Integra Lifesciences ((IART)) announced an update on their ongoing clinical study.
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Integra LifeSciences is conducting a study titled ‘A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter’ to evaluate the safety of the Bactiseal catheter in patients with hydrocephalus. The study aims to monitor adverse events within two years post-implantation, providing crucial safety data for this medical device.
The intervention involves the use of an antibiotic-impregnated catheter designed to shunt cerebrospinal fluid in hydrocephalus patients, aiming to reduce infection risks associated with catheter use.
This observational study is retrospective and cohort-based, involving 200 subjects across multiple centers. It focuses on collecting data from medical records to assess adverse events and potential infections post-implantation.
The study began on February 8, 2024, with the latest update submitted on January 23, 2025. These dates are significant as they mark the study’s progress and ongoing data collection efforts.
The study’s findings could influence Integra LifeSciences’ stock performance by providing insights into the safety of their product, potentially affecting investor sentiment. The results may also impact the competitive landscape in the medical device industry, particularly in the market for hydrocephalus treatment solutions.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.