THV

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

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星期四, 三月 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

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星期二, 三月 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.

JenaValve Featured at the PCR London Valves 2023

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星期三, 十二月 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

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星期四, 十一月 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.”

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

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星期二, 十月 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).

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

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星期二, 九月 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.

DurAVR™ THV Demonstrates Exceptional Results in Second Valve-in-Valve Case

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星期一, 八月 14, 2023
Surgery, Medical Devices, Health, Clinical Trials, Cardiology, AVR, Pressure, Partnership, Failure, THV, Singapore Space and Technology Ltd, Calcification, Clinical trial, Viv, ASX, Multimedia, Vancouver General Hospital, SAP, USD, Aortic stenosis, Patient, Physician, Risk, OTC, TAVR, EFS, Hospital, Health Canada, Valve, Female, Medical device, Medical imaging, Pharmaceutical industry

DurAVR™ THV was implanted in a 79-year-old female who was previously implanted with a Trifecta surgical valve that had severely degenerated, causing debilitating symptoms.

Key Points: 
  • DurAVR™ THV was implanted in a 79-year-old female who was previously implanted with a Trifecta surgical valve that had severely degenerated, causing debilitating symptoms.
  • The intraoperative results after DurAVR™ THV was implanted were phenomenal, with a mean pressure gradient of 7mmHg, restoring near-normal physiology.
  • Today’s case demonstrated what we saw in preclinical testing, that DurAVR™ THV has the potential to offer superior gradients for ViV patients.
  • These outstanding results are not only best in class but deliver options for patients that were previously not seen with existing products.

Anteris Technologies Commences US Early Feasibility Study

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星期三, 八月 9, 2023
Medical Devices, Health, FDA, Surgery, Clinical Trials, Cardiology, AVR, Montefiore Hospital, CMS, Houston Methodist Hospital, THV, MeasureNet Technology Ltd., Interventional cardiology, ASX, Multimedia, TCT, Aortic stenosis, Montefiore, Patient, Montefiore Medical Center, Physician, OTC, EFS, EOA, Research, Safety, Medical device, Medical imaging, Study

Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ Transcatheter Heart Valve (THV), a new class of biomimetic valve and the world’s only biomimetic, single-piece transcatheter aortic valve, was used to successfully to treat patients as part of the DurAVR™ THV Early Feasibility Study (EFS or the Study) in the United States.

Key Points: 
  • Anteris Technologies Ltd, (Anteris or the Company) (ASX: AVR, OTC: ANTTY) reported today that DurAVR™ Transcatheter Heart Valve (THV), a new class of biomimetic valve and the world’s only biomimetic, single-piece transcatheter aortic valve, was used to successfully to treat patients as part of the DurAVR™ THV Early Feasibility Study (EFS or the Study) in the United States.
  • View the full release here: https://www.businesswire.com/news/home/20230809858863/en/
    Dr Azeem Latib and his team from Montefiore Health System with Anteris Technologies employees.
  • Dr. Mike Reardon, Chair of Cardiovascular Research at the Houston Methodist DeBakey Hospital, is the Study Chair.
  • The primary endpoint of this Study at 30 days post-implantation will assess safety and device feasibility.

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

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星期一, 七月 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.”

Proactive news headlines including Dynamic Metals, Ioneer Ltd, Cyprium Metals and Tietto Minerals

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星期一, 一月 16, 2023
Lithium, IND, NAL, INR, Sempra Metals Ltd v IRC, Copper, KZIA, SureFire, DYM, ENR, PBL, PXS, Metal, Aortic stenosis, NVA, ASX, AVR, FIH, Piedmont Lithium, OTCQB, BRU, XETRA, DOE, Kata Tjuta, PLL, LIN, SYA, ADN, Nickel, REE, CTN, DUN, THV, Beryl, DFS, OTC, VRC, MGT, MIN, Safety, IPO, Vanadium, Proactivity, Patient, ILA, Gold, Rare-earth element, Security (finance), Mining, Pharmaceutical industry

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