Heart valves

Peijia Medical Engages Professor Saibal Kar as Exclusive Consultant

Retrieved on: 
Monday, September 6, 2021

Peijia Medical was founded in 2012 and its headquarter is based in Suzhou, Jiangsu Province, China. It was listed on the Hong Kong Stock Exchange in May 2020. With "Devotion to the Heart, Reverence for Life" as its vision, Peijia Medical always puts life and safety in the first place, striving to maintain human life and health from its years of exploration in technology and its innovative persistence. Peijia Medical's strategic layout can be summarized as the "Innovation-oriented, Simultaneous Treatment of Cardiovascular and Cerebrovascular Diseases". It is dedicated to the innovation, R&D and production of high-end medical devices for structural heart disease and cerebrovascular interventions--covering aortic valve, mitral valve, tricuspid valve, surgical accessories, and diseases related to hemorrhage, ischemia and pathways in cerebrovascular intervention. It has built a relatively comprehensive array of product and solution portfolios in the field of structural heart disease and cerebrovascular interventions for use throughout China.

Key Points: 
  • Dr. Kar currently serves as the Director of Structural Heart Disease Interventions and Clinical Research at Los Robles Health System, and Professor of Medicine at the David Geffen School of Medicine at UCLA.
  • He is recognized as the leading physician in developing and implementing minimally-invasive techniques in structural heart disease interventions.
  • Dr. Kar receives research grants from and is a consultant to multinational companies, such as Boston Scientific Corporation, Gore & Associates, and Abbott Vascular.
  • Peijia Medical was founded in 2012 and its headquarter is based in Suzhou,Jiangsu Province,China.

Peijia Medical Engages Professor Saibal Kar as Exclusive Consultant

Retrieved on: 
Monday, September 6, 2021

Peijia Medical was founded in 2012 and its headquarter is based in Suzhou, Jiangsu Province, China. It was listed on the Hong Kong Stock Exchange in May 2020. With "Devotion to the Heart, Reverence for Life" as its vision, Peijia Medical always puts life and safety in the first place, striving to maintain human life and health from its years of exploration in technology and its innovative persistence. Peijia Medical's strategic layout can be summarized as the "Innovation-oriented, Simultaneous Treatment of Cardiovascular and Cerebrovascular Diseases". It is dedicated to the innovation, R&D and production of high-end medical devices for structural heart disease and cerebrovascular interventions--covering aortic valve, mitral valve, tricuspid valve, surgical accessories, and diseases related to hemorrhage, ischemia and pathways in cerebrovascular intervention. It has built a relatively comprehensive array of product and solution portfolios in the field of structural heart disease and cerebrovascular interventions for use throughout China.

Key Points: 
  • Dr. Kar currently serves as the Director of Structural Heart Disease Interventions and Clinical Research at Los Robles Health System, and Professor of Medicine at the David Geffen School of Medicine at UCLA.
  • He is recognized as the leading physician in developing and implementing minimally-invasive techniques in structural heart disease interventions.
  • Dr. Kar receives research grants from and is a consultant to multinational companies, such as Boston Scientific Corporation, Gore & Associates, and Abbott Vascular.
  • Peijia Medical was founded in 2012 and its headquarter is based in Suzhou,Jiangsu Province,China.

Xeltis Initiates First-ever Pivotal Trial of a Synthetic Restorative Pulmonary Heart Valve

Retrieved on: 
Thursday, July 8, 2021

Xeltis , a clinical-stage company with the most advanced polymer-based restorative cardiovascular devices, today announced that it has started the first-ever pivotal trial for a synthetic restorative pulmonary valve.

Key Points: 
  • Xeltis , a clinical-stage company with the most advanced polymer-based restorative cardiovascular devices, today announced that it has started the first-ever pivotal trial for a synthetic restorative pulmonary valve.
  • View the full release here: https://www.businesswire.com/news/home/20210707005966/en/
    Xeltis synthetic restorative pulmonary heart valve evolves into a fully functioning, natural heart valve through colonization by the patients own tissue.
  • (Photo: Business Wire)
    Following implantation, Xeltis synthetic restorative pulmonary heart valves evolve into fully functioning, natural heart valves through colonization by the patients own tissue.
  • Xplore2/Pivotal is an FDA-approved prospective, non-randomized, open label clinical study of Xeltis restorative pulmonary heart valve in patients requiring right ventricular outflow tract (RVOT) reconstruction.

