ultrasound to temporarily loosen and separate the fiber of the blood clot the fibrin for more blood clot permeability, according to Ekos. The ultrasound also helps push the drug deep into a blood clot to accelerate thrombolysis and dissolve the clot, the company said.
Using ultrasound to open up and dissolve blood clots is a technique that has been studied for four decades, Hubert said. Ekos has developed a way to miniaturize the ultrasound devices that are embedded inside the catheter, he said.
Also, the catheter itself is an "intelligent drug-delivery catheter," which he described as designed to automatically sense what is happening during its use in real time.
The company's Mach 4 device an earlier generation of the technology — has been on the market for two years, Hubert noted. The difference between it and the EkoSonic is that the new device offers the RPM strategy, a new method of attacking the clot by disrupting it two times faster than the Mach 4 and four times faster than conventional catheter-directed thrombolysis.
In addition to its RPM technology, the EkoSonic ES design features an advanced control unit with an easier, more intuitive user interface, making set-up and operation simple, EKOS said. EkoSonic ES is also compatible with the EkoSonic Mach 4.
The Mach 4 was specifically created to be compatible with the RPM technology, the company noted. The Mach 4 offers a variety of treatment zone options. Each Mach 4 consists of a MicroSonic Core within an intelligent drug-delivery catheter. This combination device enables the system to deliver microsonic energy and drugs simultaneously to accelerate clot dissolution, Ekos said.
The EkoSonic system is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytic, into the peripheral vasculature. It is used to treat patients with peripheral arterial occlusions and deep vain thrombosis.
The company says the technology also may some day change the way ischemic stroke patients are treated. In 2006 Ekos received a grant from the National Institute for Neurological Disorder and Stroke, a division of the National Institutes of Health, to develop an ischemic stroke therapy that provides faster restoration of blood flow to the brain tissue.
Ekos said preclinical studies demonstrated that the addition of ultrasound contrast agents to ultrasound accelerated enzymatic thrombolysis and so could significantly augment the rate of clot lysis.
According to EKOS, physicians have responded favorably over the past three years after performing nearly 6,000 cases using the EKOS technology.
"We predict that the EkoSonic will become the new gold standard to treat patients with vascular thrombosis," Hubert said.
Major U.S. medical centers using the EkoSonic ES, according to Ekos, include Baptist Cardiac & Vascular Institute (Miami, Florida), Cleveland Clinic Foundation, Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire), Emory University Hospital (Atlanta), Massachusetts General Hospital (Boston), The Methodist Hospital (Houston), University of Illinois Medical Center at Chicago, and the Swedish Medical Center (Seattle).