Mitral valve

HighLife Receives IDE Approval to Initiate US Pivotal Clinical Study for treatment of Mitral Regurgitation

Retrieved on: 
måndag, juni 3, 2024
Highlife, Level 5, IDE, TMVR, Mitral regurgitation, Patient, American College, Mitral valve, Safety, Tricuspid valve, FMR, Journal, Food, Principal, FDA, Life expectancy, Pivotal, Mount Sinai Health System, Pharmaceutical industry

The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment.

Key Points: 
  • The Pivotal Study is a single-arm, multicenter, prospective study assessing the safety and effectiveness of the HighLife TSMVR solution in patients with moderate to severe Functional Mitral Regurgitation (FMR), unsuitable for surgery or transcatheter repair treatment.
  • The pivotal study is expected to enroll patients at clinical sites in the United States, Europe and APAC.
  • Over 100 patients have been treated with the HighLife technology within different clinical programs in the USA, Europe and APAC.
  • There is still a significant unmet clinical need for patients suffering from mitral regurgitation and TMVR is a promising treatment option.

SS Innovations’ SSi Mantra Surgical Robotic System Used to Perform 100 Cardiac Surgeries, Signaling Market Expansion

Retrieved on: 
tisdag, maj 21, 2024
BIMA, Patient, Mitral valve, Elective surgery, Consultant, FDA, Trauma, Mantra, TECAB, Atrial septal defect, Internal, OTC, Internal thoracic artery, Mitral valve replacement, IMA, CE marking, Quality of life, Medical device

FORT LAUDERDALE, Fla., May 21, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that 100 robotic cardiac surgery procedures have been successfully performed with the Company’s SSi Mantra Surgical Robotic System. 

Key Points: 
  • Dr. Sudhir Srivastava, SS Innovation’s Chairman and CEO, commented, “Reaching this milestone with the SSi Mantra is another notch in SS Innovations' strategic market expansion—transforming practices, enhancing access, and driving the widespread use of robotic surgery.
  • The Mantra’s innovative design, featuring a fifth arm capability, uniquely enables it to perform complex cardiac surgeries—a high demand market previously without an effective robotic solution.
  • The successful use of the SSi Mantra in cardiac surgeries is transforming practices and setting the path to boost global adoption of robotic surgery.
  • I believe that most robotic cardiac surgical procedures in the future will be done on the SSI Mantra Surgical Robotic System.”

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

Retrieved on: 
onsdag, maj 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.

The Inner Circle Acknowledges, Divyakant B. Gandhi, MBBS, FRCS, FACS, Circle as a Distinguished Cardiothoracic Surgeon

Retrieved on: 
måndag, maj 6, 2024
Doctor of Philosophy, Education, Atrial fibrillation, Cardiothoracic surgery, American College, Multimedia, Lung cancer, MBBS, Coronary artery disease, Mentorship, Ohio State University, Ventricular septal defect, Elective surgery, Heart, Parent, Research, University, FACS, Multiple, Lung, Inner circle, McLaren Health Care Corporation, Patient, Medicine, Circulatory system, Physician, Intellectual property, Health, Mitral valve, FRCS, Student, General surgery, Quality of life, Georgia Tech, Medical college, Royal, Royal college

Divyakant B. Gandhi is an international physician, innovative thinker, and leader in cardiac care.

Key Points: 
  • Divyakant B. Gandhi is an international physician, innovative thinker, and leader in cardiac care.
  • He has been in practice as a Heart, Lung & Vascular surgeon for over 35 years.
  • As a leader in the clinical setting, Dr. Gandhi is the Chief of Staff, Medical Director, and Chief of Cardiovascular & Thoracic Surgery at McLaren Greater Lansing.
  • Dr. Gandhi practices his specialty under the auspices of the Center for Cardiovascular and Thoracic Surgery in Detroit, MI.

Affluent Medical : 2023 financial results and update on clinical activities under development.

Retrieved on: 
fredag, maj 3, 2024
Medtech, FDA, Risk, De novo, Death, Mitral regurgitation, Doctor of Philosophy, Wound healing, Mitral valve annuloplasty, Boston Scientific, Ticker, Wealth, Urinary incontinence, Woman, Christophe, Food, Neurostimulation, Myocardial infarction, Aix-en-Provence, DSM-IV codes, LCEA, Mitral valve, TAVI, Minerva, Certification, Heart, Quality assurance, System, Anatomy, Exercise, NYHA, Dry, Marketing, Clinical trial, American College, Development director, MD, Endocarditis, Medtronic, Patient, Tricuspid valve, Acquisition, Medical device

Affluent Medical : 2023 financial results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2023 financial results and update on clinical activities under development.
  • Affluent Medical estimates that KaliosTM would avoid repeat surgery for 30-40% of patients within five years of their operation.
  • In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after one year of implantation.
  • In July 2023, Affluent Medical announced the appointments of Christophe de Vregille as Chief Financial Officer and Benjamin Renault as Development Director.

