Aortic valve

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.”

JenaValve Featured at the PCR London Valves 2023

Retrieved on: 
Wednesday, December 6, 2023
Patient, Mitral regurgitation, Hospital, Aortic stenosis, Prevalence, Aortic regurgitation, Columbia, THV, Aortic valve, Diagnosis, TCT, Surgery

IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from PCR London Valves 2023, a leading, annual global valve conference.

Key Points: 
  • IRVINE, Calif., Dec. 06, 2023 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from PCR London Valves 2023, a leading, annual global valve conference.
  • We have seen cases where the severe MR went away after treating the AR," said Professor Andreas Baumbach, Chair for Device Innovation at Queen Mary University of London.
  • "We are still learning a lot about how to best treat AR, but the possibility of Trilogy as a treatment option is encouraging."
  • The 2023 PCR London Valves Course followed the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting in October, during which JenaValve's pivotal ALIGN-AR study results were presented.

Thubrikar Aortic Valve Announces Authorization to Expand the TAVI-1 CE Mark Trial with the Precision 2™ Delivery Catheter

Retrieved on: 
Friday, December 15, 2023
Other Health, Other Philanthropy, Other Science, Pharmaceutical, Research, Venture Capital, Medical Devices, Fund Raising, Hospitals, Professional Services, Foundation, Philanthropy, Science, Clinical Trials, Cardiology, General Health, Biotechnology, Surgery, Health, NYU Langone Health, DRS, Pressure, Structural heart disease, Mortality, TAV, Patient, University Medical Center, Aortic valve, KCCQ, Stroke, TAVI, Competence, Freedom, Hospital, Mathematical optimization, Medical device, Bara Kodali

Thubrikar Aortic Valve, Inc. today announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™).

Key Points: 
  • Thubrikar Aortic Valve, Inc. today announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™).
  • The authorization allows for an additional 15 patients to be treated with the Optimum TAV™ using the Company’s 2nd-generation delivery catheter, the Precision 2™ Catheter.
  • It allows the Optimum TAV to be repositioned and recaptured for retrieval, if necessary, during the TAVI procedure.
  • Due to the innovative catheter design, the Optimum TAV’s short frame reorients as it is deployed in the diseased valve which results in automatic axial alignment of the valve.

Laguna Tech USA Announces Newly Designed Heart Valves with Advanced Engineering Successfully Implanted in First-in-Human Clinical Trial

Retrieved on: 
Tuesday, October 24, 2023
University, Patient, Trial of the century, Interventional cardiology, Heart, Aortic valve, Instituto Nacional General José Miguel Carrera, ALPHA, Tricuspid valve, Engineering, Aortic regurgitation, ZETA, TAVI, Medical imaging, Medical device

New heart valves, ALPHA and ZETA, designed to provide flexibility and optionality regardless of high, low or zero calcification status

Key Points: 
  • New heart valves, ALPHA and ZETA, designed to provide flexibility and optionality regardless of high, low or zero calcification status
    Patients with aortic regurgitation achieve complete resolution of regurgitation immediately following procedure.
  • To date, two patients have been successfully treated in the Alpha Aortic Valve study, with both achieving complete resolution of aortic regurgitation immediately following the procedure, which has been maintained at the 30-day follow-up examination.
  • The ZETA system is a novel balloon-expandable transcatheter valve with six expanding arms and a low profile covered delivery system.
  • The feasibility study is being conducted at the Instituto Nacional de Torax in Santiago, Chile, and Tbilisi Heart and Vascular Clinic in Georgia.

Artivion Announces Presentation of Real World Data from Post Market Study of On-X® Aortic Heart Valve Replacement Patients Treated with Low Dose Warfarin

Retrieved on: 
Thursday, October 5, 2023
Annual general meeting, European Association for Cardio-Thoracic Surgery, NYSE, INR, Real, EACTS, Thrombosis, Warfarin, Patient, LOR, Aortic valve, Medical imaging

ATLANTA, Oct. 5, 2023 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced data from its On-X Aortic Heart Valve Low INR post-market study presented in a Late-Breaking Science session at the 37th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna, Austria. Real world interim results for all patients confirm that the On-X Aortic Valve remains safe and effective with low-dose warfarin.

Key Points: 
  • Real world interim results for all patients confirm that the On-X Aortic Valve remains safe and effective with low-dose warfarin.
  • Professor Aung Oo, Clinical Lead for Aortovascular Surgery at Barts Heart Centre, London, England, presented an abstract titled, Real World Experience of 510 On-X Aortic Valve Replacement Patients Treated with Low Dose Warfarin.
  • The abstract included at least 1-year and up to 5 years of clinical data on study participants, with median follow up time of 3.4 years.
  • Notably, the data reflected an improvement in outcomes compared to the On-X Aortic Low INR IDE Study (IDE Study) data first published in 2014.

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System

Retrieved on: 
Tuesday, August 1, 2023
Heart, Communication, Heart failure, Extracorporeal, Chest pain, Genesis, Patient, Aortic valve, Aortic regurgitation, Diagnosis, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, AR, Medtech, Food, Fatigue, Disease, Medical device

BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
  • J-Valve™ TF System consists of two key components including the J-Valve™ TF Bioprosthesis and the J-Valve™ TF Delivery Device.
  • The J-Valve™ TF System being granted a Breakthrough Device designation underscores the significance of this innovative development for cardiovascular patients.
  • Warren Wang, Chairman & CEO of Genesis MedTech Group shared, "We believe the Breakthrough Device designation for the J-Valve™ TF System is a testament to the innovative spirit and dedication of our team at Genesis MedTech.

