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FDA Data Raise Red Flags for Suture-Based Vascular Closure Devices

February 11, 2021
Suture-based vascular closure devices (VCDs) can, in real-world practice, lead to complications and even death, analysis of a US Food and Drug Administration database confirms. These adverse outcomes varied by whether the VCD in question was the decades-old Prostar XL or the newer Perclose ProGlide (Abbott), which arrived on the US market in 2018.
The researchers caution, however, that the data they report don’t capture the true incidence, since the “denominator” of the total case count over the years is hard to pin down.
Use of large-bore closure devices is expected to rise given the growth in TAVI and structural heart procedures, percutaneous left ventricular assist device implantation, and endovascular interventions. Beyond the suture-based VCDs, other designs have now arrived for instance, following results from the SAFE-MANTA trial, the Manta (Essential Medical), which combines a bioresorbable collagen plug and suture system to seal the pun ....

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Vascular Closure Devices Market - Analysis, Segments, Growth And Value Chain Till 2023

Vascular Closure Devices Market – Analysis, Segments, Growth And Value Chain Till 2023 ....

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