Vascular surgery

Shape Memory Medical Announces First Patient Treated in the AAA-SHAPE Randomized Controlled Pivotal Trial

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星期一, 六月 3, 2024
Science, Cardiology, Biotechnology, Research, Surgery, Health, Medical Devices, Clinical Trials, MD, Patient, Vascular surgery, Indiana University, Trial of the century, Safety, EVAR, Area studies, CE, Abdominal aortic aneurysm, Randomized controlled trial, Aneurysm, Expansion, Blood, Federal, Mortality, AAA, Neurovascular bundle, PMDA, Medical imaging

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).

Key Points: 
  • Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the first patient treated as part of the AAA-SHAPE Pivotal Trial, the Company’s prospective, multicenter, randomized, open-label trial to determine safety and effectiveness of the IMPEDE-FX RapidFill® Device to improve abdominal aortic aneurysm (AAA) sac behavior when used with elective endovascular aneurysm repair (EVAR).
  • “We would like to congratulate Dr. Motaganahalli and the clinical study team at Indiana University for being the first to enroll a patient in the AAA-SHAPE Pivotal Trial.
  • IMPEDE-FX RapidFill, the investigational device, incorporates Shape Memory Medical’s novel shape memory polymer, a proprietary, porous, radiolucent, embolic scaffold that is crimped for catheter delivery and self-expands upon contact with blood.
  • Prior to the AAA-SHAPE Pivotal Trial, the AAA-SHAPE early feasibility studies enrolled a combined 35 patients in New Zealand and the Netherlands.

Prospective Study Shares Early Clinical Experience with Shape Memory Polymer Vascular Plugs for Pelvic Venous Disease

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星期一, 五月 13, 2024
General Health, Surgery, Medical Devices, Infectious Diseases, Health, Patient, Doctor of Philosophy, Female, European Journal, CPP, Leal, Vascular surgery, Magnetic resonance, Blood, Pelvic pain, PVD, Gynaecology, Interventional radiology, University of Navarra, Chronic pain, Woman, Pain, Multimedia, Memory, Birth control

Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the publication of a prospective observational study looking at the use of a single shape memory polymer plug, the IMPEDE-FX Embolization Plug, as the embolization agent to treat female pelvic venous disease (PVD).

Key Points: 
  • Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced the publication of a prospective observational study looking at the use of a single shape memory polymer plug, the IMPEDE-FX Embolization Plug, as the embolization agent to treat female pelvic venous disease (PVD).
  • In this prospective, observational case series, Jose Ignacio Leal Lorenzo, MD, PhD, and lead author, reports encouraging outcomes in this early experience.
  • Early Experience on Embolisation of Female Pelvic Venous Disease With a Single Shape Memory Vascular Plug: A Prospective Magnetic Resonance Imaging Based Evaluation, published by Leal et al, is available via open access at https://authors.elsevier.com/a/1iutJ3rFXltnme .
  • For more information about Shape Memory Polymer for Pelvic Venous Disorders, visit www.shapemem.com/pelvic-health .

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

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星期五, 三月 22, 2024
Diagnosis, Research, U.S. FDA, Peripheral artery disease, Infection, Patent, Buddha's hand, Evaluation, PAD, Journal, Sale, University, Doctor of Philosophy, Efficacy, Priority review, Regenerative medicine, Clinical trial, Trial of the century, Vascular surgery, HAV, Hospital, Injury, Nationwide Children's Hospital, HUMA, FACS, Amputation, Food, FDA, Defense, BLA, PDUFA, Pharmaceutical industry

DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.

Key Points: 
  • There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
  • Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
  • General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
  • The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.

Silk Road Medical Expands TCAR® Portfolio with Launch of Tapered ENROUTE® Transcarotid Stent System

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星期二, 三月 5, 2024
FACS, Hospital, MD, CEA, Professor, Physician, Vascular surgery, Stroke, Plaque, MBA, Risk, Cooper University Hospital, Silk, Patient, Anatomy, TCAR, Stenosis, SILK, Pharmaceutical industry

This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.

Key Points: 
  • This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.
  • “New tapered configurations for our ENROUTE Transcarotid Stent System build upon the robust portfolio of Silk Road’s carotid solutions.
  • The ENROUTE Transcarotid Stent System features an optimized cell design balancing lesion coverage and anatomical conformability for long-term plaque stabilization.
  • The stent system was purpose-built for TCAR with a short delivery system for ergonomic and precise stent delivery.

Healthy.io and Johns Hopkins Collaborate to Utilize New Patient-Facing Technology to Improve Wound Care Management

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星期四, 三月 7, 2024
Diabetes, Caregiver, Telehealth, Vascular surgery, Manuscript, Communication, Risk, Amputation, Frontiers, Johns Hopkins, COVID-19, Prediabetes, Patient, Privacy, DFU, CDC, Research, Johns Hopkins Hospital, Wound healing, Nursing

BOSTON, March 7, 2024 /PRNewswire/ -- Healthy.io, the global leader in transforming the smartphone camera into a medical device, is launching a groundbreaking program utilizing smartphone-based technology to improve wound care management for patients suffering from chronic diabetic wounds. This pilot program expands access to Healthy.io's Minuteful for Wound solution to patients in the division of Vascular Surgery and Endovascular Therapy department at the Johns Hopkins Hospital.

