Integra Lifesciences ((IART)) announced an update on their ongoing clinical study.
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Study Overview: Integra LifeSciences is conducting a post-market clinical follow-up study titled Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve. The study aims to assess the long-term performance and safety of the CODMAN CERTAS Plus Programmable Valve in patients with various conditions such as hydrocephalus and brain tumors. This study is significant as it provides valuable data on the device’s real-world effectiveness.
Intervention/Treatment: The study focuses on the CODMAN CERTAS Plus Programmable Valve, a medical device designed to manage cerebrospinal fluid in patients with conditions like hydrocephalus. The valve is implanted in patients to help regulate fluid flow according to specific medical needs.
Study Design: This is an observational cohort study with a prospective time perspective. The study does not involve random allocation or masking, as it primarily aims to observe and collect data on the device’s performance in a real-world setting.
Study Timeline: The study began on May 25, 2022, and is currently recruiting participants. The latest update was submitted on November 19, 2024. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: The ongoing study could influence Integra LifeSciences’ stock performance by providing evidence of the device’s effectiveness, potentially boosting investor confidence. As the medical device industry is competitive, positive outcomes could enhance the company’s market position relative to competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.