India-based Meril Life Sciences has been manufacturing its Myval transcatheter heart valves for years, but the technology has not yet gained FDA approval. This latest head-to-head comparison included data from more than 1,000 TAVR patients.
The advanced machine learning model tracks more than 50 different factors to make its predictions. It has already been found to be more accurate than popular prediction methods for heart disease that are currently available.
Paravalvular leak has been shown to impact patient outcomes after TAVR. Higher degrees of valve oversizing, however, can reduce the risk of post-treatment PVL without increasing the odds of adverse outcomes.
“This is the perfect technique to identify high-risk patients who would benefit from intensive therapies,” imaging specialist Gudrun Feuchtner, MD, told Cardiovascular Business.
A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.
The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death.
A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.
The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death.
Coronary artery disease is both underdiagnosed and undertreated in women, and they often receive less guideline-recommended care than men. Why do these disparities persist? And what can today’s healthcare providers do to bring about change?
“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."
