Single Pass’ KRONOS device. Credit: PRNewswire/Single Pass.

Medical devices company Single Pass has announced the completion of the first live clinical cases in Italy for its KRONOS biopsy closure device.

KRONOS has demonstrated its potential to transform biopsy procedures by ensuring precise and effective closure post-biopsy.

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The procedures were carried out at the Universitario Campus Bio Medico, Fondazione Policlinico in Rome, Italy.

The first case involved a kidney biopsy, where a 22cm Single Pass KRONOS device was used in conjunction with a 13cm biopsy needle.

Under CT guidance, the device achieved successful cauterisation, with the depth gauge ensuring accurate targeting and results.

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A second procedure was performed on an 80-year-old female patient who underwent a liver biopsy.

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Despite significant bleeding post-tissue sample removal, the 17cm Single Pass KRONOS device provided ‘excellent visibility’ under ultrasound guidance, leading to ‘perfect track closure and full cauterisation’.

Single Pass said that the design of the device allowed for visual feedback and ease of use, particularly under ultrasound guidance.

Both primary physician operators highlighted the device’s usability and performance, noting its success in cauterising the biopsy channel and stopping post-biopsy bleeding effectively.

In a press statement Single Pass said: “The success of these initial real-life cases highlights the immense potential of the Single Pass KRONOS biopsy closure cauterisation device. With its exceptional performance and ease of use, the Single Pass KRONOS device is poised to revolutionise the field of biopsy closure.”

In January 2024, Single Pass signed an exclusive distribution agreement with Mermaid Medical Group to bring its advanced biopsy closure device to the US market.