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, Reports Medical Device News Magazine

Surmodics, a leading provider of medical device technologies, is set to present the 24-month data from its SWING (SurVeil™ Drug-Coated Balloon for the Treatment of Femoropopliteal In-Stent Restenosis) trial at the upcoming VEITHsymposium on November 15. This highly anticipated presentation will shed light on the long-term efficacy and safety of Surmodics’ SurVeil™ drug-coated balloon (DCB) in treating patients with femoropopliteal in-stent restenosis.

The SWING trial is a pivotal, single-arm, prospective study that evaluated the performance of Surmodics’ SurVeil™ DCB in patients with peripheral artery disease (PAD) suffering from femoropopliteal in-stent restenosis. In-stent restenosis occurs when a previously placed stent becomes narrowed or blocked again due to the re-growth of tissue within the stent. This condition poses a significant challenge for physicians, as it limits blood flow and can lead to severe complications if left untreated.

The SurVeil™ DCB is designed to address this issue by delivering a proprietary drug, paclitaxel, to the affected area while minimizing the risk of systemic exposure. Paclitaxel has been proven to inhibit cell growth and prevent re-narrowing of blood vessels. Surmodics’ innovative technology incorporates a unique drug-excipient formulation that allows for sustained drug release over an extended period, ensuring optimal therapeutic effect.

The 24-month data from the SWING trial will provide valuable insights into the long-term outcomes of using Surmodics’ SurVeil™ DCB in treating femoropopliteal in-stent restenosis. The trial enrolled 446 patients across 47 sites in the United States and Europe, making it one of the largest studies of its kind. The primary endpoint of the trial is primary patency, which measures the rate of vessel re-narrowing or re-occlusion.

The presentation at the VEITHsymposium will include detailed analyses of primary patency rates, target lesion revascularization rates, and other key clinical outcomes. These data will help clinicians and researchers better understand the effectiveness and safety profile of Surmodics’ SurVeil™ DCB in treating this challenging condition.

Dr. Gary Ansel, the primary investigator of the SWING trial, expressed his excitement about the upcoming presentation, stating, “The 24-month data from the SWING trial will provide critical information on the long-term performance of Surmodics’ SurVeil™ DCB. This data will be instrumental in guiding clinical decision-making and improving patient outcomes.”

Surmodics’ commitment to advancing medical device technologies is evident in its investment in rigorous clinical trials like the SWING trial. The company aims to provide physicians with innovative solutions that address unmet needs in patient care. By presenting the 24-month data at the VEITHsymposium, Surmodics aims to contribute to the scientific community’s understanding of femoropopliteal in-stent restenosis treatment options.

In conclusion, Surmodics’ upcoming presentation of the 24-month data from the SWING trial at the VEITHsymposium is highly anticipated by the medical community. This data will provide valuable insights into the long-term efficacy and safety of Surmodics’ SurVeil™ DCB in treating femoropopliteal in-stent restenosis. By investing in rigorous clinical trials and sharing their findings, Surmodics continues to demonstrate its commitment to improving patient outcomes and advancing medical device technologies.

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