The U.K. National Institute for Health and Care Excellence is not utterly opposed to the use of mechanical thrombectomy as a treatment for pulmonary embolism, but the agency believes that the outcomes data for high-risk patients are lacking.
Just weeks after securing U.S. FDA approval for its flagship system to treat chronic limb-threatening ischemia (CLTI), Limflow SA kept the good news flowing to investors with the announcement of an agreement to be acquired by Inari Medical Inc. in a deal valued at up to $415 million. Inari will pay $250 million in cash at closing with up to $165 million in additional payments going to Limflow based on achievement of specified commercial and reimbursement milestones starting in 2025. The companies expect the deal to close by the end of the year.
An analysis of real-world data pulled from Truveta’s electronic health records of 30 U.S. health care systems found that patients treated for pulmonary embolism (PE) using Boston Scientific Corp.’s Ekos endovascular system had lower rates of adverse events, particularly intracerebral hemorrhage, than those treated with Inari Medical Inc.’s Flowtriever system.
Gilde Healthcare Partners BV raised €600 million (US$658 million) in capital commitments for a new investment fund which will be deployed into companies across Europe and the U.S active in digital healthcare, medical technology and therapeutics. The fund, ‘Venture&Growth VI’, will focus on investing in fast growing companies developing solutions for better care at lower cost.
Irvine Calif.-based Inari Medical Inc. reported results from what it described as the largest prospective study of interventional treatment in high-risk pulmonary embolism (PE), which found a 90% survival improvement in high-risk pulmonary embolism using the company’s Flowtriever System. Data from the FLAME (Flowtriever for Acute Massive Pulmonary Embolism) study in high-risk PE was presented at the 2023 American College of Cardiology (ACC) conference on March 5.
Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
Inari Medical Inc. released results from its 800-person Flowtriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) registry in pulmonary embolism (PE) at the 2022 Transcatheter Cardiovascular Therapeutics conference in Boston on Sept. 18 showing that treatment of PE with its Flowtriever device provided immediate hemodynamic and symptom improvement with all-cause mortality rates under 1.0% at 30 days.
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS may reverse non-coverage for catheter pulmonary embolectomy.