The Latest Cardiac and Vascular News
REDWOOD CITY, CA / ACCESSWIRE / April 26, 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 vascular disease, today announced the company has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for […]
HANGZHOU, China, April 23, 2023 /PRNewswire/ — Zylox-Tonbridge Medical Technology Co., Ltd. (2190. HK, the “Company”) announced the signing of a strategic agreement with Guangdong Hicicare Science Co., Ltd. (“Hicicare”). With the collaboration, Zylox-Tonbridge and Hicicare plan to introduce and help accelerate the commercialization of co-branded vascular guidewire products in the neuro- […]
Registry to enroll up to 500 patients at up to 30 sites, collecting real-world outcomes data for the Pounce™ Thrombectomy System EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in PROWL, the Pounce™ […]
The phase II clinical trial to be conducted by the University and BioGenCell will focus on patient responses to novel cell therapy, with the aim of saving limbs and enabling a better quality of life for those suffering [California, USA, April 20, 2023] – BioGenCell, the leading personalized cell therapy […]
Sublime Radial Access Platform to include the industry’s first suite of torqueable peripheral microcatheters, designed for navigating tortuosity and crossing complex lesions and available for both transradial and transfemoral procedures EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health […]
Lava® LES is the first liquid embolic product approved by the FDA for use in the peripheral vasculature HAYWARD, Calif., April 18, 2023 /PRNewswire/ — Bay Area-based BlackSwan Vascular, Inc., a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval […]
PROMISE II Trial Met Primary Endpoint Therapy Demonstrates 76% Limb Salvage in Patients with Chronic Limb-Threatening Ischemia Who Otherwise Faced Amputation PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today […]
Announces Receipt of Positive Formal FDA Feedback via the Q-Submission Program Substantially reduces the anticipated time and cost needed to receive a PMA 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 that it has […]
CAUTION: Investigational device. Limited by United States law to investigational use. FIRST U.S. PATIENT ENROLLED IN GORE® VIAFORT Vascular Stent pivotal study FLAGSTAFF, Ariz., March 28, 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 5-year […]
GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ — Getinge’s iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease. Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), a serious condition that only in the US […]
