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Cordis Unveils Significant Advances in Peripheral Artery Disease Treatment

In a notable advancement for cardiovascular care, Cordis has announced promising results from two significant studies regarding its SELUTION SLR™ Drug-Eluting Balloon (DEB), underscoring its efficacy in treating complex Peripheral Artery Disease (PAD).

Strong Outcomes from the SELUTION SFA Japan Trial

The first major study, the SELUTION SFA Japan Trial, examined a total of 134 complex patients under a prospective, single-arm format at 13 sites in Japan. This extensive research demonstrated that SELUTION SLR™ DEB boasts a remarkable primary patency rate of 81.5% over a three-year period. Additionally, patients in this study exhibited a freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) rate of 93.8%. Such statistics position the SELUTION SLR™ as a frontrunner among drug-eluting technologies, presenting the highest reported patency rates for drug-eluting devices to date. Dr. Iida, the Study Principal Investigator at Osaka Police Hospital, emphasized that these findings showcase an unprecedented durability in a challenging patient demographic, providing a deeper understanding of the long-term benefits of this innovative therapeutic approach.

The SUCCESS PTA Study: Real-World Implications

Following on the heels of this success, the SUCCESS PTA Study expanded on these findings by evaluating SELUTION SLR™ DEB's performance in a more diverse and real-world patient population. Conducted across 27 sites in Europe, Asia, and South America, this observational study included 723 patients, with a notable 74.2% of them presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI). The results were striking: the primary endpoint of freedom from CD-TLR after 12 months reached 91.1% in the overall population, 91.3% in claudicants, and 90.3% in patients with CLTI, indicating a consistently high level of effectiveness. The study showcased not only the safety of the device but also clinical improvements across various patient cohorts, with 88.1% of patients observing enhancements in their Rutherford category status.

Innovative Drug Elution Technology

One of the standout features of the SELUTION SLR™ DEB is its unique sirolimus MicroReservoir technology, designed to facilitate sustained drug release. This innovative approach ensures a more effective treatment process, allowing for significant clinical benefits among challenging patient groups. Dr. Michael Lichtenberg, the Chief of Interventional Angiology at Klinikum Hochsauerland and another Principal Investigator of the study stressed, "Leveraging SELUTION SLR™ DEB with its unique sirolimus MicroReservoir technology delivers unequivocal clinical benefits in complex patient cohorts."

Advancing Patient Care Beyond Expectations

With the ongoing commitment to refine therapeutic strategies that yield substantial long-term impacts on patient wellbeing, Cordis's recent studies play a crucial role in shaping the future of cardiovascular interventions. Dr. George Adams, Chief Medical Officer at Cordis, remarked, "The SELUTION SLR™ studies showcase drug elution, done better – sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations."

Looking Ahead

The substantial findings from these two pivotal studies not only bolster the evidence supporting the SELUTION SLR™ DEB but also illuminate a path towards improved management of peripheral artery disease in complex patients – a significant leap towards enhanced patient care in cardiovascular medicine. As Cordis continues its mission to innovate, the implications of these results could transform everyday practices in interventional cardiology. For more information about Cordis and its pioneering technology, visit Cordis.com.