Percutaneous aortic valve replacement

Medtronic Announces CE Mark of Evolut™ PRO+ TAVI System for Treatment of Symptomatic Severe Aortic Stenosis Patients in Europe

Retrieved on: 
Monday, May 3, 2021
Percutaneous aortic valve replacement, Medtronic, Tavi, MDT, Medicine, Health care

b'As TAVI Patient Population Grows, PRO+ TAVI System Launches with Four Valve Sizes and Lowest Delivery Profile\nDUBLIN, May 3, 2021 /PRNewswire/ --Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced CE (Conformit Europenne) Mark of the Evolut PRO+ TAVI System the newest-generation Medtronic TAVI system that builds off the proven self-expanding, supra-annular Evolut TAVI platform.

Key Points: 
  • b'As TAVI Patient Population Grows, PRO+ TAVI System Launches with Four Valve Sizes and Lowest Delivery Profile\nDUBLIN, May 3, 2021 /PRNewswire/ --Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced CE (Conformit Europenne) Mark of the Evolut PRO+ TAVI System the newest-generation Medtronic TAVI system that builds off the proven self-expanding, supra-annular Evolut TAVI platform.
  • The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market.
  • Because of its design and long track record of exceptional clinical outcomes, the Evolut TAVI platform is well-suited to meet these needs.
  • The additional pericardial wrap in the 34 mm Evolut PRO+ may also reduce the degree of residual perivalvular regurgitation.

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.

Protembis Announces Completion of 20 Cases in European CE Mark Study With the ProtEmbo® Cerebral Protection System

Retrieved on: 
Thursday, February 25, 2021
Cardiology, Biotechnology, Professional services, Health, Pharmaceutical, Venture capital, Medical devices, Research, Surgery, Science, Clinical trials, Medical specialties, Medicine, Clinical medicine, Cardiac surgery, Percutaneous aortic valve replacement, Aortic valve, Valve replacement

Protembis GmbH , a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo Cerebral Protection System.

Key Points: 
  • Protembis GmbH , a privately held emerging medical device company, announced today the successful completion of 20 clinical cases in its European regulatory study of the ProtEmbo Cerebral Protection System.
  • The ProtEmbo System is an intra-aortic filter device that deflects embolic material away from the brain during transcatheter aortic valve replacement (TAVR).
  • The objective of the European trial (PROTEMBO C Trial, NCT04618718 ) is to assess the safety and performance of the ProtEmbo System used for embolic protection during TAVR compared to historical data.
  • Protembis is a privately-held, emerging medical device company that has developed the ProtEmbo Cerebral Protection System.

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.

Insights on the Transcatheter Treatment: Procedures and Heart Valve Global Market to 2025 - Key Drivers and Restraints

Retrieved on: 
Friday, February 12, 2021
Medicine, Clinical medicine, Medical specialties, Cardiac surgery, Percutaneous aortic valve replacement, Valvular heart disease, Mitral valve replacement, Minimally invasive procedure, Cardiology, Edwards Lifesciences, Valve replacement

Europe is the second-largest market after the U.S., and there are many established and early-stage companies that are working to enter the European TAVR market by developing improved transcatheter heart valve devices.

Key Points: 
  • Europe is the second-largest market after the U.S., and there are many established and early-stage companies that are working to enter the European TAVR market by developing improved transcatheter heart valve devices.
  • With regard to the European transcatheter treatment device market, it is growing mainly due to improved healthcare infrastructure, increasing prevalence of heart disease, improving diagnosis rates, and growing demand for minimally invasive and catheter-based treatment options.
  • Additionally, the increased patient population and improving diagnosis rate are likely to increase the demand for TAVR/TAVI and TMVR procedures within the region.
  • Japan is an established market in Asia-Pacific, while China and India are emerging markets that are growing rapidly.

Worldwide Transcatheter Treatment Procedures and Heart Valve Industry to 2025 - Major Developments Influencing the Market - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 11, 2021
Health, Medical devices, Cardiology, Clinical medicine, Medicine, Medical specialties, Cardiac surgery, Percutaneous aortic valve replacement, Valvular heart disease, Mitral valve replacement, Cardiology, John G. Webb, Edwards Lifesciences

The "Transcatheter Treatment: Procedures and Heart Valve Market" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Transcatheter Treatment: Procedures and Heart Valve Market" report has been added to ResearchAndMarkets.com's offering.
  • Transcatheter treatment includes procedure types such as TAVR, TAVI, TMVR and TMVI.
  • Transcatheter procedure approaches include transfemoral, transapical and transaortic procedures.
  • This report is an analytical business tool with the primary purpose of providing a thorough evaluation of the global market for transcatheter treatment for heart valve diseases.