Anteris Technologies Announces First Successful Implantation of DurAVR™ THV in a Valve-in-Valve Procedure

Retrieved on: 
Monday, July 31, 2023
Science, Cardiology, Biotechnology, Research, Surgery, General Health, Health, Medical Devices, Male, Structural heart disease, THV, Singapore Space and Technology Ltd, Calcification, SAVR, Viv, ASX, Multimedia, SAP, Aortic stenosis, Patient, Risk, Aortic valve, Health Canada, Medical imaging, Medical device

These patients are at high risk for another surgery and require a minimally invasive treatment option.

Key Points: 
  • These patients are at high risk for another surgery and require a minimally invasive treatment option.
  • Dr. Asgar performed the procedure on an 84-year-old male and implanted a DurAVR™ THV inside the failed surgical aortic valve replacement (SAVR).
  • Additionally, despite this being an incredibly complex case, using Anteris’ ComASUR™ delivery system and deploying the valve was remarkably easy.
  • Eliminating that compromise would be widely beneficial to a rapidly growing population of patients whose current valve is failing.”

Biological Tissue Valve Segment Surges in the Global Transcatheter Heart Valve Market, Projected to Witness Rapid Growth by 2030

Retrieved on: 
Friday, July 28, 2023
Prevalence, Health, Ageing, Research, TAVI, Aortic stenosis, Percutaneous aortic valve replacement, Patient, Physician, Risk, Tissue engineering, Aortic valve, TAVR, Growth, Abdominal ultrasonography, Valvular heart disease, Medical device, Medical imaging

Aortic stenosis, a condition characterized by the incomplete opening of the aortic valve, has driven the need for transcatheter aortic valve implantation.

Key Points: 
  • Aortic stenosis, a condition characterized by the incomplete opening of the aortic valve, has driven the need for transcatheter aortic valve implantation.
  • Transcatheter Aortic Valve Replacement (TAVR) has emerged as the leading procedure in the global medical market, capturing the highest market share.
  • Rapid Growth of Biological Tissue Market Segment:
    Within the Transcatheter Aortic Valve Replacement (TAVR) industry, the biological tissue market is experiencing rapid growth and emerging as the fastest-growing segment.
  • In conclusion, the global transcatheter heart valve market is set for significant growth, reaching an estimated value of US$ 15.14 Billion by 2030.

Global Transcatheter Heart Valve Market Set to Reach $15.14 Billion by 2030 with a Strong CAGR of 12.73% - ResearchAndMarkets.com

Retrieved on: 
Friday, July 28, 2023
Research, Medical Devices, Technology, Hospitals, Health Technology, Science, Surgery, Cardiology, Biotechnology, Other Technology, Other Science, Health, Prevalence, Ageing, TAVI, Aortic stenosis, Percutaneous aortic valve replacement, Patient, Physician, Risk, Tissue engineering, Aortic valve, TAVR, Growth, Abdominal ultrasonography, Valvular heart disease, Medical device, Medical imaging

Aortic stenosis, a condition characterized by the incomplete opening of the aortic valve, has driven the need for transcatheter aortic valve implantation.

Key Points: 
  • Aortic stenosis, a condition characterized by the incomplete opening of the aortic valve, has driven the need for transcatheter aortic valve implantation.
  • The rising prevalence of aortic stenosis, along with improved surgical techniques and growing demand for surgical technologies, is propelling the transcatheter aortic valve replacement (TAVR) market.
  • Transcatheter Aortic Valve Replacement (TAVR) has emerged as the leading procedure in the global medical market, capturing the highest market share.
  • In conclusion, the global transcatheter heart valve market is set for significant growth, reaching an estimated value of US$ 15.14 Billion by 2030.

Valve Medical Announces Successful First-in-Human Implantation of Ultra-low Profile TAVR Valve in Israel

Retrieved on: 
Wednesday, May 31, 2023
Rabin Medical Center, Aortic stenosis, TEL, Percutaneous aortic valve replacement, Patient, Physician, Risk, Aortic valve, TAVR, Workload, FIH, Medical imaging, Dentistry

TEL AVIV, Israel, May 31, 2023 /PRNewswire/ -- Valve Medical, a wholly owned subsidiary of Medinol Ltd. is pleased to announce today the successful First-in-Human (FIH) implantation of their advanced Transcatheter Aortic Valve Replacement (TAVR) system in Israel, introducing a revolutionary advancement in Structural Heart procedures with the world's first modular valve.

Key Points: 
  • TEL AVIV, Israel, May 31, 2023 /PRNewswire/ -- Valve Medical, a wholly owned subsidiary of Medinol Ltd. is pleased to announce today the successful First-in-Human (FIH) implantation of their advanced Transcatheter Aortic Valve Replacement (TAVR) system in Israel, introducing a revolutionary advancement in Structural Heart procedures with the world's first modular valve.
  • The Valve Medical Xemed TAVR device is a transformational technology designed to improve patient outcomes and procedural success.
  • The distinguishing feature of the valve is its modular design, which has an ultra-low profile, enabling the use of a standard 12 Fr sheath.
  • TAVR is a minimally invasive procedure that replaces the damaged aortic valve with a new valve without the need for open-heart surgery.