Cordis has announced compelling new data from two major clinical studies evaluating its SELUTION SLR Drug-Eluting Balloon (DEB) in patients with complex peripheral artery disease (PAD). The results, presented at recent international conferences, demonstrate exceptional long-term efficacy and consistent performance across diverse patient populations.
Unprecedented 3-Year Results from Japan Trial
The SELUTION SFA Japan Trial has yielded remarkable 3-year outcomes that position the sirolimus-eluting balloon as a potential game-changer in PAD treatment. In this prospective, single-arm trial conducted across 13 Japanese sites with 134 complex patients, SELUTION SLR achieved a primary patency rate of 81.5% at the 3-year mark. Additionally, freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) reached 93.8%.
Dr. Iida of the Cardiovascular Division at Osaka Police Hospital, who served as the study's Principal Investigator, emphasized the significance of these findings: "SELUTION SLR DEB represents the next evolution in Leave-Nothing-Behind treatment strategies. These 3-year outcomes demonstrate unprecedented durability in complex patients with primary patency greater than 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period."
According to Cordis, these results establish SELUTION SLR as the only drug-eluting technology with core-lab adjudicated 3-year patency exceeding 80%, a notable achievement in the field of endovascular interventions.
SUCCESS PTA Study Confirms Real-World Effectiveness
Complementing the long-term Japanese data, the SUCCESS PTA Study provided robust evidence of SELUTION SLR's effectiveness in a diverse, real-world setting. This prospective, observational global registry evaluated the device in 723 patients across 27 sites spanning Europe, Asia, and South America.
The study population reflected typical clinical practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI). At the 12-month mark, freedom from CD-TLR—the study's primary endpoint—showed consistently strong results:
- 91.1% in the overall population
- 91.3% in claudicants
- 90.3% in CLTI patients
Clinical improvements were substantial, with 88.1% of patients improving by at least one Rutherford category, indicating meaningful symptomatic relief.
Dr. Michael Lichtenberg, Chief of Interventional Angiology at Klinikum Hochsauerland and Study Principal Investigator, highlighted the technology's unique advantages: "Leveraging SELUTION SLR DEB with its unique sirolimus MicroReservoir technology delivers unequivocal clinical benefits in complex patient cohorts. These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients."
Sirolimus Delivery Platform Shows Advantages Over Paclitaxel
A key differentiator for SELUTION SLR appears to be its sirolimus-based drug delivery system, which contrasts with the paclitaxel-based approach used in many other DEBs. The sustained sirolimus release mechanism appears to contribute to the device's durable efficacy profile.
Dr. George Adams, Chief Medical Officer at Cordis, described the technology as "drug elution, done better," noting that "sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations."
The SELUTION SLR utilizes a proprietary MicroReservoir technology that enables controlled, sustained release of sirolimus into the vessel wall. This approach may address limitations seen with other drug-delivery platforms while maintaining the benefits of a leave-nothing-behind strategy that avoids permanent implants.
Implications for PAD Treatment
Peripheral artery disease affects millions globally, with treatment options historically limited by restenosis and the need for repeat interventions. The durability demonstrated by SELUTION SLR could potentially reduce the need for reinterventions, which carry both clinical and economic benefits.
The consistent performance across both claudicant and CLTI populations is particularly noteworthy, as CLTI patients represent a challenging subgroup with traditionally poorer outcomes. The ability to achieve similar results in this high-risk population suggests the technology may help address an important unmet need.
The data from these two complementary studies—one providing long-term outcomes and the other demonstrating real-world effectiveness—strengthens the evidence base for sirolimus-eluting balloon technology in PAD management. As endovascular specialists continue seeking optimal treatment strategies that balance immediate technical success with long-term durability, these findings may influence clinical decision-making and treatment algorithms.
The SELUTION SLR Drug-Eluting Balloon has been presented at the Charing Cross Symposium in London on April 23, 2025, and at the Japan Endovascular Treatment Conference in Osaka on April 25, 2025.