SS Innovations’ SSi Mantra Surgical Robotic System used to perform Mitral Valve Replacement

Retrieved on: 
tisdag, mars 12, 2024
Mitral valve replacement, Exercise, Tricuspid valve, Narayana Health, Patient, Mitral valve, Surgeon, Sternum, OTC, Medical device

FORT LAUDERDALE, Fla., March 12, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that surgeons have successfully performed the world’s first mitral valve replacement using the Made in India, SSi Mantra Surgical Robotic System.

Key Points: 
  • FORT LAUDERDALE, Fla., March 12, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that surgeons have successfully performed the world’s first mitral valve replacement using the Made in India, SSi Mantra Surgical Robotic System.
  • This procedure was carried out at the Narayana Hrudayalaya Institute of Cardiac Sciences in Bengaluru, India, and represents a milestone in the treatment of heart disease using the SSi Mantra Surgical Robotic System.
  • “We are very proud that using our Made in India, SSi Mantra Surgical Robotic System, we have performed a variety of robotic heart surgeries including, Bilateral Internal Mammary Takedowns, Totally Endoscopic Coronary Artery Bypass on a beating heart, Atrial Septal Defect Repair and now a completely robotic Mitral Valve Replacement.
  • The SSi Mantra Surgical Robotic System, the first surgical robotic system to be made in India, and one of the few cost-effective global options with a wide range of surgical applications, has received regulatory approval in India, Indonesia and Guatemala, and is clinically validated for over 50 different types of surgical procedures.

Affluent Medical : Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.

Retrieved on: 
onsdag, mars 13, 2024
Mitral regurgitation, Ticker, Aix-en-Provence, Doctor of Philosophy, MD, Overalls, Physiology, Hospital, Minerva, Risk, Tricuspid valve, Mayo Clinic, Clinical professor, Death, American College, Medtech, Mitral valve, Patient, Interventional cardiology

Affluent Medical : Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.

Key Points: 
  • Affluent Medical : Excellent valve performance at 1 year follow up and rising recognition of Epygon biomimetic mitral valve.
  • The article summarizes the procedure and the follow up at 6 months, which showed continued good prosthetic performance.
  • Examination through a transesophageal echocardiogram revealed excellent valve performance, with neither mitral regurgitation nor paravalvular leak.
  • Mitral valve regurgitation is a serious and potentially fatal disease affecting 2% of the world's population, or approximately 160 million people.

Foldax, Inc. Signs Manufacturing Agreement with Dolphin Life Science India LLP to Expedite Upcoming Commercial Availability

Retrieved on: 
tisdag, februari 27, 2024
Research, Medical Devices, Engineering, Chemicals, Plastics, Health Technology, Cardiology, Manufacturing, Biotechnology, Health, Science, Anticoagulant, Cardiovascular disease, CDSCO, Sale, RHD, Calcification, Mitral valve, Patient, Anatomy, LLP, Failure, DCGI, TRIA, Medical device

Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.

Key Points: 
  • Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.
  • The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position.
  • Dolphin Life Science India LLP is an expert in manufacturing medical devices.
  • The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).

NeoChord, Inc. Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation

Retrieved on: 
torsdag, februari 22, 2024
Esophagitis, Tricuspid valve, Denervation, General partnership, Mitral regurgitation, Johnson & Johnson, Mayo Clinic, Clinical professor, Hypertension, Ethicon, Mitral valve, Patient, Disease, Pharmaceutical industry

MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.
  • The company appointed Todd Berg as Chief Executive Officer to oversee clinical and commercial programs for transeptal and transapical repair of damaged mitral valve chords resulting in regurgitation.
  • Berg has over 30 years of experience successfully developing and commercializing novel medical therapies and holds over 100 U.S. patents.
  • The opportunity to develop a first-line therapy for mitral valve disease, by resolving regurgitation early in the disease state, is incredibly compelling," said Berg.

NeoChord, Inc. Appoints New Chief Executive Officer to Lead Commercialization Efforts and Study Novel First-Line Therapy for Mitral Valve Regurgitation

Retrieved on: 
torsdag, februari 22, 2024
Esophagitis, Tricuspid valve, Denervation, General partnership, Mitral regurgitation, Johnson & Johnson, Mayo Clinic, Clinical professor, Hypertension, Ethicon, Mitral valve, Patient, Disease, Pharmaceutical industry

MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 /PRNewswire/ --  NeoChord is a privately held, medical technology company and the world-leader in beating heart delivery of artificial chords in the treatment of mitral valve regurgitation.
  • The company appointed Todd Berg as Chief Executive Officer to oversee clinical and commercial programs for transeptal and transapical repair of damaged mitral valve chords resulting in regurgitation.
  • Berg has over 30 years of experience successfully developing and commercializing novel medical therapies and holds over 100 U.S. patents.
  • The opportunity to develop a first-line therapy for mitral valve disease, by resolving regurgitation early in the disease state, is incredibly compelling," said Berg.