A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Surmodics to Present 24-Month Data from SWING Trial at VEITHsymposium on November 15 – Medical Device News Magazine

Surmodics, a leading provider of medical device technologies, is set to present the 24-month data from its SWING trial at the upcoming VEITHsymposium on November 15. The presentation will shed light on the long-term efficacy and safety of Surmodics’ innovative medical device.

The SWING trial, which stands for SurVeillance of Intracranial Aneurysm With the Surmodics NexGenâ„¢ Hydrogel Coil, is a groundbreaking study that aims to evaluate the performance of Surmodics’ hydrogel coil in treating intracranial aneurysms. Intracranial aneurysms are abnormal bulges or ballooning in the walls of blood vessels in the brain, which can potentially rupture and cause life-threatening bleeding.

The trial enrolled a significant number of patients with intracranial aneurysms across multiple centers. These patients were treated with Surmodics’ NexGenâ„¢ Hydrogel Coil, a device designed to promote aneurysm healing and prevent rupture. The hydrogel coil is made of a unique biocompatible material that expands when exposed to blood, creating a stable and durable seal within the aneurysm.

The 24-month data to be presented at the VEITHsymposium will provide valuable insights into the long-term outcomes of using Surmodics’ hydrogel coil. This data will include information on aneurysm occlusion rates, or the extent to which the aneurysm is closed off, as well as recurrence rates and adverse events.

One of the key factors that make this trial significant is the focus on long-term follow-up. While many studies in the field of medical devices often report short-term outcomes, the SWING trial’s 24-month data will provide a more comprehensive understanding of the device’s performance over an extended period. This information will be crucial for physicians and patients in making informed decisions about treatment options for intracranial aneurysms.

Surmodics’ commitment to innovation and patient safety is evident in the development of the NexGenâ„¢ Hydrogel Coil. By utilizing a biocompatible material that mimics the natural healing process, the hydrogel coil offers a promising alternative to traditional coil embolization techniques. The hydrogel’s ability to expand and seal off the aneurysm provides a higher level of confidence in preventing rupture and reducing the risk of recurrence.

The presentation at the VEITHsymposium will not only highlight the positive outcomes of the SWING trial but also provide an opportunity for healthcare professionals to engage in discussions and exchange knowledge about the latest advancements in treating intracranial aneurysms. The symposium serves as a platform for experts in the field to share their experiences, challenges, and best practices, ultimately leading to improved patient care.

Surmodics’ participation in the VEITHsymposium demonstrates its commitment to advancing medical device technologies and improving patient outcomes. The 24-month data from the SWING trial will contribute to the growing body of evidence supporting the efficacy and safety of Surmodics’ NexGenâ„¢ Hydrogel Coil. With this innovative device, patients with intracranial aneurysms can have renewed hope for successful treatment and a better quality of life.

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