Vascular Therapies Announces Preliminary Results From its Phase III AV Fistula Study

CRESSKILL, N.J., Nov. 9, 2017 /PRNewswire/ — An innovative, investigational treatment approach is showing the potential to address an important, unresolved problem encountered by patients with kidney failure on dialysis. At the recent annual meeting of the American Society of Nephrology (ASN), Vascular Therapies, Inc. presented preliminary results relating to […]

Postmarket Surveillance Study Confirms Benefits of Cook Medical’s Zilver® PTX® Drug Eluting Stent at 12 Months in Japanese Patients

LAS VEGAS–(BUSINESS WIRE)–One-year post-market surveillance (PMS) study data from Japanese patients who received the Zilver® PTX® drug-eluting stent confirmed the benefits of the device at 12 months, researchers announced today. Japanese researchers presented the PMS study results at the Vascular Interventional Advances 2014 meeting in Las Vegas. This was the first time the study […]

Symic Bio Announces Results from the Phase 1/2 SHIELD Trial of SB-030 in Peripheral Vascular Disease

SAN FRANCISCO, Nov. 1, 2017 /PRNewswire/ — Symic Bio, a biopharmaceutical company developing novel matrix-targeting biotherapeutics, today announced results from the Phase 1/2 SHIELD trial evaluating SB-030, a locally administered therapeutic, in patients with peripheral vascular disease undergoing angioplasty. In this first-in-human, prospective, randomized, single-blind controlled study of 67 patients, SB-030 demonstrated a […]

Mercator MedSystems Announces Completion of Enrollment in the LIMBO-ATX Trial

EMERYVILLE, Calif., Oct. 30, 2017 /PRNewswire/ — Mercator MedSystems, Inc., a medical technology company specializing in localized delivery of drug therapies for deep in the body, announced completion of enrollment today in the company’s LIMBO-ATX (Lower-Limb Adventitial Infusion of Dexamethasone via Bullfrog to Reduce Occurrence of Restenosis after Atherectomy-Based Revascularization) clinical […]

Nitiloop Announces FDA 510(k) Clearance for its Nova Cross Extreme and Nova Cross BTK Micro catheter for Support of Guidewire Access to Discrete Regions of the Coronary and Peripheral Vasculature

NETANYA, Israel, October 26, 2017 /PRNewswire/ — Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Cross™ Extreme and Nova Cross™ BTK. These dedicated microcatheters are joining the Nova Cross™ product family combining innovative low profile microcatheter technology with uniquely designed Nitinol scaffold providing […]

ACIST Medical Systems Announces Approval and Launch of Next-Generation FFR System

DENVER & EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–ACIST Medical Systems, Inc., a Bracco Group Company, today announced the global launch of its ACIST RXi® Mini™ System, the next generation system of its RXi Rapid Exchange FFR System. The RXi Mini System will debut at the 29th Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium […]

Sub-Lite-Wall® StreamLiner™ Series Poised to Become New Design Standard for Improved Access in Catheter Delivery

ORANGEBURG, S.C., Oct. 24, 2017 /PRNewswire/ — Zeus Industrial Products Inc. (“Zeus”) has released its latest thin-walled PTFE catheter liner as part of their Sub-Lite-Wall® StreamLiner™ series. StreamLiner™ XT, the first offering from the series, was released in July with an impressive maximum wall thickness of 0.00075″ (0.01905 mm). The next in the series, […]

Inari Medical Announces Completion of Patient Enrollment in the FLARE Study for the Treatment of Pulmonary Embolism

IRVINE, Calif., Oct. 24, 2017 /PRNewswire/ — Inari Medical, Inc., a privately held venture backed medical device company dedicated to the development of innovative catheter-based technologies for the treatment of venous thromboembolism (“VTE”), announced today it has completed enrollment of its Investigational Device Exemption (“IDE”) study. The FlowTriever Pulmonary Embolectomy Clinical Study (“FLARE”) […]

Surmodics Announces First Patient Enrolled in TRANSCEND Pivotal Clinical Trial for SurVeil® Drug-Coated Balloon

EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, today announced enrollment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil® drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in […]

Avinger Announces First Patient Enrolled in its IDE Study of the Pantheris Image-Guided Atherectomy System for Treatment of In-Stent Restenosis

REDWOOD CITY, Calif., Oct. 19, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for Peripheral Artery Disease (PAD), today announced initiation of INSIGHT, a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris® Lumivascular Atherectomy System for treating in-stent […]