WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, the exclusive developer of Serration Angioplasty (Serranator®), announced the results of a comparative sub-analysis of the PRELUDE-Below-the-Knee (BTK) study versus Plain Old Balloon Angioplasty (POBA). The study was led by Dr. Marianne Brodmann (Radcliffe Cardiology, Graz, Austria). This sub-analysis compared their PRELUDE-BTK subset to a consecutive […]
Peripheral/Endo
Humacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease
– HAVs observed to provide long-term perfusion to patients with critical limb ischemia – 3D Angiograms show mechanical durability of engineered human blood vessels DURHAM, N.C., Jan. 24, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue […]
Surmodics Provides Regulatory Update Related to its FDA Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received a letter from the U.S. Food and Drug Administration (FDA; the Agency) related to its premarket approval (PMA) application for the SurVeil™ drug-coated […]
Differentiated Capabilities of Surmodics’ Crystalline Drug Release Platform for Sirolimus-Coated Balloons Presented at ISET Conference
Surmodics’ proprietary Crystalline Drug Release (CDR) platform enhances sirolimus stability, transfer, and retention in tissue CDR discussed in connection with 12-month data from Surmodics’ SWING trial of the Sundance™ Sirolimus-Coated Balloon January 19, 2023 08:30 AM Eastern Standard Time EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX) (the “Company”), a leading provider of […]
Inari Medical Announces First Patient Enrolled in the DEFIANCE Trial, Randomized Controlled Trial Evaluating Clinical Outcomes of the ClotTriever® System in Deep Vein Thrombosis
IRVINE, Calif., Jan. 12, 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, today announced that the first patient has been enrolled in DEFIANCE, a prospective randomized controlled […]
Avinger Announces 510(k) Filing of Pantheris LV
Pantheris LV Represents the Next-Generation of Onboard Image-Guided Technology for the Treatment of Peripheral Artery Disease REDWOOD CITY, CA / ACCESSWIRE / January 11, 2023 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease […]
PENUMBRA LAUNCHES LATEST INNOVATION IN MECHANICAL THROMBECTOMY: LIGHTNING FLASH™
Lightning Flash™ is the most advanced mechanical thrombectomy system on the market to address venous and pulmonary thrombus Next generation technology combines superior catheter design with the latest dual clot detection innovation ALAMEDA, Calif., Jan. 10, 2023 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced the U.S. Food […]
Instylla Announces Enrollment of Initial Patient in the Prospective Multicenter “HALT” Study
Pivotal study to evaluate Embrace™ Hydrogel Embolic System for the embolization of arterial bleeds in the peripheral vasculature BEDFORD, Mass., Jan. 10, 2023 /PRNewswire/ — Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the enrollment of the first patient in the HALT Study1 for the treatment of peripheral […]
Cardiovascular Systems, Inc. Announces FDA 510(k) Submission of Innova Vascular, Inc.’s Thrombectomy System
System includes mechanical and aspiration thrombectomy devices to treat peripheral vascular disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that Innova Vascular, Inc. (Innova) has submitted a […]
Major Clinical Study Using Semler’s QuantaFlo® for Medicare Advantage Beneficiaries, Demonstrates that National, In-Home Screening for Peripheral Artery Disease (PAD) is Feasible
SANTA CLARA, Calif., Dec. 14, 2022 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides technology solutions to improve the clinical effectiveness and efficiency of healthcare providers, today announced that a study was published in the peer-reviewed AJPM Focus with data collected using the company’s QuantaFlo® PAD test under real-world conditions, illustrating the benefits […]
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