Interventional cardiology

Endovascular Engineering's Hēlo™ Thrombectomy System Receives IDE Approval to Start ENGULF Pivotal Trial for the Treatment of Pulmonary Embolism

Retrieved on: 
Thursday, January 11, 2024
IDE, Coronary thrombosis, Patient, Cardiac catheterization, University, Interventional cardiology, Safety, VTE, MPH, Piedmont Hospital, Pulmonary embolism, Pharmaceutical industry

The approval of the IDE follows the successful completion of the company's 25-patient feasibility study.

Key Points: 
  • The approval of the IDE follows the successful completion of the company's 25-patient feasibility study.
  • "We are excited to be at the forefront of this innovative procedure with the completion of the ENGULF feasibility study.
  • This significant achievement sets the stage for definitive results in the ENGULF pivotal trial.
  • Embarking on our ENGULF pivotal trial is a significant step, further validating the system's safety and efficacy.

Dr. Stephen Oesterle and Dr. Joshua Makower Join Patient Square Capital as Senior Advisors

Retrieved on: 
Thursday, January 4, 2024
Paragon, Acclarent, Mechanical engineering, Health, Yale School of Medicine, Stanford University, Patent, Biological engineering, SVP, Teleflex, Bard (company), Baxter International, MIT, American Institute, MBA, Columbia University, CeramTec, National academy, Mechanical, Yale school, Flexner Report, Friends, Therapy, Invention, Biomedicine, Patient, Harvard Medical School, Hospital, MD, Medtronic, Investment, Harvard College, Interventional cardiology, Nursing

MENLO PARK, Calif., Jan. 4, 2024 /PRNewswire/ -- Patient Square Capital , a leading health care investment firm, today announced that Dr. Joshua Makower and Dr. Stephen Oesterle joined as Senior Advisors to the firm.

Key Points: 
  • MENLO PARK, Calif., Jan. 4, 2024 /PRNewswire/ -- Patient Square Capital , a leading health care investment firm, today announced that Dr. Joshua Makower and Dr. Stephen Oesterle joined as Senior Advisors to the firm.
  • Dr. Makower will also be joining the board of Elevage Medical Technologies, a Patient Square portfolio company focused on growth-stage medical technologies.
  • "Dr. Oesterle and Dr. Makower are undisputed leaders, innovators, and investors in the medical technology space," said Neel Varshney, M.D., Founding Partner of Patient Square.
  • "The resources Patient Square has assembled for the ultimate goal of improving patient outcomes are transformational," added Dr. Oesterle.

Laguna Tech USA Announces Site Record Number of Transcatheter Heart Valves Implanted at Single Center on Same Day in First-in-Human Clinical Trial

Retrieved on: 
Wednesday, January 3, 2024
Calcification, Fluoroscopy, University, Aortic regurgitation, Tricuspid valve, Calcium, ALPHA, Heart, Engineering, Aortic valve, Patient, Interventional cardiology, Medical device

All five implants were accomplished on the same day at the Instituto Nacional de Torax in Santiago, Chile within the ongoing feasibility trial for the ZETA system.

Key Points: 
  • All five implants were accomplished on the same day at the Instituto Nacional de Torax in Santiago, Chile within the ongoing feasibility trial for the ZETA system.
  • The ZETA system is a novel balloon-expandable transcatheter valve with six expanding arms and a low profile covered delivery system.
  • Additionally, by fluoroscopy, all implanted ZETA valves were consistently implanted within two millimeters of the annulus.
  • We look forward to scaling this technology and moving into later stage clinical development so we can bring this technology to a greater population of patients.”

BioCardia Doses First Patient in CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells for the Treatment of Ischemic Heart Failure of Reduced Ejection Fraction

Retrieved on: 
Tuesday, December 19, 2023
Immunosuppression, Culture, Partnership, Division, Risk, Data monitoring committee, Vascular disease, TRIDENT, University of Florida, MD, Microsoft Exchange Server, Heart, University, BCDA, Patient, Interventional cardiology, NCT, Clinical, Therapy, MSC, Heart failure, Principal investigator, Pharmaceutical industry

These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.

