Peripheral/Endo

Proximo Medical Expands Portfolio with PEDRA™ Technology

Novel technology designed to provide real-time perfusion monitoring CASTLE PINES, Colo., Nov. 13, 2019 /PRNewswire/ — Proximo Medical, LLC today announced a partnership with PEDRA™ Technology, a Singapore based medical device innovator focused on the treatment of peripheral artery disease (PAD), for marketing and commercialization of its perfusion monitoring technology. Proximo Medical is a fractional commercial organization […]

PENUMBRA INDIGO® ASPIRATION SYSTEM IDE TRIAL FOR ACUTE PULMONARY EMBOLISM MEETS PRIMARY SAFETY AND EFFICACY ENDPOINTS

Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting LAS VEGAS – November 6, 2019 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo® […]

Intact Vascular Announces Positive Six-Month Data from TOBA II BTK Clinical Trial During Late-Breaking Session at 2019 VIVA Conference

First-of-its-Kind Pivotal Study of the Tack Endovascular System® Demonstrates 100% Dissection Resolution in Challenging Below-the-Knee Disease WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive six-month results of its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial, successfully achieving all primary (P < 0.0001) […]

LimFlow Announces Positive Six-Month Data From Promise I U.S. Early Feasibility Study Demonstrating Excellent Amputation Free Survival and Wound Healing in No-Option Patient Population

Results Presented Today at Vascular Interventional Advances (VIVA) Conference PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), today announced the presentation of positive six-month data from the full patient cohort in […]

Boston Scientific Announces Positive Data for the Ranger™ Drug-Coated Balloon and the Eluvia™ Drug-Eluting Vascular Stent at VIVA19

Late-breaking clinical trial data demonstrate high rates of primary patency and significantly lower rates of clinically-driven target lesion revascularization for peripheral drug-eluting device portfolio LAS VEGAS and MARLBOROUGH, Mass., Nov. 5, 2019 /PRNewswire/ — Today, Boston Scientific (NYSE: BSX) announced positive data for two devices within the peripheral drug-eluting product portfolio during separate late-breaking clinical […]

Okami Medical Announces Major Milestones: FDA 510(k) Clearance And Key Patent For The LOBO Vascular Occluder

Microcatheter-delivered device designed to provide rapid and focal occlusion of a wide range of peripheral arterial targets ALISO VIEJO, Calif., Nov. 4, 2019 /PRNewswire/ — Okami Medical Inc., a medical device company, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and initial launch of the LOBOTM Vascular Occlusion System. […]

CORRECTING and REPLACING PHOTO PQ Bypass Initiates Pivotal Study of Next-Generation Advancement in Stent Graft Technology for Treatment of Patients with Peripheral Artery Disease

MILPITAS, Calif.–(BUSINESS WIRE)–Please replace the photo with the accompanying corrected photo. The release reads: PQ Bypass, Inc., a clinical-stage medical device company, today announced it has enrolled the first patient in its TORUS 2 multi-center clinical trial of its self-expanding TORUS® stent graft system, a novel technology designed for the […]

Shockwave Announces Commercial Availability of Below-the-Knee IVL Catheter

Shockwave S4 Catheter Expands the Intravascular Lithotripsy System Portfolio to Address the Challenges of Critical Limb Ischemia SANTA CLARA, Calif., Nov. 04, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today announced commercial availability of […]

Ra Medical Systems Announces Substantial Completion of Audit Committee Investigation

CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focusing on commercializing excimer laser systems to treat vascular and dermatological diseases, today announced that the Audit Committee of the Board of Directors (the “Audit Committee”) has substantially completed its internal investigation, which was originally announced in August. […]

Medtronic Announces Shonin Approval and Launch of the Valiant Navion™ Thoracic Stent Graft System in Japan

Lower-Profile Thoracic Endovascular Aortic Repair (TEVAR) Device Continues to Broaden Global Treatable Patient Population with Thoracic Aortic Disease DUBLIN, Oct. 31, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) and the launch of the Valiant Navion™ thoracic stent graft system […]