Peripheral/Endo

PIVLAZ (clazosentan) – Idorsia’s first commercial product – now available for patients in Japan

In Japan, PIVLAZ™ (clazosentan) 150 mg, is indicated for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing. With the positive listing decision, Japan’s National Health Insurance system has recognized that the clinical efficacy demonstrated with PIVLAZ fulfills an important medical […]

Avinger Announces Full Commercial Launch of Lightbox 3

REDWOOD CITY, CA / ACCESSWIRE / April 19, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company developing and marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of vascular disease, today announced full commercial availability of its new Lightbox 3 imaging console designed to enhance the […]

BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021″ steerable microcatheter

TEL AVIV, Israel, April 18, 2022 /PRNewswire/ — BENDIT Technologies, a company focused on the development of a steerable microcatheter platform, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter for treatment in the neuro, peripheral, and coronary vasculature. The clearance was received several […]

Penumbra Announces the European Launch of the Indigo® System With Lightning™ 7 and Lightning 12 Intelligent Aspiration

Physicians in Europe now have access to Penumbra’s most advanced mechanical thrombectomy technology available, which has had a significant impact on patients in the U.S. Designed for single session blood clot removal in peripheral arterial and venous systems, including the treatment of pulmonary embolisms First and only computer-aided mechanical aspiration […]

Koya Medical Launches Dayspring® Lower Extremity Active Compression Treatments for Lymphedema and Venous Disorders

Centers for Medicare & Medicaid Services (CMS) issues new Healthcare Common Procedure Coding System (HCPCS) codes for Dayspring lower extremity active compression OAKLAND, Calif.–(BUSINESS WIRE)–Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced the U.S. […]

FDA Clears Four New Coronary Micro Support Catheters

Non-tapered metal-alloy support catheter platform receives FDA clearance for use in coronary and peripheral vasculature. Transit Scientific now has one of the largest platforms of FDA cleared microcatheters in the industry. PARK CITY, Utah, April 12, 2022 /PRNewswire/ — Transit Scientific announced the FDA clearance of its XO Cross® Support Catheter Platform to […]

Alucent Biomedical Announces First Patient Enrolled in First In Human Natural Vascular Scaffolding Clinical Trial

Multicenter ACTIVATE II Study to Enroll up to 50 Patients in Australia SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. announced that it has enrolled the first patient in ACTIVATE II, an Australia-based First-in-Human clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (AlucentNVS) technology. The therapy is […]

TRUVIC Announces 510(k) Clearance for the Prodigy™ Thrombectomy System

First regulatory milestone as part of a strategy to advance patient care CAMPBELL, Calif.–(BUSINESS WIRE)–Truvic Medical, Inc., a wholly owned subsidiary of Imperative Care, Inc., today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Prodigy™ Thrombectomy System, designed for the treatment of peripheral […]

Sky Medical Technology announces availability of its geko™ device on government of India e-marketplace portal (GeM)

With this move, government hospitals across India can now access the geko™ device to prevent life threatening blood clots, address complications related to swelling following orthopaedic surgery and the healing of chronic wounds (leg ulcers). DARESBURY, England, April 6, 2022 /PRNewswire/ — Sky Medical Technology Ltd (Sky), a UK-based medical device manufacturer and parent company […]

Ra Medical Systems Granted U.S. Patent for Laser Ablation Catheters with Expanded Ablation Area

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces the United States Patent and Trademark Office has granted the company a patent for liquid-filled laser ablation catheters with expanded distal optical windows. U.S. patent […]