OSAKA, Japan–(BUSINESS WIRE)–Gunze Limited (Headquarters: Osaka, Japan, President: Atsushi Hirochi) [TOKYO:3002] is pleased to announce that Gunze’s biodegradable scaffolds are being provided to the Abigail Wexner Research Institute at Nationwide Children’s Hospital (Location: Columbus, OH, USA) to conduct its first human tissue engineered vascular grafts (hereinafter TEVG), clinical trial. 1. […]
Peripheral/Endo
Surmodics Receives FDA 510(k) Clearance for Pounce™ Thrombus Retrieval System
Next-generation technology provides easy, effective clot removal from peripheral arterial vasculature 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, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ Thrombus Retrieval System. […]
W. L. Gore & Associates Enhances GORE® VIABAHN® Endoprosthesis Portfolio With Lower Profile Delivery
Improvements to large diameter devices include accessibility through smaller sheaths while providing enhanced visualization under fluoroscopy FLAGSTAFF, Ariz., Sept. 22, 2020 /PRNewswire/ — As part of efforts to continuously improve medical solutions for patients with complex vascular disease, W. L. Gore & Associates, Inc. (Gore) announced the U.S. launch of the lower profile, large […]
AngioDynamics Announces Commercial Launch of Auryon Atherectomy System in United States
ADVANCED MEDICAL TECHNOLOGY SAFELY1 & EFFECTIVELY TREATS PAD, CLI, ISR LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced the launch of the Auryon Atherectomy System, a newly-developed innovative technology for the treatment of Peripheral […]
Prytime Medical™ Launches New ER-REBOA™ PLUS Catheter
REBOA refined. REBOA made easier. SAN ANTONIO–(BUSINESS WIRE)–Prytime Medical Devices, Inc. introduced its latest aortic occlusion catheter, the ER-REBOA™ PLUS this week at the American Association for the Surgery of Trauma (AAST) Annual Meeting. Designed for improved ease of use, it is REBOA refined for controlling massive non-compressible hemorrhage. “The […]
Shape Memory Medical Announces First Patient Enrollment in AAA-SHAPE Study
SANTA CLARA, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of innovative therapies for cardiovascular and neurovascular markets, announced the initiation of AAA-SHAPE, the Company’s prospective safety study of the IMPEDE-FX Embolization Plug devices when used for abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). The study’s first […]
JanOne Announces Strategic Plan to Divest its Legacy Businesses
Update on plans for sale of recycling business. Divesting will allow for focus on core life science assets LAS VEGAS, Sept. 16, 2020 /PRNewswire/ — JanOne Inc. (Nasdaq: JAN), a company focused on developing treatments for conditions that cause severe pain and drugs with non-addictive, pain-relieving properties, provided an update today regarding its initiatives […]
Concept Medical announces index patient enrolment in world’s first Randomized Controlled Trial…
Concept Medical announces index patient enrolment in world’s first Randomized Controlled Trial with Sirolimus Coated Balloon for the treatment of Superficial Femoral Artery (SFA) in Peripheral Artery Disease SINGAPORE, Sept. 14, 2020 /PRNewswire/ — Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the FUTURE […]
InspireMD Announces Approval of Investigational Device Exemption (IDE) for Pivotal Study of CGuard Carotid Stent System
IDE Approval to Pave the Way for Pivotal Study of CGuard System for Carotid Artery Disease and Stroke Prevention in the United States TEL AVIV, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke […]
Bayer Phase IV Study Met its Primary Endpoint in PAH Patients Who Had Transitioned to Adempas® (riociguat) After Insufficient Response to PDE5 Inhibitors
Data presented as a late-breaker during a virtual ALERT session at the annual meeting of the European Respiratory Society Outcomes from the randomized, controlled, open-label REPLACE study included results from 226 patients with pulmonary arterial hypertension (PAH) WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced results from the Phase IV REPLACE (Riociguat rEplacing PDE-5i […]