Tioga Medical, A Shifamed Portfolio Company, Closes $30M In Series B Financing

Retrieved on: 
Wednesday, July 7, 2021

CAMPBELL, Calif., July 7, 2021 /PRNewswire/ -- Tioga Medical, Inc. , a Shifamed portfolio company that aims to redefine structural heart valve replacement, announced today the initial closing of its committed $30M Series B financing.

Key Points: 
  • CAMPBELL, Calif., July 7, 2021 /PRNewswire/ -- Tioga Medical, Inc. , a Shifamed portfolio company that aims to redefine structural heart valve replacement, announced today the initial closing of its committed $30M Series B financing.
  • "Current valve replacement approaches are either surgically invasive, anatomically limited or procedurally complex, hindering use despite the significant clinical need.
  • Tioga's proprietary technology aims to address these challenges with a less invasive, more adaptable transcatheter intervention," commented Gautam Kainth, Managing Director at TCP.
  • Tioga Medical, a privately held portfolio company of Shifamed LLC, is focused on providing elegant valve replacement solutions for mitral and tricuspid applications that are procedurally simpler and use a less invasive, transcatheter approach.

Global Transcatheter Pulmonary Valve Repair (TPVR) Market 2021-2025: Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com

Retrieved on: 
Monday, June 28, 2021

The "Global Transcatheter Pulmonary Valve Repair (TPVR) Market: Size & Forecast with Impact Analysis of COVID-19 (2021-2025)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Transcatheter Pulmonary Valve Repair (TPVR) Market: Size & Forecast with Impact Analysis of COVID-19 (2021-2025)" report has been added to ResearchAndMarkets.com's offering.
  • This report provides an in-depth analysis of the global pulmonary valve repair, with detailed analysis of market size and growth.
  • The report presents analysis of the pulmonary valve repair market by value, by application, by volume, by patient count, by penetration and by region.
  • The report further provides detailed regional analysis of the pulmonary valve repair market by value.

FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

Retrieved on: 
Thursday, May 27, 2021

NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.

Key Points: 
  • NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.
  • The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.
  • The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites.
  • * We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology."

FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA™-T Percutaneous Tricuspid Annuloplasty System

Retrieved on: 
Thursday, May 27, 2021

NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.

Key Points: 
  • NEWTOWN, Pa., May 27, 2021 /PRNewswire/ -- Micro Interventional Devices (MID) has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its MIA-T Percutaneous Tricuspid Annuloplasty System.
  • The MIA-T system treats moderate-severe tricuspid regurgitation (TR) via a 12F catheter-based system.
  • The safety and performance of MIA-T has been demonstrated in the STTAR, Study of Transcatheter Tricuspid Annular Repair, conducted at 6 European clinical sites.
  • * We expect that breakthrough device designation will speed the process to commercialization so patients, physicians and the healthcare system can benefit from this technology."

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

Retrieved on: 
Sunday, April 25, 2021

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

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.

Abbott Receives CE Mark Approval for Next-Generation TriClip™ Device, Offering New Innovations for Tricuspid Heart Valve Repair

Retrieved on: 
Thursday, April 8, 2021

ABBOTT PARK, Ill., April 8, 2021 /PRNewswire/ --Abbott (NYSE: ABT) today announced it has received CE Mark for its next-generation TriClip Transcatheter Tricuspid Valve Repair System, the first-of-its-kind minimally invasive tricuspid heart valve repair device available in Europe to treat tricuspid regurgitation (TR).

Key Points: 
  • ABBOTT PARK, Ill., April 8, 2021 /PRNewswire/ --Abbott (NYSE: ABT) today announced it has received CE Mark for its next-generation TriClip Transcatheter Tricuspid Valve Repair System, the first-of-its-kind minimally invasive tricuspid heart valve repair device available in Europe to treat tricuspid regurgitation (TR).
  • The clip-based therapy, known as TriClip G4, is a non-surgical heart valve repair option specifically designed for the treatment of TR, or a leaky tricuspid valve, that allows physicians to tailor repair of the valve to each patient's unique anatomy.
  • When those leaflets do not close properly, blood can flow in the reverse direction known as regurgitation forcing the heart to work harder.
  • "This newest generation device further improves cardiologists' ability to safely and effectively repair the tricuspid valve, which historically has been extremely challenging to treat."