Key Points: 
  • This pilot program expands access to Healthy.io's Minuteful for Wound solution to patients in the division of Vascular Surgery and Endovascular Therapy department at the Johns Hopkins Hospital.
  • Diabetes and chronic wounds are often connected, with 19-33% of patients with diabetes developing diabetic foot ulcers (DFU) or other chronic wound conditions in their lifetime.
  • Despite health systems' enthusiasm for telemedicine after the COVID-19 pandemic, research documenting the impact of patient-centered technologies on wound care is scarce.
  • "We are thrilled to be collaborating with Johns Hopkins to utilize this innovative technology, which empowers patients and their caregivers to take an active role in their wound care management," said Geoff Martin, CEO of Healthy.io.

Illuminate Announces Results of New Live Saving Thoracic Aortic Aneurysm Surveillance Program

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星期二, 二月 20, 2024
Thoracic aortic aneurysm, TAA, Vascular surgery, Discovery, Risk, Society, UC, University of California, Davis, Health, Patient, AAA, Illuminate, Leakage, Abdominal aortic aneurysm, Medical device

OVERLAND PARK, Kan., Feb. 20, 2024 /PRNewswire/ -- Softek Illuminate, Inc., provider of enterprise follow-up management and discovery software, and UC Davis Health have developed a centralized Thoracic Aortic Aneurysm (TAA) surveillance program that is saving lives. The effort has identified at-risk patients who may have been 'lost-to-follow-up' because they missed care due to numerous factors.

Key Points: 
  • OVERLAND PARK, Kan., Feb. 20, 2024 /PRNewswire/ -- Softek Illuminate, Inc. , provider of enterprise follow-up management and discovery software, and UC Davis Health have developed a centralized Thoracic Aortic Aneurysm (TAA) surveillance program that is saving lives.
  • This new program builds on the previously announced success between Illuminate and UC Davis Health with a centralized Abdominal Aortic Aneurysm (AAA) program.
  • This new TAA program will further advance efforts to make it easier for care navigators to manage vascular patients with critical follow-up care requirements.
  • Their participation can lower the barrier for implementing a comprehensive aneurysm surveillance program and ensure the following benefits are realized:
    Align follow-up care with health system care guidelines.

State-of-the-Art Vascular Surgery Practice Expands Its Physician Partners

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星期四, 二月 15, 2024
Surgery, Health, Other Health, Newton-Wellesley Hospital, Multimedia, Patient satisfaction, Physician, Public health, Hospital, Vascular surgery, Priscilla Chan, Harvard University, Vein, Nursing care plan, Safety, University, Moyamoya disease, Emory University, Ischemia, Varicose veins, Public, Patient, Medicine, Massachusetts General Hospital, Stenosis, Research, Partnership, Medical device

Both Dr. Arous and Dr. Lancaster take a comprehensive approach to vascular health, and their commitments to advancing patient outcomes have earned them reputations as thoughtful leaders in the field.

Key Points: 
  • Both Dr. Arous and Dr. Lancaster take a comprehensive approach to vascular health, and their commitments to advancing patient outcomes have earned them reputations as thoughtful leaders in the field.
  • Including Dr. Arous and Dr. Lancaster as partners underscores TVCG’s dedication to staying at the forefront of vascular surgery and medicine.
  • Chan School of Public Health, and underwent vascular and endovascular surgery training at Massachusetts General Hospital.
  • Dr. Lancaster serves as the chief of Vascular Surgery and other leadership roles at Newton-Wellesley Hospital.

Healthgrades Names 2024 America's Best Hospitals

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星期二, 一月 23, 2024
Patient, Statistics, Prostatectomy, Hospital, Vascular surgery, MD, Medicare, Healthgrades, Methodology, Critical care, Orthopedic surgery, Cardiology, PCI, Da Vinci Surgical System, Data science, Nursing

DENVER, Jan. 23, 2024 /PRNewswire/ -- Healthgrades , the #1 site Americans use to find a doctor or hospital, today announced the recipients of the 2024 America's Best Hospitals Awards and State Rankings.

Key Points: 
  • DENVER, Jan. 23, 2024 /PRNewswire/ -- Healthgrades , the #1 site Americans use to find a doctor or hospital, today announced the recipients of the 2024 America's Best Hospitals Awards and State Rankings.
  • To determine the top 250 U.S. hospitals, Healthgrades evaluated clinical performance for approximately 4,500 hospitals across more than 30 common procedures and conditions.
  • In tandem with this national recognition, Healthgrades measured the hospitals across 18 key specialty areas* to identify the highest-ranking hospitals in 32 eligible states.
  • **
    The complete list of 2024 America's Best Hospitals and its detailed methodology are available on Healthgrades.

Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma

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星期五, 十一月 17, 2023
Sale, Efficacy, Food, Extremities, BLA, Ernest, Denver Health Medical Center, Risk, Surgeon, Clinical trial, Meta-analysis, Amputation, Constipation, Peripheral artery disease, HAV, Thrombocytopenia, Research, Death, FDA, FACS, Army, HUMA, Standard of care, Infection, File, University, Tachycardia, Vascular surgery, Doctor of Philosophy, Anemia, Evaluation, Common, Biologics license application, Saphenous, Injury, Trial of the century, Pharmaceutical industry, Medical imaging, Medical device, Fever, MD, Patient, Safety

DURHAM, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced the presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel (HAV) in the treatment of vascular trauma, as well as results from the treatment of wartime injuries in Ukraine. The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City. Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration (FDA) during the current quarter.

Key Points: 
  • The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City.
  • Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.
  • Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial.
  • Common adverse events reported were anemia, vascular graft thrombosis, blood loss anemia, pyrexia, thrombocytopenia, constipation, nausea peripheral edema, and tachycardia.

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

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星期四, 十一月 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.