IVUS

HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

Retrieved on: 
Tuesday, March 26, 2024
Nuclear, Education, Coronary artery disease, Disease, Safety, Partnership, Physiology, Anatomy, Patient, Journal, Biomarker, AI, Death, Plaque, Society, CAD, CCTA, Charleston Area Medical Center, MACE, Cone Health, Collection, FDA, Physician, IVUS, Hospital

The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).

Key Points: 
  • The registry will collect multi-site, real-world information on how the Plaque Analysis product provides enhanced patient insights, empowering physicians and helping to inform their medical management decisions for patients with suspected coronary artery disease (CAD).
  • The DECODE study showed that clinicians using the HeartFlow Plaque Analysis changed their management decisions for 66% of patients compared to CCTA alone across various patient presentations and disease stages.
  • “We believe real-world prospective data from the new DECIDE Registry will empower clinicians with enhanced patient insights leveraging HeartFlow Plaque Analysis to improve patient outcomes.
  • The primary endpoint for this registry will highlight change in medical management after HeartFlow Plaque Analysis compared to after CCTA alone.

Titan Announces Merger Agreement with Conavi

Retrieved on: 
Monday, March 18, 2024
TSX Venture Exchange, Agreement, Health Canada, IP, OCT, RAS, Chairperson, Toronto Stock Exchange, Consolidation, Combined, Reverse, Concurrency, Food, TMD, TSX, Transaction, IVUS, Security (finance)

TORONTO, Ontario, March 18, 2024 (GLOBE NEWSWIRE) -- Titan Medical Inc. (“Titan”) (TSX: TMD; OTC: TMDIF) is pleased to announce that it has entered into a definitive amalgamation agreement (the “Amalgamation Agreement”) dated March 17, 2024 with Conavi Medical Inc. (“Conavi”) to combine the companies in an all-stock transaction.

Key Points: 
  • TORONTO, Ontario, March 18, 2024 (GLOBE NEWSWIRE) -- Titan Medical Inc. (“Titan”) (TSX: TMD; OTC: TMDIF) is pleased to announce that it has entered into a definitive amalgamation agreement (the “Amalgamation Agreement”) dated March 17, 2024 with Conavi Medical Inc. (“Conavi”) to combine the companies in an all-stock transaction.
  • Under the terms of the Agreement, Titan will acquire all of the issued and outstanding shares of Conavi (the “Conavi Shares”) and in exchange Conavi shareholders will be issued common shares of Titan (the “Combined Entity Shares”).
  • Throughout 2023, it was made clear to Titan that a merger with another RAS company was not a viable option and Titan broadened its search for a merger partner beyond RAS.
  • The Titan Board is unanimous in its decision to execute the Amalgamation Agreement and to recommend this Transaction to its shareholders (the “Titan Shareholders”).

Intravascular Ultrasound (IVUS) Global Strategic Analysis Report 2024 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, January 10, 2024
Radiology, Health, Cardiology, Medical Devices, Hospital, Growth, Catheter, Coronary artery disease, Percutaneous coronary intervention, IVUS, COVID-19, Medical ultrasound, PCI, CAD, Intravascular ultrasound, Medical imaging

The "Intravascular Ultrasound (IVUS) - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Intravascular Ultrasound (IVUS) - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
  • This report provides an overview of Medical Ultrasound, with a specific focus on Intravascular Ultrasound (IVUS) and its applications in the medical field.
  • It begins with a general introduction to medical ultrasound and highlights the advantages of ultrasound as compared to other imaging modalities.
  • The report discusses the indications and techniques of Intravascular Ultrasound, providing a comprehensive understanding of its use in medical procedures.

HeartFlow Achieves Landmark Milestone of 250,000 Patients Assessed for Coronary Artery Disease (CAD) with FFRCT Analysis

Retrieved on: 
Wednesday, January 3, 2024
IVUS, Partnership, Risk, CCTA, Physician, FDA, Plaque, CAD, PET, Health, Negative, ACC, Hospital, SCCT, Medicare, Artificial intelligence, EKG, Foreign policy, Growth, Patient, Diagnosis, SPECT

MOUNTAIN VIEW, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary care solutions, today announced that it has surpassed 250,000 patients receiving a HeartFlow FFRCT Analysis.

