Aortic valve replacement

NeoChord Announces Successful Completion of First in Human Procedure with its NeoChord NeXuS Transcatheter Mitral Chordal Repair Technology

Retrieved on: 
Monday, October 4, 2021
Â, Achievement, Adrenal insufficiency, Textbook, Mitral valve, Hospital, Patient, Physician, Mitral insufficiency, MD, Heart, Aortic valve replacement, Teaching hospital, Disease, MR, Cardiovascular disease, GLOBE, Medical imaging, Medical device

ST. LOUIS PARK, Minn., Oct. 04, 2021 (GLOBE NEWSWIRE) -- NeoChord, Inc. , a privately-held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation, today announced successful completion of the first-in-human procedure with the NeoChord NeXuS Transcatheter Mitral Chordal Repair technology (TMVr).

Key Points: 
  • ST. LOUIS PARK, Minn., Oct. 04, 2021 (GLOBE NEWSWIRE) -- NeoChord, Inc. , a privately-held medical technology company leading the advancement of beating heart mitral valve repair in patients suffering from mitral valve regurgitation, today announced successful completion of the first-in-human procedure with the NeoChord NeXuS Transcatheter Mitral Chordal Repair technology (TMVr).
  • We are pleased with the positive result of this first-in-human procedure of the NeoChord NeXuS Transcatheter Mitral Chordal Repair device.
  • The NeoChord NeXuS Transcatheter Mitral Chordal Repair device is unique from other mitral valve repair technologies in maintaining a natural physiologic functionality of the mitral valve.
  • NeoChord is now adding the minimally invasive transcatheter chordal repair system NeoChord NeXuS to its portfolio and is underlining the leading position in degenerative mitral valve chordal treatment.

Establishing TAVR for the Treatment of Aortic Regurgitation(1)

Retrieved on: 
Tuesday, June 15, 2021
Anatomy, Medical specialties, Circulatory system, Cardiac surgery, Valvular heart disease, Cardiology, Aortic valve, Percutaneous aortic valve replacement, Aortic insufficiency, Regurgitation, Heart valve, Aortic valve replacement

This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).

Key Points: 
  • This milestone includes patients enrolled in the multi-center prospective clinical trial, treating symptomatic, severe high surgical risk aortic regurgitation (AR) patients (The ALIGN-AR Clinical Trial).
  • AR is a condition that occurs when a patients aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle.
  • The current treatment for high surgical risk patients who are not candidates for open-heart surgery is limited and consists of medical management.
  • JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K., and Munich, Germany, develops and manufactures transcatheter aortic valve implantation (TAVR) systems to treat patients suffering from aortic valve disease.

Abbott Receives CE Mark for Navitor™, the Latest-Generation Transcatheter Aortic Valve Implantation (TAVI) System to Treat Aortic Stenosis

Retrieved on: 
Monday, May 17, 2021
Medical specialties, Cardiac surgery, Clinical medicine, Medicine, Percutaneous aortic valve replacement, Aortic valve replacement, Aortic valve, Aortic stenosis, Valve replacement, Heart valve, Edwards Lifesciences, Aortic valve repair

b'ABBOTT PARK, Ill., May 17, 2021 /PRNewswire/ -- Abbott (NYSE: ABT)today announced it has received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, making the minimally invasive device available for people in Europe with severe aortic stenosis who are at high or extreme surgical risk.

Key Points: 
  • b'ABBOTT PARK, Ill., May 17, 2021 /PRNewswire/ -- Abbott (NYSE: ABT)today announced it has received CE Mark for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, making the minimally invasive device available for people in Europe with severe aortic stenosis who are at high or extreme surgical risk.
  • With the Navitor valve, the company is advancing TAVI (also referred to as TAVR, or transcatheter aortic valve replacement) therapies with innovations including a unique design to prevent blood leaking around the valve.
  • "This approval strengthens our structural heart portfolio of minimally invasive offerings by providing new options and improvements to treat a life-threatening heart condition.
  • Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk.