Key Points: 
  • These proprietary CardiALLO human cells and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California.
  • We look forward to continuing this close partnership as we actively enroll additional patients in the CardiALLO MSC Study.
  • The CardiALLO MSC trial builds on the compelling early signals for benefit demonstrated in these previous trials.
  • The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT, NCT00768066),
    The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (POSEIDON, NCT01087996),
    The Transendocardial Stem Cell Injection Delivery Effects on Neomyogenesis Study (TRIDENT, NCT 02013674)

Microbot Medical and Corewell Health Forge Collaboration to Establish the LIBERTY® Endovascular Robotic Surgical System for Telerobotic

Retrieved on: 
Thursday, December 14, 2023
Physician, Robotics, Hospital, Nursing, Patient, Interventional cardiology

BRAINTREE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced it has entered into a collaboration agreement with Corewell Health™.

Key Points: 
  • BRAINTREE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced it has entered into a collaboration agreement with Corewell Health™.
  • The objective of the collaboration, which will take place in multiple phases, is to enable telerobotics between remote centers by utilizing the LIBERTY Endovascular Robotic Surgical System.
  • The agreement with Corewell Health includes the right to mutually evaluate the LIBERTY System for remote procedures, which will be led by Ryan Madder, M.D., an expert in interventional cardiology.
  • "We are excited for the opportunity to collaborate with Corewell Health and Dr. Ryan Madder, innovators in the field of robotics and healthcare.

Teleflex Announces First Patient Enrollment in ACCESS-MANTA™ Registry

Retrieved on: 
Thursday, November 16, 2023
TAVR, Safety, NYSE, TFX, Cardiology, Structural heart disease, Patient, Registry, Interventional cardiology, Intervention, Hemostasis, SAFE, Teleflex, Doctor of Philosophy, Mount Sinai Medical Center, VCD, Mount Sinai Hospital (Manhattan), Medical device, Medical imaging, Hospital, Surgery, MD

The registry will include appropriate patient selection and proper vascular access.

Key Points: 
  • The registry will include appropriate patient selection and proper vascular access.
  • Enrolling at least 250 patients in up to 15 major TAVR institutions across the US and Canada, the ACCESS-MANTA™ Registry is an international, multicenter, prospective, observational, single-arm clinical registry.
  • “Large bore access site complications are recognized as morbid,1 driving increased costs and prolonged length-of-stay,2” said Teleflex Interventional Medical Director, Christopher Buller, MD.
  • “We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA™ Registry,” said Dr. Khera, Co-Global Principal Investigator.

ReValve Solutions Announces Successful First-in-Human with Next Generation TMVR Technology

Retrieved on: 
Wednesday, November 29, 2023
Health, Medical Devices, Surgery, Health Technology, Clinical Trials, Cardiology, Biotechnology, LVOT, East Carolina University, Medical director, Chair, TMVR, Mitral regurgitation, History, Patient, Heart, Northwestern Memorial Hospital, Male, Interventional cardiology, Heart failure, Tricuspid valve, Mitral valve, Retail Solutions Inc., University, Patent, Medical device

ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.

Key Points: 
  • ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.
  • ReValve’s technology is designed to replace the Mitral Valve while also preserving the heart’s natural basal left ventricular function.
  • Our flexibility and four-point securement system provide a patent LVOT and maintains left ventricular function throughout recovery,” said Julie Logan Sands, Founder and CEO ReValve Solutions.
  • ReValve’s first-of-its-kind TMVR is thoughtfully designed to expand the treatable population of patients suffering from Mitral Valve Disease,” added Sands.

Dr. David Shavelle Named Chief of Cardiology at MemorialCare - Serving as Liaison Between Hospital Administration, Medical Staff and Clinical Leaders

Retrieved on: 
Thursday, December 14, 2023
UCLA, USC, Joint Medical Service (Germany), Harbor, Research, Private practice, Good Samaritan Hospital, Scar, Mechanical engineering, Patient, Catheter, Faculty, Division, Heart, Interventional cardiology, Internal medicine, Caregiver, Rehabilitation, Health, Intervention, Golden Apple Award, Los, University, Physician, UC, Golden Apple Award (education), Harbor–UCLA Medical Center, Mechanical, University of California, Irvine, Education, Medical imaging, Cardiology

FOUNTAIN VALLEY, Calif., Dec. 14, 2023 /PRNewswire/ -- MemorialCare, a prominent nonprofit Southern California integrated health system, announced today that David Shavelle, M.D. has been named the Chief of Cardiology for the entire health system. In his new role, Dr. Shavelle will serve as a liaison between Los Angeles' and Orange County's medical staffs, hospital administrations, physicians and clinical teams across MemorialCare's entire footprint – advancing the vision and mission of the MemorialCare Heart & Vascular Institute throughout the health system.

