Euphrates Vascular's Ichor Reperfusion System Cleared by FDA
January 30, 2019—Euphrates Vascular announced that it has received FDA 510(k) clearance for the sale of its Ichor percutaneous reperfusion system, which is designed to treat organized thrombus and embolic events in the peripheral vasculature.
According to the company, Ichor is a one-size-fits-all system that replicates the standard of care of surgical embolectomy/thrombectomy but in a minimally invasive manner. Features of the device include:
- A percutaneous approach that reduces surgical complications
- A mechanism of action that minimizes blood loss associated with aspiration
- A mechanism of action that does not require drug therapy, which potentiates a reduction of common bleeding complications associated with lytics
- No requirement for general anesthesia
- No need for capital equipment (disposable only)
- Ability to be easily adopted by interventionalists
- Incorporation of a health economic element intended to make Ichor a first-line therapy for physicians, hospitals, and office-based labs
Euphrates Vascular stated that Ichor will be the company's first marketable product, with the Pulse NanoMed technology in the pipeline. The Ichor and Pulse NanoMed systems were designed to target vascular occlusions by eliminating the need for surgery or drug therapies, and they attempt to treat further and deeper by overcoming today’s size limitations in material science.
Troy Long, MD, commented in the company's press release, “Ichor will be an extraordinary tool in the clot management toolbox due to its ability to handle the organized clot many physicians struggle to treat. The Pulse NanoMed system may allow for us to change our approach in treating occlusions in areas such as the lower limb, the diabetic foot, and perhaps in the neurovasculature by simply being able to access the most tortuous anatomy and the smallest vasculature. The Pulse NanoMed system can enable us to go where no other devices have gone before.”