New Survey Identifies Opportunity to Improve Shared Decision Making Between Cardiologists and Heart Valve Disease Patients

Retrieved on: 
Friday, May 14, 2021
Cardiac surgery, Medical specialties, Clinical medicine, Medicine, Aortic valve replacement, Aortic valve, Percutaneous aortic valve replacement, Aortic stenosis, Valve replacement, Valvular heart disease, Aortic valve repair, Mitral valve replacement

Currently, treatment options for AS include transcatheter aortic valve replacement (TAVR), a minimally invasive procedure, or a surgical aortic valve replacement (SAVR), also known as open heart surgery.

Key Points: 
  • Currently, treatment options for AS include transcatheter aortic valve replacement (TAVR), a minimally invasive procedure, or a surgical aortic valve replacement (SAVR), also known as open heart surgery.
  • However, more than half of cardiologists surveyed (53%) feel that their symptomatic severe AS patients are not as informed as they should be about their treatment options.\nThe findings indicate physicians recognize the importance of shared decision making to achieve individualized care for heart valve disease patients.
  • More than 3,400 responses were received from heart valve patients and caregivers.
  • Of the respondents, 94% identified as heart valve patients, 53% identified as aortic stenosis patients.\n'

Peijia Medical's TaurusOne® Transcatheter Aortic Valve Replacement System Approved for Commercialization

Retrieved on: 
Sunday, April 25, 2021
Anatomy, Heart, Cardiac surgery, Heart valves, Aortic valve, Bicuspid aortic valve, Heart valve, Aorta, Aortic valve replacement, Pericardial heart valves

The clinical trial protocol employed strict enrollment criteria and passed the pre-clinical review and got approved by the CFDA (now NMPA).

Key Points: 
  • The clinical trial protocol employed strict enrollment criteria and passed the pre-clinical review and got approved by the CFDA (now NMPA).
  • "\nTaurusOne consists of a prosthetic aortic valve, a delivery catheter and a compression loading system.
  • The aortic valve leaflet is made of bovine pericardium and is processed with a proprietary anti-calcification technique.
  • The stent\'s inflow end has an enhanced radial force design, given that China has a large proportion of patients with high aortic valve calcification or bicuspid aortic valves.

Peijia Medical's TaurusOne® Transcatheter Aortic Valve Replacement System Approved for Commercialization

Retrieved on: 
Sunday, April 25, 2021
Anatomy, Heart, Cardiac surgery, Heart valves, Aortic valve, Bicuspid aortic valve, Heart valve, Aorta, Aortic valve replacement, Pericardial heart valves

The clinical trial protocol employed strict enrollment criteria and passed the pre-clinical review and got approved by the CFDA (now NMPA).

Key Points: 
  • The clinical trial protocol employed strict enrollment criteria and passed the pre-clinical review and got approved by the CFDA (now NMPA).
  • "\nTaurusOne consists of a prosthetic aortic valve, a delivery catheter and a compression loading system.
  • The aortic valve leaflet is made of bovine pericardium and is processed with a proprietary anti-calcification technique.
  • The stent\'s inflow end has an enhanced radial force design, given that China has a large proportion of patients with high aortic valve calcification or bicuspid aortic valves.

BioStable Science & Engineering Announces CE Mark Approval for the HAART 200 Aortic Annuloplasty Device & Surpasses 1,000 Patients Treated Worldwide with the HAART Devices

Retrieved on: 
Wednesday, April 21, 2021
Biotechnology, Surgery, Medical devices, Health, Cardiology, Cardiac surgery, Medical specialties, Clinical medicine, Medicine, Aortic valve repair, Aortic valve replacement, Bicuspid aortic valve, Aortic valve, Aortic insufficiency, Mitral valve annuloplasty, BAV, Valve replacement

b'BioStable Science & Engineering, Inc. (\xe2\x80\x9cBioStable\xe2\x80\x9d) announced today the company has received CE Mark approval for the HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve repair.

