Initial experience with innovative new stent delivery system
Published date : 27 April 2010
Article date : 27 April 2010
Recently, the Department of Angiology at the Park Hospital, Leipzig, participated in the initial release of the SUPERA VERITAS Peripheral Vascular Stent delivery system. Compared to previous generations of SUPERA stent delivery systems, they experienced significant improvements and found that SUPERA VERITAS provides the operator with a smooth and controlled deployment of the SUPERA stent. The system also incorporates ease of use by significantly reducing the number of steps needed to prep and deliver the stent.
According to Dr Dierk Scheinert, Leipzig, Germany, “In our department we have been utilising the SUPERA stent clinically for over two years and we have been very impressed with the performance of the stent and positive clinical outcomes. Even in the most challenging anatomy, the SUPERA stent has delivered the strength and flexibility to accommodate the most challenging vessels in the femoropopliteal region. The interwoven nitinol stent is truly a differentiated platform that produces best in class radial strength without sacrificing flexibility or durability. In our experience we have learned that this differentiated platform requires different vessel preparation and sizing considerations compared to using ‘slotted tube’ stents.”
He further explained that it is important to prepare the vessel to the outer diameter of the stent and size the outer diameter of the stent 1:1 to the vessel. Due to the increased radial strength of SUPERA, there is no need to oversize the stent and doing so will actually compromise the performance and accuracy of the stent.
There are several ongoing studies to evaluate the clinical performance of SUPERA including the Leipzig Registry at Park Hospital and the SUPERB clinical trial.
In the Leipzig Registry, the researchers have follow-up on 107 patients with lesions in the superficial femoral artery (SFA) and 76 patients with popliteal obstructions treated with the SUPERA stent. The initial data shows high patency rates of >85% at 12 months in both locations and no fractures even in the popliteal segment.
“This is very exciting and I believe that this could be a ‘game changing’ technology for stenting in the peripheral space,” explained Scheinert.
The SUPERB (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) trial is a prospective, single-arm trial of 258 patients at up to 38 U. sites and two European sites. The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity. This trial is currently enrolling patients.
In conclusion, Scheinert believes that the SUPERA VERITAS delivery system is much improved and provides smooth and easy delivery of the SUPERA stent. The SUPERA stent has proven to be a significant advancement in stent technology and its unique characteristics allow physicians to treat areas where standard ‘slotted tube’ nitinol stents have always encountered difficulty.
