Peripheral/Endo

NIH Approves Second Phase of Funding to Support IND-enabling Work for Ambulero Gene Therapy to Treat Vascular Disease

MIAMI–(BUSINESS WIRE)–Ambulero, Inc. is developing a first-in-class gene and cell therapy platform for treating serious vascular diseases and non-healing wounds where amputation is a care option. In support of this effort, the NHLBI CATALYZE program of the National Institutes of Health approved a second phase of funding for IND-enabling work […]

Endologix Receives FDA Approval of the DETOUR™ System to Treat Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Over […]

Inari Medical Announces Commercial Launch of RevCore™ and Triever16 Curve™, Two New Purpose-Built Products for Addressing Venous Stent Thrombosis and Venous Thromboembolism

IRVINE, Calif., June 07, 2023 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced the launch of two new purpose-built products, the RevCore thrombectomy catheter, and the Triever16 […]

Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System

IRVINE, Calif, June 7, 2023 /PRNewswire/ — Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever™ System and its Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two new devices are collectively known as the Laguna Thrombectomy System. […]

Gore announces first U.S. enrollment for the GORE® VIAFORT Vascular Stent iliofemoral Study

CAUTION: Investigational device. Limited by United States law to investigational use. FIRST U.S. PATIENT ENROLLED IN GORE® VIAFORT Vascular Stent ILIOFEMORAL pivotal study FLAGSTAFF, Ariz., June 6, 2023 /PRNewswire/ — W. L. Gore & Associates (Gore) has announced that the first U.S. patient has been enrolled in a prospective, non-randomized, multicenter, single-arm study with five-year follow-up […]

Teleflex Announces the Arrow® EZ-IO® Needle Is Now FDA Cleared For Use in an MRI Environment

First and Only IO Needle with MR Conditional Safety Status Labeling WAYNE, Pa., June 06, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, today announced that the Arrow® EZ-IO® Needle is the first and only Intraosseous (IO) Needle to receive […]

Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration

Lightning Bolt™ 7 is the most advanced arterial thrombectomy system on the market Latest technology combines modulated aspiration with superior catheter design to maximize blood clot removal in a single session ALAMEDA, Calif., June 1, 2023 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced the U.S. Food […]

LIBERTY Robotic Surgical System Achieved Additional Milestone in its Path to First in Human and Regulatory Process

The data collected from the usage and experience of the medical professionals in the formative study will be used to support the Company’s anticipated milestones HINGHAM, Mass., May 31, 2023 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic Surgical System, the first single-use endovascular surgical […]

Concept Medical’s fourth IDE approval for the MagicTouch Sirolimus Coated Balloon is granted for the treatment of Superficial Femoral Artery Disease (SFA)

TAMPA, Fla., May 29, 2023 /PRNewswire/ — The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc’s Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA). This marks the fourth IDE approval for the Company’s Sirolimus coated balloon. The Company has already received three […]

Excellent 12-Month Results from SELUTION SFA Trial Presented at JET

GENEVA, May 30, 2023 /PRNewswire/ — 12-month results from the SELUTION SFA trial have been presented at the Japan Endovascular Treatment (JET) Conference in Tokyo. The objective of this study was to assess the safety and efficacy of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the […]