TMVR

OrbusNeich's Joint Venture Kicks Off TricValve Clinical Trial in Mainland China

Retrieved on: 
Wednesday, April 24, 2024
Tricuspid valve, FDA, TMVR, Hope, Hospital, Percutaneous coronary intervention, NMPA, Safety, Valvular heart disease, OrbusNeich, PCI, TAVR, Patient, PTA, Zhongshan Hospital, Fudan University, Cardiology, Aortic stenosis, Clinical trial, Quality of life, Medical device

The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.

Key Points: 
  • The CE-marked medical device was named a Breakthrough Device and an Innovative Medical Device by the FDA in the United States and NMPA in China, respectively.
  • It has effectively treated a 56-year-old patient with severe tricuspid regurgitation, marking the commencement of the clinical trial across Mainland China.
  • Led by principal investigator Prof. Ge Junbo, Academician Zhongshan Hospital, Fudan University, and his team, the clinical trial aims to assess the safety and efficacy of TricValve.
  • Mr. Peter Peh, General Manager of OrbusNeich P&F, said, "We are pleased to see TricValve moving into clinical trial, marking the first successful implantation of a percutaneous transcatheter bicaval device in a patient by cardiologists in Mainland China, to address severe tricuspid valve regurgitation.

4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies

Retrieved on: 
Wednesday, May 8, 2024
FDA, TMVR, Mitral valve, Risk, Food, Death, Health technology, Interbalkan Medical Center, Patient, Pivotal, Medicine, Heart failure, Medical device

MINNEAPOLIS, May 8, 2024 /PRNewswire/ -- 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for the AltaValve™ System, a transcatheter mitral valve replacement (TMVR) device.

Key Points: 
  • MINNEAPOLIS, May 8, 2024 /PRNewswire/ -- 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for the AltaValve™ System, a transcatheter mitral valve replacement (TMVR) device.
  • Among other benefits, Breakthrough Device designation expedites the review process, shortening the time until technology reaches patients if approved by the FDA.
  • Specifically, the FDA granted the AltaValve System Breakthrough Device designations for two therapeutic indications:
    MR occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts.
  • Due to the complexity of the mitral valve anatomy and comorbidities typically present in this patient population, limited medical therapies are available to clinicians and their patients.

Vivasure Medical Announces First Large Hole Venous Patient Treated with PerQseal Elite Vascular Closure System

Retrieved on: 
Monday, April 15, 2024
Biotechnology, Surgery, Medical Devices, Health, Cardiology, Collagen, Interventional cardiology, TMVR, Safety, Patient, Medicine, Suture, Elite, Medical imaging

Vivasure Medical ®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has treated the first large bore venous patient with the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device.

Key Points: 
  • Vivasure Medical ®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has treated the first large bore venous patient with the PerQseal® Elite vascular closure system, a sutureless and fully bioresorbable large-bore vessel closure device.
  • Leveraging Vivasure Medical’s PerQseal technology, the PerQseal Elite vascular closure system is designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants.
  • “Current venous closure methods are not indicated for large hole venous access applications like Transcatheter Edge-to-Edge repair (TEER), TMVR and TTVR.
  • “We’re encouraged by the early progress we’ve seen in clinical studies of the Elite vascular closure system to address this unmet need.

Tampa General Hospital Is the First and Only in the Southeast to Complete Transcatheter Mitral Valve Replacement (TMVR) with AltaValve Technology

Retrieved on: 
Tuesday, January 30, 2024
Surgeon, Standard of care, Research, Division, TAVR, Mitral regurgitation, 3D, Nursing, Patient, Tampa General Hospital, Faculty, FDA, Food, TGH, Health, Physician, Hope, Heart failure, Tricuspid valve, TMVR, Bezerra

TAMPA, Fla., Jan. 30, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter. The patient suffered from severe mitral regurgitation (MR), a common heart disease that generally requires open heart surgery. The patient underwent the minimally invasive procedure in December at Tampa General's main campus on Davis Islands in downtown Tampa and was safely discharged after just two days.

Key Points: 
  • TAMPA, Fla., Jan. 30, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter.
  • "At Tampa General, we're pioneering new technologies that can save lives, especially for the patients with the highest risk," said John Couris, president and CEO of Tampa General Hospital.
  • "The transcatheter mitral valve replacement was made possible by a multidisciplinary team of best-in-class professionals who don't just meet standards of care; they establish them.
  • In preliminary clinical trials of the AltaValve, patients experienced significant improvement in heart function and a reduction in symptoms of mitral valve regurgitation.

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™

Retrieved on: 
Monday, January 22, 2024
Health, FDA, Medical Devices, Health Technology, Other Health, Cardiology, Biotechnology, Patient, Hemodynamics, MD, Percutaneous aortic valve replacement, Aortic stenosis, TMVR, Risk, Food, Morristown Medical Center, Heart, TAVR, Diagnosis, Medical device

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.

Key Points: 
  • Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.
  • This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023.
  • “Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut™,” said Philippe Genereux, MD from Morristown Medical Center in New Jersey.
  • “Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut™ to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve.