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.

Alleviant Medical Receives Breakthrough Device Designation From FDA for Transcatheter Technology

Retrieved on: 
Monday, January 25, 2021
Medical devices, Surgery, Venture capital, FDA, Professional services, Cardiology, Other Health, Biotechnology, General Health, Health, Medical technology, Prosthetics, Medicine, Biomedical engineering, Implant, Tissue engineering, Medical device, Biotechnology, Edwards Lifesciences, Percutaneous aortic valve replacement

Alleviant Medical Inc. , a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology.

Key Points: 
  • Alleviant Medical Inc. , a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology.
  • By utilizing a no-implant interatrial shunt approach, the Alleviant Medical technology offers the option for a simple, minimally-invasive procedure for heart failure patients.
  • We appreciate the rigorous review by the FDA and their designation of our technology as a Breakthrough Device.
  • Alleviant Medical is a privately held medical device company that is dedicated to developing novel therapies for patients suffering from heart failure.

Transcatheter Heart Valve Replacement Market Revenue to Cross USD 19.5 Bn by 2026: Global Market Insights, Inc.

Retrieved on: 
Tuesday, January 19, 2021
Cardiac surgery, Medical specialties, Clinical medicine, Medicine, Aortic valve replacement, Percutaneous aortic valve replacement, Heart valve, Aortic valve, Mitral valve replacement, Mitral valve, Valvular heart disease, Valve replacement

SELBYVILLE, Del., Jan. 18, 2021 /PRNewswire/ --According to the latest report "Transcatheter Heart Valve Replacement Market by Product (Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve Repair and Replacement, Transcatheter Pulmonary Valve Replacement), Surgical Approach (Transfemoral Approach, Transapical Approach), Application (Aortic Valvular Heart Disease, Mitral Valvular Heart Disease, Pulmonary Valvular Heart Disease), End-use (Hospitals, Cath Labs), Regional Outlook, Price Trends, Competitive Market Share & Forecast 2026", by Global Market Insights, Inc., the market valuation of transcatheter heart valve replacement will cross $19.5 billion by 2026.

Key Points: 
  • SELBYVILLE, Del., Jan. 18, 2021 /PRNewswire/ --According to the latest report "Transcatheter Heart Valve Replacement Market by Product (Transcatheter Aortic Valve Replacement, Transcatheter Mitral Valve Repair and Replacement, Transcatheter Pulmonary Valve Replacement), Surgical Approach (Transfemoral Approach, Transapical Approach), Application (Aortic Valvular Heart Disease, Mitral Valvular Heart Disease, Pulmonary Valvular Heart Disease), End-use (Hospitals, Cath Labs), Regional Outlook, Price Trends, Competitive Market Share & Forecast 2026", by Global Market Insights, Inc., the market valuation of transcatheter heart valve replacement will cross $19.5 billion by 2026.
  • Rising interest of manufacturers in emerging countries such as the Middle East and Africa will drive the transcatheter heart valve replacement market expansion.
  • Transapical approach segment in the transcatheter heart valve replacement market exceeded USD 1.16 billion in 2019.
  • Transcatheter mitral valve replacement devices are undergoing feasibility trials that will further propel the number of patients undergoing transcatheter mitral valve replacement.

Medtronic Evolut™ TAVI Now Licensed for Both Bicuspid Aortic Valves at Intermediate or Greater Risk and for Low Risk of Surgical Mortality

Retrieved on: 
Monday, January 11, 2021
Medical specialties, Circulatory system, Clinical medicine, Cardiac surgery, Valvular heart disease, Aortic valve, Percutaneous aortic valve replacement, Aortic stenosis, Cardiology, Bicuspid aortic valve, Heart valve, Aortic valve replacement

Medtronic's TAVI platform is currently the only system licensed for both bicuspid aortic valves (intermediate or greater risk), as well as all surgical risk categories in Canada.

Key Points: 
  • Medtronic's TAVI platform is currently the only system licensed for both bicuspid aortic valves (intermediate or greater risk), as well as all surgical risk categories in Canada.
  • Evolut is now indicated in Canada for severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low).
  • The expanded indication also allows patients with bicuspid aortic valves at extreme, high and intermediate risk of surgical mortality to also receive the procedure.
  • DOI:10.1056/NEJMoa1816885
    Reardon, Michael J. Evolut Surgical Replacement and Transcatheter Aortic Valve Implantation in Low Risk Patients - Evolut Low Risk.