Vascular medical device corporations Enventric said on the 4th that it obtained product approval for "ULTRIVA," a thrombectomy device for treating acute cerebral infarction, from the Ministery of Food and Drug Safety.
ULTRIVA is a "stent retriever" that directly grips and removes a thrombus blocking a cerebral blood vessel. It is regarded as a key medical device used to quickly reopen blocked vessels in patients with acute cerebral infarction. High technical prowess is required because performance is critical to firmly pull the clot while minimizing vascular damage during removal.
This market has long been dominated by U.S. corporations such as J&J MedTech, Medtronic, and Abbott.
ULTRIVA incorporates Enventric's proprietary fundamental technology "Arch-1." Built by precision-processing an ultra-thin metal tube, it is designed to move smoothly even in highly tortuous cerebral vessels and retrieve clots stably.
In addition, by applying a radiopaque marker directly to the stent structure to check the device's position, clinicians can see the device's location and deployed state more clearly on X-ray images during procedures. The company said this can improve procedural convenience and accuracy for medical staff in emergencies.
The approval is also meaningful from a business perspective. Enventric obtained product approval for the cerebrovascular interventional catheter "EVOGLIDE" in January and, with ULTRIVA now approved as well, has secured a foundation to supply the major equipment needed for thrombectomy in cerebral infarction with its own technology.
EVOGLIDE is a catheter that helps treatment devices inserted through the femoral vessel reach cerebrovascular lesions stably. It is designed for use with ULTRIVA, which the company said can improve procedural efficiency.
Enventric co-CEOs Min Ji-young and Min Sung-woo said, "We plan to complete our device portfolio for cerebral infarction treatment within this year and expand our business into the cardiovascular and cardiac electrophysiology (EP) fields," adding, "We will enhance the competitiveness of domestically made medical devices and grow into a global vascular solutions corporations."