Key Points: 
  • MOUNTAIN VIEW, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) precision coronary care solutions, today announced that it has surpassed 250,000 patients receiving a HeartFlow FFRCT Analysis.
  • HeartFlow’s FFRCT provides clear insights into each patient’s condition with a patient-specific visual model of the heart’s blood flow.
  • Since its inception, HeartFlow has been committed to building a new standard of care for people at risk of heart disease.
  • “We've experienced a year of notable accomplishments and growth including the expansion of our product portfolio with Plaque Analysis and RoadMapTM Analysis.

Evident Vascular Announces Scientific Advisory Board and New Board Member

Retrieved on: 
Monday, October 30, 2023
Health, Technology, Health Technology, Artificial Intelligence, Cardiology, Biotechnology, Yee, Intelligence, Faculty, FAHA, JD, FSVM, FACC, Manatee Memorial Hospital, LLP, RPVI, Workflow, Master of Science, VIVA, IVUS, Patient, CPO, Diagnosis, Scientific Committee on Emerging and Newly Identified Health Risks, Evidence, MS, Coronavirus Scientific Advisory Board, Management, Medical imaging, MD

Evident Vascular, Inc. a medical technology startup developing a next-generation intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, announced today its Scientific Advisory Board and expansion of its Board of Directors.

Key Points: 
  • Evident Vascular, Inc. a medical technology startup developing a next-generation intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, announced today its Scientific Advisory Board and expansion of its Board of Directors.
  • “It is our privilege to have this esteemed group of clinical experts on our Scientific Advisory Board.
  • “We are also pleased to welcome Bruce Shook to the Evident Vascular Board of Directors.
  • Evident Vascular is developing the first IVUS platform designed for peripheral interventions, with enhanced ease of use and improved image quality.

Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023
Blood vessel, Patient, Angiography, Isabella Tree, Peripheral artery disease, PTA, De novo, Artery, Education, Incidence, DCB, Ioctl, BMI, AVF, CLTI, Kaplan–Meier estimator, Kidney disease, Research, HIV disease progression rates, RCT, Wound healing, BRS, Dialysis, Thrombosis, Clinical trial, Extremities, Risk, Dural arteriovenous fistula, Magnitude, Classification, VIVA, IVUS, Amputation, BTK, PAD, Wynn Las Vegas, Infection, Medical imaging, Pharmaceutical industry, Silviculture

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • Results from Abbott's LIFE-BTK randomized clinical trial (RCT) demonstrate that Esprit BTK (Abbott) reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current state of care.
  • In the LIFE-BTK trial, wound assessment was not a prespecified powered primary or secondary endpoint but rather a prespecified descriptive endpoint.
  • The trial offers the largest ischemic wound data set to date, collected systematically and adjudicated independently in a blinded fashion.

First Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023
Atheroma, Peripheral artery disease, Diabetes, Pivotal trial, Ulcer, Transducer, Male, Disease, PAP, Buerger's test, Classification, The Unreconstructed M, IVUS, Amputation, Stent, PAD, PP, Thorpe tube flowmeter, TUS, Calf, Chin Na, Vein, Telephone, TASC, Bare, Vibrato, Life, SP, W. L. Gore & Associates, VIVA, Safety, Patient, Dyslipidemia, Blood vessel, Plaque, History, CLTI, Coronary artery disease, Perfusion, Restenosis, Research, Foot, Spur, Atherectomy, Șaeș, Artery, Education, DCB, Doppler effect, Dialysis, Hypertension, FP, Freedom, Wynn Las Vegas, Wound healing, Medical imaging, Pharmaceutical industry, Birth control, Surveying, Medtronic

Below are highlights of this morning's 5 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this morning's 5 late-breaking clinical trial presentations.
  • At 20 centers without roll-ins across the United States, 105 no-option CLTI patients were enrolled in a nonrandomized manner.
  • The median age was 70 years, two-thirds of the patients were male, and one-quarter of patients were Hispanic or Latino.
  • 1-Year Results of the DEEPER OUS Trial: The Bare Temporary Spur Stent System in Combination With a Paclitaxel-Coated Balloon
    The DEEPER OUS trial is a prospective, nonrandomized, multicenter, single-arm trial taking place in New Zealand, Germany, and Switzerland.

Evident Vascular Exits Stealth with $35 Million Series A Funding to Develop Intravascular Imaging Platform

Retrieved on: 
Tuesday, October 17, 2023
Health, Medical Devices, Surgery, Health Technology, General Health, Cardiology, Biotechnology, Yee, Intelligence, MD, Moyamoya disease, JD, Thrombectomy, Workflow, Vein, Blood, Clinical trial, Vascular disease, IVUS, Medical imaging

Evident Vascular, Inc. , a medical technology startup developing a next-generation intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, announced today that it has launched with a $35 million Series A financing from Vensana Capital® .

