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 […]
Peripheral/Endo
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 […]
PQ Bypass Receives FDA “Breakthrough Device Designation” for the World’s First Fully Percutaneous Femoral-Popliteal Bypass Device
Designation Expedites Physician Access to Device for Patients with Extremely Long and Complex SFA Lesions MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug […]
InspireMD Announces the European Society of Cardiology 2020 “Best Poster Award” for Updated Data from the PARADIGM-EXTEND Study
TEL AVIV, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) — InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announces the award for Best ESC Congress Poster for the presentation of updated data from […]
JanOne confirms stability data of JAN101 development batch and prepares for commercial GMP production to support the upcoming PAD and potential Covid-19 clinical trials
Bottling and labeling partner Eurofins CDMO (Alphora Research, Inc.) to ensure JanOne clinical research maintains compliance with GMP and FDA regulations LAS VEGAS, Sept. 3, 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, has confirmed stability […]
CMS Grants Additional Reimbursement For The Eluvia™ Drug-Eluting Vascular Stent System
MARLBOROUGH, Mass., Sept. 3, 2020 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced that the U.S. Centers for Medicare and Medicaid Services (CMS) granted a New Technology Add-on Payment (NTAP) for the Eluvia™ Drug-Eluting Vascular Stent System as part of the 2021 Inpatient Prospective Payment System (IPPS). The NTAP designation, awarded to new medical […]
Abbott Announces Start of Trial to Evaluate the New Esprit™ BTK Drug-Eluting Resorbable Scaffold
– The LIFE-BTK trial will evaluate the company’s new drug-eluting resorbable scaffold (DRS), known as the Esprit BTK System, for the treatment of blocked arteries below-the-knee (BTK) – Esprit BTK was granted breakthrough device designation by the U.S. FDA – There are no stents or drug-coated balloons currently approved for […]
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