vascular system News
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BioMimics 3D Vascular Stent System granted Shonin in Japan – December 2019
The BioMimics 3D Vascular Stent System received Shonin regulatory approval in Japan. On December 19th, 2019, Japanese MHLW PMDA granted Marketing Pre-Market Approval (“Shonin”) for BioMimics 3D Vascular Stent System to improve luminal diameter during endovascular intervention in patients with symptomatic peripheral arterial disease in the femoropopliteal artery. The approved ...
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BioMimics 3D, a next generation biomimetic peripheral stent, now available nationwide with Veryan Medical and Premier collaboration
HORSHAM, UK – 01 MAY 2022 – Veryan Medical Inc. has been awarded a group purchasing agreement for Peripheral and Biliary Stents with Premier, Inc. Effective 01 May 2022, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the BioMimics 3D Vascular Stent ...
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OSHwiki article in the spotlight - How to prevent musculoskeletal disorders (MSDs) in the healthcare sector
Musculoskeletal disorders (MSDs) encompass health problems relating to muscles, tendons, the skeleton, cartilage, ligaments, nerves or the peripheral vascular system. They are the leading cause of work-related health problems in the healthcare sector, which accounts for 10 % of the overall workforce in Europe. A new OSHwiki article on the topic explains the scale of the problem, the risk factors ...
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36-month results from Veryan Medical’s MIMICS-2 study at CX 2020 Live
Professor Thomas Zeller (University Heart Centre Freiburg, Bad Krozingen, Germany) today presented the 36-month results from Veryan Medical’s MIMICS-2 study at CX 2020 Live. MIMICS-2 is a prospective, single-arm, multi-centre clinical study to evaluate the safety and effectiveness of the BioMimics 3D® Vascular Stent System in the treatment of patients with symptomatic atherosclerotic ...
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New Multi-Organ-Chip project towards vaccine & drug candidate testing for Tuberculosis
TissUse will receive funding from the Bill & Melinda Gates Foundation to develop a human preclinical lung-liver-lymph node co-culture on a HUMIMIC Chip infectable with Mycobacterium tuberculosis. This collaboration will contribute to the development of Tuberculosis vaccine candidates and treatment modalities. TissUse announced today that it has received funding from the Bill & Melinda ...
By TissUse GmbH
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BioMimics 3D US launch
Veryan Medical (Horsham, UK) today announced that it has launched the innovative BioMimics 3D Vascular Stent System in the US. The BioMimics 3D self-expanding, nitinol stent features a highly-differentiated, helical centre-line design that has achieved excellent clinical outcomes in clinical trials, including a pivotal study with 3-year follow-up. 01 September 2020 Nick Yeo, Veryan’s CEO ...
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First-in-Human Trial Evaluates Safety and Efficacy of Rex Medical`s Large Bore Closer System
November 7, 2018 — At VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada, Micah Watts, MD, presented findings from the first-in-human clinical trial of the Large Bore Closer vascular sealing system (Rex Medical). The trial evaluated 23 patients at a single site and assessed the safety and effectiveness of the Large Bore Closer ...
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CD Bioparticles Introduces Hydrophilic Coatings for Medical Applications
CD Bioparticles, a leading manufacturer and supplier of various drug delivery products and services, recently introduced hydrophilic coatings and related services for medical applications, which can be used within interventional medical devices of the cardiovascular, circulatory, nervous, urinary, and vascular system. Functional medical coatings are a class of interface materials applied to the ...
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Cardiva Medical Announces First Patients Enrolled in The AMBULATE Same Day Discharge Study Using VASCADE MVP
SANTA CLARA, Calif., July 16, 2020 -- Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced the first patient enrollments in its AMBULATE Same Day Discharge study, the first prospective multi-center study designed to evaluate same-day discharge for patients undergoing cardiac ablation procedures for atrial fibrillation. The study is utilizing the VASCADE MVP Venous ...
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New Study Shows Advantages of Ellipsys System in Safely and Quickly Creating Reliable Dialysis Access
A new study shows significant benefits of the Ellipsys Vascular Access System in easily and safely creating durable vascular access for end-stage renal disease (ESRD) patients who require hemodialysis. It also offers a standardized process for using the minimally invasive technology that other physicians can follow to reproduce the results, which “will make it easier for more practitioners ...
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FDA Clears Rex Medical Bioresorbable Vascular Closure Device
August 3, 2016 — The U.S. Food and Drug Administration (FDA) has granted market clearance to Rex Medical’s bioresorbable Closer Vascular Sealing System (VSS) to achieve rapid hemostasis of femoral artery catheterizations. The vascular closure device consists of an insertion sheath, dilator and an implant contained in a delivery system. It uses a patch placed against the artery wall ...
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B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent Please ReX Drug Coated PTCA Balloon Catheter
B. Braun Interventional Systems Inc. (BIS) announced today that they will collaborate with Infraredx, a Nipro Company, to accelerate the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial for the B. Braun SeQuent Please ReX Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation in late 2019. This announcement furthers the ...
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Okami Medical Announces FDA 510(k) Clearance of the LOBO-5 Vascular Occluder
Aliso Viejo, CA- December 16, 2020 – Okami Medical Inc., a medical device company, today announced the expansion of its LOBO™ Vascular Occlusion System product line with the U.S. FDA 510(k) clearance of the LOBO-5 Vascular Occluder. The LOBO (LOw-profile Braided Occluder) system is uniquely designed to provide interventional physicians with a single-device, ...
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AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a ...
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Ellipsys System Offers Significant Advantages for Creating Dialysis Access, Physicians Say
The Ellipsys® Vascular Access System enables patients with kidney failure to start dialysis treatment sooner with fewer procedures, complications and interventions compared to surgery, according to several leading physicians who spoke at the recent meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN). Interventional radiologist Jeffrey Hull, M.D., was awarded ...
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New respiratory multitest
The new Vitassay SARS-CoV-2 + Flu A + B + RSV + Adeno Resp. is a rapid, immunochromatographic assay for the simultaneous qualitative detection of nucleoprotein antigen of SARS-CoV-2, Influenza type A, Influenza type B, RSV and Adenovirus from nasopharyngeal swabs samples from patients suspected of COVID-19 infection and/or Influenza A and/or Influenza B and/or Respiratory Syncytial Virus (RSV) ...
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Cardiva Medical Announces $45 Million Financing Led by EW Healthcare Partners
SANTA CLARA, Calif., July 14, 2020 (GLOBE NEWSWIRE) -- Cardiva Medical, Inc, an innovator in the field of vascular closure, today announced the completion of a $45 million equity financing round. The equity round included new investor EW Healthcare Partners in addition to Cardiva Medical’s existing major investors, including affiliates of Luther King Capital Management, PTV Healthcare ...
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Longeveron Announces Initiation of Phase 2a Clinical Trial of Lomecel-B for the Treatment of Alzheimer’s Disease
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or the "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today the initiation of its Phase 2a clinical trial evaluating Lomecel-B as a treatment for Alzheimer’s disease (AD). The first patient has consented to participate in the trial and ...
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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, CA – November 4, 2019 – 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 LOBO™ Vascular Occlusion System. The Company further announced ...
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Okami Medical Announces First Patients Treated With The LOBO Vascular Occluder
ALISO VIEJO, CA, March 5, 2020 — Okami Medical Inc., a medical device company, announced today the successful completion of the first cases with the LOBO™ Vascular Occlusion System. The first offering in the company’s product portfolio, LOBO-3, recently received 510(k) clearance from the U.S. Food and Drug Administration for the occlusion of peripheral arteries. The LOBO ...
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