Key Points: 
  • has been named the Chief of Cardiology for the entire health system.
  • Dr Shavelle will be responsible for leading MemorialCare Heart & Vascular Institute's general and specialty cardiology, interventional cardiology, advanced interventional modalities such as structural heart, complex coronary, ventricular support, research, and clinical trials system wide.
  • Dr. Shavelle will also keep his current role as medical director of adult cardiology and interventional lab, at MemorialCare Long Beach Medical Center.
  • "I am humbled and honored to become the Chief of Cardiology for MemorialCare," says Dr. Shavelle.

Flourish Research Expands with opening of new site Bowie

Retrieved on: 
Monday, December 11, 2023
DRS, Association of Black Cardiologists, Research, De novo, Cardiology, Interventional cardiology, Cultural diversity, Doctor of Philosophy, Physician, Nursing, MD, Flourish

NEW YORK, Dec. 11, 2023 /PRNewswire-PRWeb/ -- Flourish Research announces the opening of a new Cardiology research site. Flourish - Bowie is in the metropolitan area of Baltimore, MD, and Washington DC, and expands the company's cardiovascular and metabolic therapeutic areas under the leadership of cardiologists, Barbara Hutchinson MD, PhD and Sarah Collins, MD. Dr. Hutchinson is the Chairwoman of the Board for the Association of Black Cardiologists and her practice, Chesapeake Cardiac Care, has been serving a diverse patient population since its founding in 2003.

Key Points: 
  • Flourish Research announces the opening of Flourish-Bowie, a new Cardiology research site in the metropolitan area of Baltimore, MD, and Washington DC.
  • NEW YORK, Dec. 11, 2023 /PRNewswire-PRWeb/ -- Flourish Research announces the opening of a new Cardiology research site.
  • Flourish - Bowie is in the metropolitan area of Baltimore, MD, and Washington DC, and expands the company's cardiovascular and metabolic therapeutic areas under the leadership of cardiologists, Barbara Hutchinson MD, PhD and Sarah Collins, MD.
  • Flourish Research is committed to improving diversity in clinical research and with the help of the Association of Black Cardiologists we are proud to launch our first De Novo site, bringing us closer to accomplishing this goal."

Argon Medical Launches Kodiak™ Dual Port Coaxial Introducer Kit for Complex Vascular Procedures

Retrieved on: 
Thursday, November 30, 2023
Interventional radiology, Dual-ported video RAM, Senior, Complex, Patient, Global marketing, Interventional cardiology, Caregiver, Argon, Vascular surgery, Physician, IVC, Medical imaging, Oncology

PLANO, Texas, Nov. 30, 2023 /PRNewswire/ -- Argon Medical Devices, a leading provider of device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology, announced the launch of the Kodiak™ Dual Port Coaxial Introducer Kit for precise and streamlined introduction of diagnostic and therapeutic devices into the vasculature.

Key Points: 
  • PLANO, Texas, Nov. 30, 2023 /PRNewswire/ -- Argon Medical Devices, a leading provider of device solutions for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology, announced the launch of the Kodiak™ Dual Port Coaxial Introducer Kit for precise and streamlined introduction of diagnostic and therapeutic devices into the vasculature.
  • The Kodiak Dual Port Coaxial Introducer Kit is engineered for versatility, as it applies to various vascular procedures.
  • In doing so, Kodiak can simplify complex procedures where the rigor of the procedures demands a robust device to provide treatment efficiently.
  • "The Kodiak Dual Port Coaxial Introducer Kit offers unmatched versatility and robustness, applicable to a variety of complex endovascular procedures that require simultaneous introduction of multiple components into the vasculature.