Key Points: 
  • Evident Vascular, Inc. , a medical technology startup developing a next-generation intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, announced today that it has launched with a $35 million Series A financing from Vensana Capital® .
  • “The impetus to launch Evident Vascular was born out of the Vensana team’s extensive experience in the vascular space.
  • Evident Vascular is addressing a critical need in the IVUS market, making it an ideal company to add to our vascular technology innovations.”
    IVUS is a transcatheter intravascular imaging technique used to acquire images from inside blood vessels to evaluate vascular disease and guide interventional treatment.
  • “Legacy IVUS platforms were originally designed primarily for coronary procedures and secondarily for peripheral vascular applications.

Magenta Medical Completes Enrollment to Early Feasibility Study for World's Smallest Heart Pump

Retrieved on: 
Tuesday, August 22, 2023
Heart, Abdominal aortic aneurysm, Cardiogenic shock, Interventional cardiology, Aneurysm, Cardiac catheterization, Northwell Health, Splenic infarction, Quality of life, Nasiriyah Heart Center, Magenta, Artery, Federal, IVUS, Atherosclerosis, Teaching hospital, PCI, North Shore University Hospital, LAD, Mount Sinai Hospital, Patient, Risk, Elevate, St. Francis Hospital, Hospital, Coronary artery disease, FDA, Mount Sinai Health System, Groin, Safety, Pharmaceutical industry, Medical device, Nursing, Cardiology

KADIMA, Israel, Aug. 22, 2023 /PRNewswire/ -- Magenta Medical, developer of the world's smallest heart pump, announced today the completion of enrollment to its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication. All 15 study patients were enrolled and successfully treated at Mount Sinai Hospital, St. Francis Hospital and Heart Center, and North Shore University Hospital. The Elevate™ Early Feasibility Study was approved by the FDA to evaluate the safety and feasibility of the Elevate™ System in providing temporary mechanical circulatory support during HR-PCI procedures, and constitutes the first step in a clinical program intended to secure approval for the device in the US for this indication.

Key Points: 
  • KADIMA, Israel, Aug. 22, 2023 /PRNewswire/ -- Magenta Medical , developer of the world's smallest heart pump, announced today the completion of enrollment to its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) indication.
  • All 15 study patients were enrolled and successfully treated at Mount Sinai Hospital, St. Francis Hospital and Heart Center, and North Shore University Hospital.
  • "Having now used the system in nine complex, high-risk PCI cases, I can truly appreciate its advantages," said Dr. Sharma.
  • The percutaneous Elevate™ heart pump is inserted over a guidewire through commercially available 10 Fr introducer sheaths that require a small puncture in the groin.

New Data from Clinical Studies Further Validate HeartFlow’s All-in-One Portfolio of Precision Coronary Care Solutions

Retrieved on: 
Friday, July 28, 2023
CT, Plaque, Society, Multifocal stenosing ulceration of the small intestine, Anatomy, Society of Cardiovascular Computed Tomography, CAD, Circulant matrix, CCTA, Physiology, Roadmap, IVUS, FFR, Calcium, SCCT, Patient, Risk, Atherosclerosis, Conference, Medical imaging, Pharmaceutical industry

MOUNTAIN VIEW, Calif., July 28, 2023 (GLOBE NEWSWIRE) -- Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of coronary computed tomography angiography (CCTA)-based precision coronary care technologies.

Key Points: 
  • MOUNTAIN VIEW, Calif., July 28, 2023 (GLOBE NEWSWIRE) -- Respective results from the REVEALPLAQUE, DECODE, and SMART-CT clinical studies demonstrate the accuracy, utility, and efficiency of HeartFlow’s portfolio of coronary computed tomography angiography (CCTA)-based precision coronary care technologies.
  • HeartFlow is the first company to offer a suite of technologies to help clinicians non-invasively identify stenoses in the coronary arteries ( RoadMap™Analysis ), assess coronary blood flow ( FFR C T Analysis ), and characterize and quantify coronary atherosclerosis ( Plaque Analysis ).
  • Together, this comprehensive solution offers valuable data not currently available with traditional non-invasive diagnostics tools, allowing clinicians to see the full picture of their patients’ coronary artery disease (CAD).
  • "Until now, clinicians have not had access to a complete view of a patient’s heart health with accurate data on coronary anatomy, physiology, and plaque.