Peripheral/Endo

MERIT MEDICAL RECEIVES TWO ADDITIONAL FDA BREAKTHROUGH DEVICE DESIGNATIONS

SOUTH JORDAN, Utah, April 06, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has been granted two additional Breakthrough Device designations […]

Landmark Phase 3 VOYAGER PAD Study of XARELTO® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization

XARELTO® has the potential to be the first anticoagulant in 20 years(i) to show a benefit in these high-risk patients Two major Phase 3 trials have evaluated XARELTO® vascular dose plus aspirin in treating patients with atherosclerotic disease RARITAN, N.J., March 28, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & […]

Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session

Highlights include four late-breaking XARELTO® (rivaroxaban) abstracts Four INVOKANA® (canagliflozin) abstracts from the pivotal CREDENCE study will also be presented RARITAN, N.J., March 20, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the […]

Endologix Receives FDA Approval for Alto Abdominal Stent Graft System

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX) (“Endologix” or the “Company”), a developer and marketer of innovative treatments for aortic disorders, today announced that it has received approval from the United States Food and Drug Administration (FDA) for the Alto™ Abdominal Stent Graft System (Alto). The Company received approval based on its […]

CryoLife Receives CE Mark for E-vita Open NEO™ Hybrid Stent Graft

March 4, 2020 at 4:05 PM EST Newest Hybrid Stent Graft Offering Enhances Ease-of-Use ATLANTA, March 4, 2020 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment […]

Okami Medical Announces First Patients Treated With The LOBO Vascular Occluder

Microcatheter-delivered device provides fast and focal occlusion of peripheral arterial targets ALISO VIEJO, Calif., March 5, 2020 /PRNewswire/ — Okami Medical Inc., a medical device company, announced today the successful completion of the first cases with the LOBOTM Vascular Occlusion System.  The first offering in the company’s product portfolio, LOBO-3, recently received 510(k) […]

Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease

SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, has announced that they have received clearance from the FDA for an expanded indication for the Wingman™ Crossing Catheter after completing the Wing-IT clinical trial. The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip that creates a […]

Access Vascular Receives FDA Clearance For Its HydroPICC Catheter

The HydroPICC Uses Proprietary Technology Designed to Reduce Thrombosis BEDFORD, Mass., Feb. 22, 2018 /PRNewswire/ — Access Vascular, a medical device company reinventing venous access using proprietary material technology designed to reduce thrombus accumulation, announced today that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its […]

Modern Vascular Brings New Treatment Options for Peripheral Artery Disease (PAD) to Denver Residents with the Opening of Its Newest Facility

THORNTON, Colo., March 02, 2020 (GLOBE NEWSWIRE) — Modern Vascular today announced the growth of its national footprint with the opening of a new facility in Thornton, CO, bringing its treatment of Peripheral Artery Disease (PAD) to Denver area residents.  The facility is now open for business and scheduling outpatient […]

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 of the DABRA excimer laser system for use as an […]