Peripheral/Endo

Avinger Announces Treatment of First Patients Globally With Next Generation Pantheris

REDWOOD CITY, Calif., Jan. 03, 2018 (GLOBE NEWSWIRE) — Avinger(NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced that Arne Schwindt, M.D., a vascular surgeon at St. Franziskus Hospital in Münster, Germany, has successfully treated the first seven patients with the next generation Pantheris Lumivascular atherectomy system. […]

Avinger Announces 510(k) Filing of Next Generation Pantheris Device

REDWOOD CITY, Calif., Dec. 21, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced the Company submitted a new 510(k) application to the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided […]

Mentice Acquires Endovascular Business from Medical Simulation Corporation

GOTHENBURG, Sweden–(BUSINESS WIRE)–Mentice boosts its US development presence and adds a clinical training service line with the acquisition of Medical Simulation Corporation’s (MSC) Medical Products division. Mentice is the global leader of simulation-based performance solutions for endovascular therapies. Under the agreement, Mentice will acquire the assets of the MSC’s Medical […]

Avinger Receives CE Marking Approval for Next Generation Pantheris Image-Guided Atherectomy Device

REDWOOD CITY, Calif., Dec. 20, 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 its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD. The novel […]

XableCath Scores FDA Clearance for Broadly Effective Catheter

SALT LAKE CITY–(BUSINESS WIRE)– XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can […]

Centers Commence Enrollment in KNOCOUT PE Study to Measure the Impact of Shorter, Even Safer EKOS® Therapy Protocols for Pulmonary Embolism

BOTHELL, Wash.–(BUSINESS WIRE)–BTG plc (LSE: BTG), the global specialist healthcare company, today highlights the commencement of the KNOCOUT PE study. The KNOCOUT PE study will measure how hospitals and patients are benefitting from a new standard of care in the treatment of Pulmonary Embolism utilizing EKOS® therapy with faster, and even […]

Saranas Named Finalist for Prestigious International Cardiovascular Innovation Award

HOUSTON–(BUSINESS WIRE)–Saranas, a medical device company with a new technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced the company was named as one of the Top 4 Innovators at the International Conference for Innovations in Cardiovascular Systems (ICI) in Tel Aviv, Israel. The ICI […]

Velano Vascular Named to 2017 FierceMedTech’s “Fierce 15”

SAN FRANCISCO, Dec. 12, 2017 (GLOBE NEWSWIRE) — Velano Vasculartoday announced that it was named by FierceMedTech as one of 2017’s Fierce 15 med tech companies, acknowledging the company as one of the most promising private companies in the industry for its breakthrough work addressing the world’s growing vascular access challenges. More than one […]

PQ Bypass Receives IDE Approval to Initiate Study of First-of-its-Kind Procedure for Patients Suffering From Peripheral Artery Disease

SUNNYVALE, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., today announced it has received conditional approval of its investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial. As the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II will evaluate the safety and […]

Janssen Submits Supplemental NDA to FDA Seeking New Indications for XARELTO (rivaroxaban) for Patients With Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD)

RARITAN, N.J., Dec. 11, 2017 /PRNewswire/ — Janssen Research & Development today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for two new XARELTO® (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke […]