The SUPERB pivotal clinical trial has shown positive clinical data for the Supera Peripheral Stent System (IDEV Technologies) in treating patients with obstructive superficial femoral artery disease. Kenneth Rosenfield, Section head for Vascular Medicine and Intervention at Massachusetts General Hospital and study co-principal investigator, presented the 12-month outcomes in the Late Breaking Trials session at the Vascular Interventional Advances (VIVA) 2012 (Las Vegas, USA, 9–12 October 2012).
“In the SUPERB trial, the Supera stent achieved one-year patency rates not previously achieved in a pivotal trial for any stent placed in the superficial femoral artery (SFA) and proximal popliteal artery,” said Rosenfield. “The unique design of the Supera stent and its combination of flexibility and radial strength may account for this stent’s ability to restore durable patency.”
In addition, this is the first and only femoral-popliteal artery investigational device exemption trial to record zero stent fractures for nitinol-based technologies.
The SUPERB study (Comparison of the Supera peripheral system to a performance goal derived from balloon angioplasty clinical trials in the superficial femoral artery) enrolled 264 patients at 34 centres across the USA, treating 266 lesions with a mean length of 8cm. De novo or restenotic lesions in the superficial femoral and proximal popliteal arteries of 40-140mm in length were enrolled. Key results included:
- The primary safety endpoint of freedom from death, target lesion revascularisation (TLR) or any amputation of the index limb to 30 days post-procedure, was met by 99.6% of the patients.
- The study also exceeded the primary efficacy endpoint with a statistically significant improvement over the objective performance goal established by the FDA and VIVA physicians, including for vessel patency at one year.
- Based on survival analysis, the Supera stent achieved freedom from loss of primary patency at one year of 86%.
- Freedom from TLR of 90%
The SFA and proximal popliteal artery are exposed to significant mechanical stress with bending and rotation of the knee, which represents a harsh environment for any endovascular device. An ideal stent for use in these areas should offer a significant range of motion without interrupting the anatomical function of the arteries.
“Supera is first in a new class of stents engineered with an interwoven wire technology that best mimics vascular anatomy. These results challenge the current dogma of other stent and drug-eluting stent technologies to achieve optimal and durable femoropopliteal arterial patency,” said co-primary investigator Lawrence Garcia, chief, Interventional Cardiology and Vascular Interventions at Steward St Elizabeth’s Medical Center, Boston, USA.
Data from the SUPERB trial will be used for IDEV’s premarket approval application with the FDA.
SUPERB data analysis was performed independently and validated by the Harvard Clinical Research Institute (HCRI).
The SUPERA stent is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in multiple other countries for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty.