Tag: PAD

Avinger Receives CE Marking Approval for In-Stent Restenosis Treatment Indication With Pantheris Image-Guided Atherectomy

REDWOOD CITY, Calif., Sept. 26, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced Conformité Européenne (CE) Marking approval for treating in-stent restenosis with the Pantheris® Lumivascular atherectomy system. In-stent restenosis occurs when a previously blocked artery treated with […]

Shockwave Medical Shows Off Disrupt BTK Lithoplasty System Study Results

FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark. DISRUPT BTK, a prospective single arm study, evaluated the use […]

iVascular EffPAC 6 Months Outstanding Data Presented at CIRSE 2017 DCB Session

By Anastasia Perebeynos Copenhagen – September 18, 2017 – iVascular SLU data announced today, demonstrate the efficacy of the Luminor drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The 6 months results from the full clinical cohort of the EffPAC randomized study were presented in the DCB session at the […]

SurModics (SRDX) Nabs Global Approvals of .014″ Low-Profile PTA Balloon Dilation Catheter

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearance for its .014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for […]

Six-Month Data From The SurModics (SRDX) Surveil Drug-Coated Balloon Early Feasibility Study Presented At VIVA 2017

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced that data from the PREVEIL early feasibility study (EFS) of the company’s SurVeil®drug-coated balloon (DCB) was shared in a late-breaking clinical trial presentation at the Vascular Interventional Advances (VIVA) 2017 […]

Medtronic (MDT) Announces Japanese Regulatory Approval For The IN.PACT Admiral Drug-Coated Balloon

DUBLIN – September 8, 2017 – Medtronic plc (NYSE: MDT) today announced that the IN.PACT(TM)Admiral(TM) Drug-Coated Balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg – specifically, in the thigh (superficial femoral arteries (SFA)) and […]

Gardia Medical Demonstrates Enhanced Safety in Lower Extremity Interventions

CAESAREA, Israel, Sept. 6, 2017 /PRNewswire/ — Gardia Medical, an Israeli Medical Device Company focused on embolic protection solutions, announced that according to the independent Clinical Events Committee (CEC), Gardia successfully met the primary end-point in its WISE-LE study. The WISE-LE study’s objective is to demonstrate the safety and performance of the […]