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TAVR Registry Data Shows Procedure Volume-Safety Relationship

 
• By Reed Miller

Data from 113,662 procedures at 555 hospitals from 2015 to 2017 shows an inverse relationship between the number of transfemoral transcatheter aortic valve replacement (TAVR) procedures a center or operator performs and the mortality rate for those patients. These results, published in The New England Journal of Medicine, lend support for CMS’ proposal to maintain center-volume requirements in the conditions for Medicare coverage for TAVR.

closeup pen in hand's doctor notes data on medical document. - Image
• Source: shutterstock.com

New data from the Society of Thoracic Surgeons/American College of Cardiology’s Transcatheter Valve Therapy (TVT) Registry show an inverse relationship between hospitals’ and operators' transcatheter aortic valve replacement (TAVR) procedure-volume and the mortality rate associated with those procedures.

The New England Journal of Medicine published the results of the retrospective study online April 3, a week after the US Centers for Medicare & Medicaid Services (CMS) announced...

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from Business

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Edwards Lifesciences Holds 2025 EPS Outlook Despite Tariff Headwind

 
• By Shubham Singh

The brunt of the tariff exposure stems from Singapore and Costa Rica, which together account for an estimated 70% to 80% of the tariff-related cost burden. Less than 10% of the exposure is tied to China.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.