CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and […]
Tag: atherectomy
Ra Medical Systems Announces Enrollment of First Patient in Pivotal Atherectomy Clinical Study
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces enrollment of the first patient in its pivotal study to evaluate the safety and effectiveness […]
Rex Medical Receives 510k Clearance for Revolution™ Peripheral Atherectomy System
CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Rex Medical, L.P., a medical device design and development company, today announced that it has received 510k Clearance from the U.S. Food and Drug Administration (FDA) for the Revolution™ Peripheral Atherectomy System. Regulatory clearance was based on data […]
DABRA Excimer Laser Atherectomy to be Presented in Key Events at Charing Cross International Symposium
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED) today announced the schedule of key DABRA Excimer Laser Atherectomy events at the upcoming Charing Cross International Symposium in London April 16–18. These events include case and podium presentations and hands-on workshops with […]
Cardiovascular Systems, Inc. Announces First Commercial Launch of Peripheral Orbital Atherectomy System Outside the United States
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in Hong Kong has been treated […]
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. […]
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 […]
Ra Medical Systems Launches Cardiovascular and Dermatology Catheters and Lasers in Northern Europe
Carlsbad, CA—April 6, 2017 (BUSINESS WIRE) Ra Medical Systems, makers of excimer lasers and catheters for cardiovascular and dermatological diseases, and bo medical technologies, a multinational medical device sales and service distributor, announce the launch of the DABRA Atherectomy System […]
Cardiovascular Systems Snags FDA Nod for Its Diamondback 360 Coronary Orbital Atherectomy System (OAS)
Cardiovascular Systems, Inc. Receives Approval for the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Micro Crown in the United States OAS Micro Crown Approved to Treat Severely Calcified Coronary Lesions Only Atherectomy Device Designed to Both Pilot Tight Lesions and […]