Aortic regurgitation

JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet

Retrieved on: 
Thursday, March 28, 2024
Hemodynamics, Disease, TCT, Bernard Marcus, Aortic stenosis, Aortic regurgitation, Patient, Mortality, IDE, Columbia University, Manuscript, MPH, Safety, TAVR, Trial of the century, Trilogy, THV, FDA, Food, Pharmaceutical industry

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .

Key Points: 
  • IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet .
  • As presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, the ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.
  • The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients.” Said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).

JenaValve’s Trilogy THV System Highlighted at CRT 2024

Retrieved on: 
Tuesday, March 19, 2024
Observational study, CRT, Conference, Herpetology, Disease, Aortic regurgitation, Patient, Aortic stenosis, Treatment, TAVR, Trilogy, THV, Aorta

IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024.

Key Points: 
  • IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced highlights from the Cardiovascular Research Technologies (CRT) Conference 2024.
  • JenaValve’s Trilogy THV system, a TAVR system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR), and symptomatic, severe aortic stenosis (ssAS), was featured in multiple scientific sessions highlighting the significant unmet need for devices to treat ssAR.
  • This session reviewed an observational study examining outcomes of patients with ssAR treated with off-label THV’s versus a device designed to treat ssAR.
  • Results showed significantly better technical and device success in the Trilogy arm, with significantly less valve embolization, need for a second valve, and post-procedural aortic regurgitation.

egnite, Inc. and JenaValve Announce Novel Research on Outcomes with Untreated Aortic Regurgitation at the 2024 American College of Cardiology Conference

Retrieved on: 
Saturday, April 6, 2024
Research, Technology, Medical Devices, Health Technology, Cardiology, Software, Health, Data Management, Science, Artificial Intelligence, Aortic stenosis, Aortic regurgitation, Patient, Mortality, MD, American College, TAVR, Multimedia, Teaching

egnite, Inc. , a leading digital health company for cardiovascular care, and JenaValve Technology, Inc. , a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, unveil a novel study presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24).

Key Points: 
  • egnite, Inc. , a leading digital health company for cardiovascular care, and JenaValve Technology, Inc. , a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, unveil a novel study presented at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.24).
  • This press release features multimedia.
  • “This research underscores the poor outcomes for patients with moderate AR who exhibit cardiac damage, stressing the need to monitor distinct characteristics in this population.
  • Recent conservative estimates suggest that over 500,000 patients in the United States are diagnosed with moderate or severe AR, indicating a substantial opportunity for novel therapeutic options to treat patients suffering from AR.

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.

JenaValve Announces Partnership with the American Society of Echocardiography (ASE) to Advance Detection and Diagnosis of Aortic Regurgitation

Retrieved on: 
Thursday, November 16, 2023
Aortic regurgitation, IRT, Patient, Cardiovascular disease, American Society of Echocardiography, MD, Diagnosis, Partnership, Echocardiography, THV, Physician, Society, ASE, Health, Education, Medical imaging

Together, JenaValve and ASE will work to drive increased awareness and education of cardiac imaging for the detection and diagnosis of aortic regurgitation (AR).

Key Points: 
  • Together, JenaValve and ASE will work to drive increased awareness and education of cardiac imaging for the detection and diagnosis of aortic regurgitation (AR).
  • “Echocardiography is fundamental to the detection and diagnosis of AR.
  • They bring a unique perspective to echocardiography for heart valve disease,” said Benjamin Eidem, MD, FASE, President of ASE.
  • “This partnership helps both ASE and JenaValve accomplish our shared goal of improving patient care for those suffering from AR.”

Xenter Unveils Groundbreaking Investigational Dual Sensor Wireless GuideWire for Minimally Invasive TAVR Procedures at TCT 2023

Retrieved on: 
Wednesday, November 8, 2023
Cardiology, Data Management, Medical Supplies, Technology, Professional Services, Health, General Health, Venture Capital, Software, Artificial Intelligence, Mobile, Wireless, Aortic regurgitation, Cardiac catheterization, Physician, Para, Data collection, Multimedia, Artificial intelligence, Aortic stenosis, TAVR, Columbia, PVL, Physical, TCT, Collection, AR, Hospital, Medical imaging, Medical device, Medicine

Xenter, Inc. ( Xenter.io ) announced the recent unveiling of its groundbreaking dual sensor investigational guidewire for TAVR procedures at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference in San Francisco, CA.

Key Points: 
  • Xenter, Inc. ( Xenter.io ) announced the recent unveiling of its groundbreaking dual sensor investigational guidewire for TAVR procedures at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 conference in San Francisco, CA.
  • The guidewire is designed to operate seamlessly within a proprietary wireless ecosystem in the Cardiac Catheterization Lab making real-time data and analysis more accessible than ever.
  • Rich Linder, Chairman/CEO of Xenter, founded Xenter to revolutionize the collection of Physical Intelligence™ (PI) data into actionable insights.
  • “We built Xenter to enable Artificial Intelligence (AI) tools to be utilized with ease and accuracy using new smart/wireless medical devices that transmit real-time PI data .

JenaValve Announces Late-Breaking Data from the ALIGN-AR Pivotal Trial Meeting Safety and Efficacy Endpoints

Retrieved on: 
Tuesday, October 24, 2023
FDA, Food, Trilogy, EOA, Quality of life, MD, THV, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Herpetology, IDE, Aortic regurgitation, Cardiomegaly, Aortic stenosis, TAVR, Safety, TCT, AR, Patient, Echocardiography, Heart failure, Medical imaging, Pharmaceutical industry, Medical device

The trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.

Key Points: 
  • The trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint.
  • Outcomes were presented by Dr. Vinod Thourani (Piedmont Heart Institute, Atlanta, GA) during the opening Late-Breaking Clinical Trial sessions at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA.
  • “We are encouraged to see the significant LV mass reduction at over 20% and substantial improvement in quality of life in the ALIGN-AR pivotal trial results,” said Torsten P. Vahl, MD, Principal Investigator of the ALIGN-AR trial.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).

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.

JenaValve Announces ALIGN-AR Pivotal Data to be Presented During the Late-Breaking Clinical Trial Sessions at TCT 2023

Retrieved on: 
Tuesday, September 19, 2023
Aortic stenosis, University, Trilogy, THV, CE marking, Booth, TCT, University of Cologne, Patient, TAVR, Aortic regurgitation, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AR, Food, Safety, Pharmaceutical industry

The presentation will take place on Tuesday, October 24th, at 12:06 PM Pacific Time.

Key Points: 
  • The presentation will take place on Tuesday, October 24th, at 12:06 PM Pacific Time.
  • Prior to the data presentation, at 11:00 AM Pacific Time, a procedure using the CE Mark approved Trilogy THV System will be shown via broadcast from the University of Cologne.
  • Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA).
  • For additional information on the ALIGN-AR Trial or JenaValve, visit the JenaValve team at Booth #215 at TCT.