Peripheral/Endo

FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent (AMDS)

Ascyrus Medical receives Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. BOCA RATON, FLA. (PRWEB) AUGUST 14, 2019 Ascyrus Medical announced today that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) […]

Cardiovascular Systems, Inc. to Feature LIBERTY 360° Three-year Outcomes Data at 2019 Amputation Prevention Symposium

Company introduces Diamondback 360° Exchangeable Series to treat multi-level PAD 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, today announced that the three-year outcomes from its LIBERTY 360° study will […]

Concept Medical Inc. Granted 2nd ‘Breakthrough Device Designation’ From the FDA for Its MagicTouch PTA Sirolimus Coated Balloon, for the Treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK) Indication

Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first ‘Breakthrough Device Designation’ received by Concept Medical […]

Endologix Receives IDE Approval for the Nellix Chimney EndoVascular Aneurysm Sealing Protocol

IRVINE, Calif.–(BUSINESS WIRE)–Endologix, Inc. (Nasdaq:ELGX), a developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption (“IDE”) approval from the United States Food and Drug Administration (“FDA”) to commence a new pivotal study to evaluate the safety and effectiveness of the Nellix […]

Cardiovascular Systems, Inc. Acquires Gardia Medical Ltd.’s WIRION™ Embolic Protection System

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 it has acquired the WIRION Embolic Protection System and related assets from Gardia Medical Ltd., a wholly owned Israeli […]

Vascular Graft Solutions Announces CE Mark Approval for FRAME FR External Support for AV Fistula Repair

TEL AVIV, Israel, Aug. 5, 2019 /PRNewswire/ — VGS – Vascular Graft Solutions Ltd. announced today it has received CE Mark Approval for the FRAME FR, a novel solution for repair and stabilization of high flow and aneurysmal arteriovenous fistulas in hemodialysis patients. Although AV fistula is the preferred access for hemodialysis, up to […]

Teleflex Announces Publication of “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device”

WAYNE, Pa., Aug. 01, 2019 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX) today announced the publication of the “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device.” The SAFE MANTA IDE Clinical Trial, the largest U.S. prospective multi-center study of a purpose-designed large […]

Reflow Medical Enrolls First Patients in DEEPER OUS Spur Stent Trial

San Clemente, Calif., July 30th, 2019–(BUSINESS WIRE) —Reflow Medical, Inc. announces that the first patients have been enrolled in its DEEPER OUS clinical trial using the Temporary Spur Stent System. DEEPER OUS is a 100-patient prospective, non-randomized, multicenter trial designed to assess the safety and efficacy of the Temporary Spur Stent […]

Avinger Announces Pantheris SV Limited Launch and Successful Treatment of First Patients in the United States

REDWOOD CITY, Calif., July 29, 2019 (GLOBE NEWSWIRE) — Avinger, Inc. (Nasdaq: AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in four U.S. sites have successfully treated several patients with […]

Medtronic Launches the VenaSeal Closure System in India to Treat Patients With Chronic Venous Diseases

Newly Approved Minimally Invasive Therapy Treats Diseased Veins Using Proprietary Medical Adhesive Mumbai, Maharashtra, India:  India Medtronic Private Limited, wholly owned subsidiary of Medtronic plc (NYSE: MDT), today announced the launch of the VenaSeal™ Closure System, which is a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased vein […]