6 minute read
VenoValve
First-in-human patients continue to benefit from VenoValve at average of three years post-surgery, new data show
Positive long-term, three-year observational data from a cohort of patients that participated in the previously concluded VenoValve (Envveno Medical) first-inhuman clinical trial were recently presented at the VEITHsymposium 2022 (Nov. 15–19) in New York City.
Principal investigator Jorge Hernando Ulloa, MD, from University of the Andes in Bogota, Colombia, reported that the VenoValve patients, who are now an average of 36 months post VenoValve implantation, continue to benefit from the VenoValve and have experienced no relapses of severe chronic venous insufficiency (CVI) and no recurrences of venous ulcers. Safety events were limited to one thrombosis after discontinuation of anticoagulation medication.
The presenter added that average improvements in reflux, CVI disease manifestations (revised Venous Clinical Severity Score [rVCSS]), and pain (Visual Analog Scale [VAS]) remained stable at 63%, 52%, and 84% respectively, when compared to pre-surgery levels, for the cohort of eight patients that agreed to be followed at conclusion of the one-year first-in-human trial. One patient experienced an increase in rVCSS due to dermatitis, which Ulloa noted was unrelated to the VenoValve or vascular disease.
A company press release details that the VenoValve is a first-in-class, surgically implanted replacement venous valve that is currently being evaluated in the SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial—a prospective, non-blinded, single-arm, multicenter study of 75 CVI patients.
VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. Envveno Medical estimates that approximately 2.5 million people in the U.S. that suffer from the debilitating impacts of severe deep venous CVI would be candidates for implantation of the VenoValve device.
VenoValve
Viz.ai announces positive new data from large aortic dissection AI realworld study
VIZ.AI RECENTLY ANNOUNCED NEW
data from a large aortic dissection artificial intelligence (AI) real-world study that supports the use of its AI technology for the detection of suspected aortic dissection.
Data from the new study, which were presented this week at VEITHsymposium 2022 (Nov. 15–19) in New York City, validate the Viz.ai’s dissection detection algorithm, according to the company.
An abstract from Viz.ai, in collaboration with Avicenna.ai, entitled “Real-world validation of a deep learning AI-based detection algorithm for suspected aortic dissection,” reported the performance of the Viz Aortic Dissection Algorithm on 1,303 computed tomography (CT) angiography scans collected from over 200 U.S. cities.
The algorithm demonstrated a sensitivity of 94.2%, specificity of 97.3%, as well as a positive predictive value of 80.1% and negative predictive value of 99.3%.
The authors concluded: “These findings provide significant real-world validation of a deep-learning AI-based detection algorithm for suspected aortic dissection. Automated detection may have a positive downstream effect on patient triage leading to accelerated care coordination, earlier diagnosis, timely initiation of life-saving interventions, and better patient outcomes.”
According to a company press release, Viz Aortic accelerates time-to-notification to specialists giving them access to clinically-relevant imaging and patient information for appropriate patient treatment plans.
The solution includes AI-powered alerts, high-fidelity mobile image viewing, relevant clinical information, and HIPAA-compliant communication to facilitate workflow and improve patient care for all aortic conditions. Meanwhile, Viz.ai recently announced a partnership with Illuminate, a developer of proprietary natural language processing (NLP) and AI software that discovers at-risk patients from electronic medical records (EMR), assesses disease severity, and facilitates follow-up surveillance for a variety of diseases.
The partnership will enable healthcare providers to make timely, critical decisions for aortic aneurysm patients while improving compliance with pre- and post-surgical surveillance programs, the company said in a press release.
INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm – 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation. CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.
INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions up to 80 mm in length with reference vessel diameters ranging from 4.0 – 12 mm. The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is also indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts. CONTRAINDICATIONS: The GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system. Do not use the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available.
* As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface.
Products listed may not be available in all markets. CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc. GORE, Together, improving life, VBX, VIABAHN and designs are trademarks of W. L. Gore & Associates. © 2022 W. L. Gore & Associates, Inc. 22689847-EN NOVEMBER 2022
COVERED STENTS OFFER PROMISING ADVANTAGES
for treating complex iliac occlusive disease
The GORE® VIABAHN® Device family of covered stent grafts gives you the flexibility and conformability to safely and confidently address even the most complex cases.1,2,*
HIGHER PATENCY RATES AT THE AORTIC BIFURCATION3 P = .023
Patency rates
92%
78%
Covered stents
Bare metal stents One-year
92%
62%
Covered stents
Bare metal stents Two-year
See all the data
Balloon expandable covered iliac kissing stents versus bare metal stents at the aortic bifurcation
* The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis indication includes de novo or restenotic lesions in iliac arteries, including those at the aortic bifurcation. The GORE® VIABAHN® Endoprosthesis indication includes lesions in the iliac arteries only. 1. Piazza M, Squizzato F, Dall’Antonia A, et al. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. 2. Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable
Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736. 3. Sabri SS, Choudhri A, Orgera G, et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. Journal of Vascular & Interventional Radiology 2010;21(7):995-1003. Please see accompanying prescribing information in this journal. Products listed may not be available in all markets. GORE, Together, improving life, VBX, VIABAHN and designs are trademarks of W. L. Gore & Associates. ©2022 W. L. Gore & Associates, Inc. 22470700-EN JULY 2022