Pi-Cardia Hires Gary Gratson to Lead Global Commercialization

Retrieved on: 
Monday, December 11, 2023
Cardiology, Biotechnology, Other Communications, Health, Marketing, Medical Devices, Communications, Other Health, TAVR, Heart, TMVR, Risk, Percutaneous aortic valve replacement, Patient, Multimedia, Hemodynamics, Aortic stenosis, Growth, Physician, Medical device

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction.

Key Points: 
  • Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction.
  • This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023.
  • In his new role, Mr. Gratson will be responsible for building and leading the US commercial organization, driving strategic initiatives, and contributing to the continued growth of Pi-Cardia.
  • "I am honored to join Pi-Cardia at such exciting times,” said Mr. Gratson.

ReValve Solutions Announces Successful First-in-Human with Next Generation TMVR Technology

Retrieved on: 
Wednesday, November 29, 2023
Health, Medical Devices, Surgery, Health Technology, Clinical Trials, Cardiology, Biotechnology, LVOT, East Carolina University, Medical director, Chair, TMVR, Mitral regurgitation, History, Patient, Heart, Northwestern Memorial Hospital, Male, Interventional cardiology, Heart failure, Tricuspid valve, Mitral valve, Retail Solutions Inc., University, Patent, Medical device

ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.

Key Points: 
  • ReValve Solutions Inc. (ReValve), which has developed a next generation technology for Transcatheter Mitral Valve Replacement (TMVR), announced that an 81-year-old male, with a history of heart failure, a series of failed surgical by-pass grafts and severe mitral regurgitation (MR 4+), was successfully treated with the Palmetto System.
  • ReValve’s technology is designed to replace the Mitral Valve while also preserving the heart’s natural basal left ventricular function.
  • Our flexibility and four-point securement system provide a patent LVOT and maintains left ventricular function throughout recovery,” said Julie Logan Sands, Founder and CEO ReValve Solutions.
  • ReValve’s first-of-its-kind TMVR is thoughtfully designed to expand the treatable population of patients suffering from Mitral Valve Disease,” added Sands.

ConcertAI's TeraRecon Showcases New Clinical and AI Solutions Designed to Enhance Treatment Planning for Structural Heart Patients at TCT 2023

Retrieved on: 
Monday, October 23, 2023
Digital twin, Digital, FDA, The Advanced Visualizer, Physician, FACC, CE, Cardiology, PM, Intuition, TMVR, AV, Artificial intelligence, Radiology, LAA, Partnership, Neurology, Workflow, FHRS, TCT, Patient, CT scan, Medical imaging, Medical device, MD

NEW strategic partnership to offer FEops HEARTguide™ Digital Twin solution for an elevated structural heart experience for LAA closure procedures.

Key Points: 
  • NEW strategic partnership to offer FEops HEARTguide™ Digital Twin solution for an elevated structural heart experience for LAA closure procedures.
  • LIVE physician-led presentations on advancing cardiac care utilizing Intuition 4.7, and FEops solutions.
  • Cardiology Suite applications on the Eureka Clinical AI platform are FDA and CE-cleared with additional regional clearances.
  • FEops HEARTguide is a unique cloud-based procedure planning solution in the structural heart, based on Digital Twin technologies.

Pi-Cardia Successfully Completes Enrollment in Pivotal Study for ShortCut™

Retrieved on: 
Wednesday, September 20, 2023
Medical Devices, Health, Surgery, Other Health, Cardiology, Biotechnology, CT, TMVR, Workflow, DRS, Heart, TCT, Aortic stenosis, Percutaneous aortic valve replacement, Patient, Risk, Hemodynamics, TAVR, Growth, Medical device

Pi-Cardia Ltd ., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today the successful completion of its ShortCut™ Pivotal Study enrollment.

Key Points: 
  • Pi-Cardia Ltd ., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today the successful completion of its ShortCut™ Pivotal Study enrollment.
  • The study was conducted across 20 of the world’s leading TAVR centers in the US and Europe and was led by Drs.
  • Susheel Kodali (New York Presbyterian/Columbia University, New York, USA), Didier Tchétché (Clinique Pasteur, Toulouse, France) and Danny Dvir (Sha’are Zedek, Jerusalem, Israel).
  • "We are excited to have been able to complete enrollment in such a groundbreaking study so efficiently,” said Dr. Kodali.

China TAVR & TMV Market Report 2023: Growing Prevalence of Aortic Stents and Rising Approval of New TAVR Products - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 27, 2023
Medical Devices, Health, Venus, Urbanization, TMVR, Prevalence, Policy, TMV, Aortic stenosis, US, Medtronic, MicroPort, Patient, TAVR, Growth, R, Medical device

China's TAVR market is expected to reach US$2.60 billion in 2027, growing at a CAGR of 55.91%, for the duration spanning 2023-2027.

Key Points: 
  • China's TAVR market is expected to reach US$2.60 billion in 2027, growing at a CAGR of 55.91%, for the duration spanning 2023-2027.
  • While, the TMV market in China is forecasted to reach US$1832.05 million in 2027, rising at a CAGR of 146.50%, for the time period of 2023-2027.
  • Factors such as growing prevalence of aortic stenosis, rise in approval of new TAVR products, rise in geriatric population and rapid urbanization would drive the growth of the market.
  • The report provides a comprehensive analysis of the China TAVR and TMV Market.