Peripheral/Endo

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 […]

Endologix Announces First Commercial Implant of ALTO Abdominal Stent Graft System Outside of United States

IRVINE, Calif.–(BUSINESS WIRE)–Furthering its mission to transform the treatment of aortic disorders, Endologix, Inc. (OTC: ELGXQ) (“Endologix” or the “Company”) today announced the first implant of its recently approved ALTO® endograft outside of the United States, completed by Andrew Holden, MD, and Andrew Hill, MD, of Auckland City Hospital, Auckland, New […]

Baylis Medical Announces First Clinical Use of the All-in-One VersaCross® Steerable Solution

TORONTO, Sept. 1, 2020 /PRNewswire/ – Baylis Medical announced today the first clinical use of the VersaCross Steerable Access Solution, performed at the University of California, San Francisco (UCSF). The newest addition to the VersaCross Transseptal Platform combines the VersaCross RF wire with a steerable sheath, making it the ultimate, all-in-one solution to enable […]

Genesis MedTech Acquires World-first Drug-coated Balloon Technology with Next-generation Angioplasty Architecture for the Treatment of Peripheral Vascular Diseases

– Provides patients suffering from peripheral vascular diseases a safer and more effective treatment than traditional balloon angioplasty – DCB to become the future standard of care for superficial femoral artery treatment – Fast growing global market with estimated 13% CAGR, to reach around US$1billion by 2025 SINGAPORE, Aug. 31, 2020 /PRNewswire/ […]

Veryan Launches BioMimics 3D Vascular Stent System in the US

Press release Horsham, UK 01 September 2020 Veryan Medical (Horsham, UK) today announced that it has launched the innovative BioMimics 3D Vascular Stent System in the US. The BioMimics 3D self-expanding, nitinol stent features a highly- differentiated, helical centre-line design that has achieved excellent clinical outcomes in clinical trials, including […]

Philips to expand its image-guided therapy devices portfolio through acquisition of Intact Vascular

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has signed an agreement to acquire Intact Vascular, Inc., a U.S.-based developer of medical devices for minimally-invasive peripheral vascular procedures. Intact Vascular will enhance Philips’ image-guided therapy portfolio, combining Philips’ interventional imaging platform […]

JanOne Advances its Potential Peripheral Artery Disease and Covid-19 Vascular Inflammation Treatment Towards Trial Readiness

Engineering batch for JAN101 complete and expectations are for GMP batch production to begin within 30 days LAS VEGAS, Aug. 26, 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 successfully completed its initial engineering batch […]

ROADSTER 2 Data Publication in Stroke Demonstrates Compelling Patient Outcomes and Strong Safety Profile with TCAR

SUNNYVALE, Calif., Aug. 19, 2020 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that ROADSTER 2 study results have been published in the latest edition of the American Heart Association’s journal, Stroke. The article, “Early Outcomes […]