Irvine, California–based Inari Medical filed the lawsuit in the U.S. District Court for the Northern District of California. The company, which develops treatments for venous and other diseases, seeks injunctive relief and damages for infringement.
Inari believes Truvic is infringing on eight of its patents for the use of aspiration-based thrombectomy devices to treat pulmonary emboli and deep vein thrombosis (DVT). Among the products named in the suit is Truvic’s Symphony thrombectomy system.
Truvic — also called Imperative Care Vascular following an organizational restructuring last year — was acquired by Imperative Care in 2021. It boasts two FDA-cleared products: the Symphony and Prodigy thrombectomy systems. Symphony offers venous applications, and Prodigy offers peripheral arterial applications. The company already made Prodigy available at select U.S. hospitals, while it outlined plans for a targeted launch for Symphony last summer.
Inari Medical, meanwhile, develops the ClotTriever and FlowTriever. It designed ClotTriever to capture and remove large clot burden from big vessels. Treating patients in one single session, it eliminates the need for thrombolytic and a stay in the intensive care unit. The company hopes to make it the standard of care for DVT patients.
FlowTriever non-surgically removes clots from peripheral blood vessels. Its uses include treatment for PE and clots in transit in the right atrium. It received FDA 510(k) clearance in 2018.
“Inari was founded to improve patients’ lives using purpose-built innovation. Our mission depends on these innovations, and we are deeply committed to protecting our intellectual property rights,” Drew Hykes, CEO of Inari Medical, said in a news release.
More details on the Inari Medial lawsuit against Imperative Care and Truvic Medical
Like Inari’s FlowTriever and ClotTriever systems, Truvic designed Symphony for the non-surgical removal of fresh, soft emboli and thrombi from blood vessels. Inari’s complaint against the company says Symphony most directly competes with its own systems. Meanwhile, Prodigy targets clots in smaller arteries, the lawsuit said.
As Truvic expected, the company began marketing and selling its Symphony system by “mid-2023,” the lawsuit states.
Inari alleges that Symphony “significantly overlaps with and mirrors” the FlowTriever design. The company said the products share similar features and mechanisms, including telescoping aspiration catheters, an intervening member used in addition to the catheter, the design of a hemostasis valve between the aspiration catheter and the aspiration source, and the design of the removable clot-filtering canister, according to the lawsuit.
According to the lawsuit, Inari believes Truvic “intentionally copied” its devices and targets the market Inari seeks to treat. The company also alleges that Truvic recruited and (sometimes successfully) attempted to hire away its own personnel. That included sales representatives with knowledge of the market to which they sold. Inari also alleges that Truvic targeted its network of doctors as well.
The lawsuit alleges that Truvic sales representatives persuaded doctors to allow them to observe procedures performed with Inari devices. Sometimes, Inari claims, they convinced doctors to exclude Inari representatives from being present when its devices are being used.
Inari says it contacted Truvic in September 2023, months after the FDA cleared Symphony. The company says Truvic refused to provide it with one of its Symphony systems for analysis, labeling them confidential. It called Truvic’s response “irregular and concerning.”
The lawsuit states: “Based upon the promotional literature that Truvic has distributed and made available online, as well as statements and actions by Truvic’s sales representatives and Inari’s own examination of a Symphony system that Inari very recently obtained, Truvic directly and indirectly infringes the Inari patents described below through manufacture, sale, offer for sale, and/or use of the Symphony products.”
Statement from Imperative Care spokesperson
An Imperative Care spokesperson issued the following statement to MassDevice via email:
“We do not believe we infringe upon any valid patents. Imperative Care, Inc. takes intellectual property rights seriously, and we will vigorously defend against the claims made by Inari Medical, Inc.”