Key Points: 
  • b'BioStable Science & Engineering, Inc. (\xe2\x80\x9cBioStable\xe2\x80\x9d) announced today the company has received CE Mark approval for the HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve repair.
  • With CE Mark approval of both the HAART 300 and HAART 200 Aortic Annuloplasty Devices, BioStable will be able to offer surgeons within the European Union a comprehensive portfolio of aortic valve repair solutions that address all forms of aortic valve insufficiency.
  • Approximately 53% of BAV patients require aortic valve surgery within 25 years of being diagnosed [1].
  • Most BAV patients undergo aortic valve replacement between 40 and 60 years of age, subjecting them to increased risk of reoperation or complications associated with valve replacement technologies [2].

JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

Retrieved on: 
Thursday, March 18, 2021
Cardiac surgery, Medicine, Medical specialties, Anatomy, Aortic valve replacement, Aortic valve, Percutaneous aortic valve replacement, Regulatory affairs, Valve replacement, Heart valve

IRVINE, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf to Vice President, Regulatory Affairs and Quality, effective immediately.

Key Points: 
  • IRVINE, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf to Vice President, Regulatory Affairs and Quality, effective immediately.
  • Ms. Metcalf comes to JenaValve with over 30 years of experience in the medical device industry providing leadership in areas of regulatory affairs, clinical and quality assurance.
  • Jane has a strong track record of successfully developing strategies for worldwide regulatory approvals of innovative devices, said JenaValve CEO John Kilcoyne.
  • Prior to joining JenaValve, Ms. Metcalf served as Vice President of Regulatory Affairs and Quality Assurance at Sonendo Medical.

Progress being made but more needed for heart valve disease patients in Canada

Retrieved on: 
Monday, February 22, 2021
Medical specialties, Clinical medicine, Medicine, Cardiac surgery, Aortic valve, Percutaneous aortic valve replacement, Aortic stenosis, Heart valve, Bicuspid aortic valve, Valvular heart disease, Aortic valve replacement, Hybrid cardiac surgery

HVV Canada is calling on all provincial governments to prioritize heart valve disease care to ensure timely access to treatment.

Key Points: 
  • HVV Canada is calling on all provincial governments to prioritize heart valve disease care to ensure timely access to treatment.
  • Health Canada recently expanded the eligibility of low-risk patients for a minimally invasive procedure called Transcatheter Aortic Valve Implantation (TAVI) to treat severe aortic stenosis and bicuspid aortic valve disease.
  • This is an essential consideration if we are to continue bettering access to appropriate treatments for heart valve disease patients.
  • Heart Valve Voice Canada is a non-profit patient advocacy organization that works to improve the health and quality of life of people living with heart valve disease.

Foldax Biopolymer Shown to Possess Ideal Properties for Heart Valve in New Published Paper

Retrieved on: 
Tuesday, January 26, 2021
Health, Chemicals, Plastics, Medical devices, Manufacturing, Other Manufacturing, Cardiology, Biotechnology, Medical specialties, Cardiac surgery, Clinical medicine, Medicine, Aortic valve replacement, Aortic valve, Percutaneous aortic valve replacement, Valve replacement, Heart valve

Together with the earlier reported work on this new SiPUU copolymer, an exhaustive data set now confirms LifePolymers suitability for use as a leaflet in a replacement heart valve.

Key Points: 
  • Together with the earlier reported work on this new SiPUU copolymer, an exhaustive data set now confirms LifePolymers suitability for use as a leaflet in a replacement heart valve.
  • The third valve product is a transcatheter aortic valve replacement (TAVR), which is in the pre-clinical testing phase.
  • The Tria valves are the first and only heart valves to be robotically manufactured, reducing variability and enabling high precision, repeatability and quality, while substantially improving the economics of heart valve manufacturing.
  • Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures.