Ekos (Bothell, Washington) launched the EkoSonic Mach4e with Rapid Pulse Modulation (RPM) for the dissolution of vascular blood clots today at the 36th annual VEITHsymposium in New York.
Last year Ekos introduced its second-generation EkoSonic endovascular system with RPM and this year the company introduced the Mach4 upgrade.
"We continue to listen to our customers in assessing how we can further improve the performance and simplicity of operation," said Robert Hubert, president/CEO of Ekos. "The Mach4e upgrade addresses both categories."
For performance, Hubert said Ekos has achieved even faster removal of arterial and venous clots (accelerating thrombolysis speed by up to 40%) making it even faster than the previous version of the device, the Mach4.
"We're always striving to improve the speed," Hubert told Medical Device Daily.
For simplicity, the company has eliminated user inputs, which can be safely automated without requiring operator attention, Hubert said.
"The system is much smarter. A world-class vascular innovation forum like the VEITHsymposium is the ideal event at which to launch the Mach4e."
Hubert told MDD that when Ekos launched the second-generation device last year the company was already thinking ahead to the next upgrade. Ekos built into the hardware the ability to upgrade, he said. So all Ekos' customers have to do, if they already have the Mach4, is upgrade to the new generation via an easy software download, he said.
"In fact, their entire inventory of devices ... it will recognize the new upgrade so all of their inventory automatically performs to the new level," Hubert said.
The EkoSonic is FDA-cleared for controlled and selective infusion of physician-specified fluids, including thrombolytic, into the peripheral vasculature. Ekos said the device is currently used to treat patients with peripheral arterial occlusions and deep vein thrombosis and additional applications are being investigated.
So far, customer feedback has been positive, Hubert said.
"We actually had a pre-launch where we had some of our systems go out into the market to get a feel for the products actual ability and, true to form, what we saw in the lab has been what we're getting," Hubert said.
According to the company, providers can "Ekos it anywhere" in the periphery – veins, arteries, IVC filters and difficult-to-reach places such as behind valves – and the device exposes clot to a greater drug uptake.
Ekos touts several other benefits of the Mach4e, including: thrombus of any size, shape, volume and age can be treated with less lab time; uses 50% to 70% less lytic drug, no thrombus fracture or breakage reducing the risk of distal embolism; no hemolysis, no damage to valves or vascular wall; a higher level of vessel patency, removes the thrombus more completely, possibly reducing the risk of post-thrombotic syndrome.
"If you look at where thrombus occurs, it occurs on the venous side, it occurs on the arterial side, it is small, it is large ... you can Ekos any size, any length on the venous side, on the arterial side ... fundamentally anywhere," Hubert said. "We have no limits."
Ekos said it is currently participating in the ATTRACT trial which will evaluate the long-term benefits of using ultrasound catheter-directed thrombolysis for removal of clot.
The VEITHsymposium, now in its fourth decade, provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a format to learn about what is new and important in the treatment of vascular disease. The five-day event, which kicked off yesterday in New York, features presentations from vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. n
Amanda Pedersen, 229-471-4212;