Stellarex achieves the highest 1 year patency (89.0%) of any DCB in patients with similar characteristics, and top-tier patency in the most complex patient set studied in a DCB RCT, including the highest rates of severely calcified lesions.
The true measure of Stellarex performance is its top-tier patency in challenging lesions and comorbidities, including severe calcium, diabetic patients, renal insufficiency, female patients and clinically obese patients. In addition, Stellarex DCB RCTs studied 422 patients, compared to In.Pact (N = 200) and Lutonix (N = 312).
“The Stellarex DCB has shown safety and efficacy in a cohort of patients, which included a higher preponderance of diabetics and core-lab defined severely calcified lesions in the US IDE trial. These results, in combination with the cohort of patients studied in the EU RCT, demonstrate that the Stellarex DCB is safe and effective in diverse patient populations when addressing symptomatic femoropopliteal disease. ”
Consistently low CD-TLR rates demonstrate the safety of Stellarex in common-to-complex patients.
Significant treatment effect observed out to 2 years and increasing from 1 to 2 years.
Stellarex is the only commercially available DCB for the SFA with two reported randomized controlled trials, four clinical trials (N = 1,079)6 and the largest number of randomized patients (N = 628)6. Across clinical trials, Stellarex delivers consistent results.
“Stellarex is the first low-dose DCB to demonstrate a significant treatment effect at 2 years. ”