Inari Medical’s Artix arterial thrombectomy system includes the Artix MT mechanical thrombectomy catheter and Artix Thin-Walled Thrombectomy Sheath, both pictured here. [Image courtesy of Inari Medical]
Working with physicians to refine Artix since then, Inari has won FDA 510(k) clearances in 2023 and, most recently, in October 2024 to set up the system’s full market release by the end of 2024.
“With Artix we aim to raise the bar and set a new standard for arterial thrombectomy,” the company said in a brief social media announcement about that latest FDA clearance. “Artix is a dual aspiration [and] mechanical arterial thrombectomy solution that delivers control, versatility, and unmatched performance, allowing physicians to capture all clots in one system.”
Inari Medical employees in sales and marketing said in their own social media posts that the first commercial case took place on Oct. 19 at Norwalk Hospital in Connecticut.
To learn more about the Artix system, we reviewed financial disclosures, FDA filings and investor presentations. Here’s what we know so far:
Inari Medical’s Artix thrombectomy system
Inari Medical’s Artix arterial thrombectomy system includes the FlowSaver Blood Return System (center), the Artix AX aspiration catheter (green), the Artix Thin-Walled Thrombectomy Sheath (Blue) and the Artix MT mechanical thrombectomy device (at the distal end of the blue catheter). [Image courtesy of Inari Medical]
The Artix MT and Artix AX are both intended for use in the peripheral vasculature and indicated for “the non-surgical removal of emboli and thrombi from peripheral blood vessels; and injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.”
The Artix AX is a single-use, over-the-wire aspiration catheter that comes in lengths of 85 cm and 115 cm, while the Artix MT is designed to grab and remove acute or chronic blood clots.
Both of the catheters are introduced with the Artix thin-walled sheath, which has an expanding nitinol funnel catheter at the end for “optimal clot capture,” Inari said in an October 2024 presentation to investors.
Inari Medical’s Artix MT mechanical thrombectomy catheter features an expandable nitinol basket for capturing and removing blood clots. [Image courtesy of Inari Medical]
Because aspiration catheters remove blood along with clots, the FlowSaver Blood Return System is designed to minimize intraprocedural blood loss. The system removes clot from aspirated blood for reinfusion into the patient using 40-micron filtration.
Treating ALI with Inari Medical’s Artix system
This image shows the distal ends of the catheters in Inari Medical’s Artix thrombectomy system [Image courtesy of Inari Medical]
The device developer says there’s a “lack of purpose-built tools” for ALI patients, which more than half undergoing open embolectomy. The device developer estimates the total addressable market (TAM) for ALI is around $600 million in the U.S.
ALI is just one of the Emerging Therapies segments for Inari Medical, which estimates U.S. TAMs for the rest as approximately $1.5 billion for chronic limb-threatening ischemia (CLTI, treated with Inari’s LimFlow system), about $1 billion for dialysis access management (DAM), and another $1 billion for chronic venous disease (CVD).
The company estimates 80,000 U.S. patients each year present with ALI or other arterial thromboembolism in the peripheral vasculature, such as acute visceral ischemia and certain cases of chronic limb ischemia.
Inari Medical’s FlowSaver Blood Return System [Image courtesy of Inari Medical]
“We believe the best way to treat ALI and related diseases is to quickly, safely and effectively remove the clot,” the company continued. “We are purposefully designing our Artix system to effectively remove thrombosis to alleviate the symptoms of these underlying and emergent diseases, and we plan to continue developing solutions for these disease states.”
