Effects of external crushing forces on a novel below-the-knee vascular implant.

BACKGROUND: The Tack Endovascular System® is a novel vascular implant designed to focally treat dissections with low radial force and minimal metal burden. As there are currently no approved below-the-knee (BTK) implants in the USA, a unique, 3-stage model was developed to characterize crush deformation and fracture potential of the Tack Endovascular System in BTK arteries. METHODS: First, 35 Tack® implants were deployed bilaterally in the posterior tibial, anterior tibial, and peroneal arteries of 3 cadavers, and clinically relevant external forces were applied to simulate BTK crushing deformation including focal load, leg crossing, and leg bending. Intravascular ultrasound images of the implanted vessels were used to assess the magnitude of artery deformation. Outputs of the cadaver testing were input into a finite element analysis (FEA) model to determine the appropriate conditions for subsequent bench testing. Tack implants were then subjected to increasing crush forces at 30Hz for up to 650,000 cycles at 25% flat plate deformation within the worst-case FEA test condition. RESULTS: Crush deformation across all arteries ranged from 0% to 23.1%. The posterior tibial artery and large male cadaver exhibited the most vulnerability to external crush forces, while the small female model exhibited the most resistance. No fractures were observed during cadaver or bench testing. CONCLUSIONS: This study characterized deformation forces in tibial arteries during various loading conditions. Tack implants withstood the loading conditions without fracture within the limits of this ex-vivo human vascular model and in-vitro bench testing.

Controlled delivery of paclitaxel from stent coatings using novel styrene maleic anhydride copolymer formulations.

The controlled release of paclitaxel (PTx) from stent coatings comprising an elastomeric polymer blended with a styrene maleic anhydride (SMA) copolymer is described. The coated stents were characterized for morphology by scanning electron microscopy (SEM) and atomic force microscopy (AFM), and for drug release using high-performance liquid chromatography (HPLC). Differential scanning calorimetry (DSC) was used to measure the extent of interaction between the PTx and polymers in the formulation. Coronary stents were coated with blends of poly(b-styrene-b-isobutylene-b-styrene) (SIBS) and SMA containing 7% or 14% maleic anhydride (MA) by weight. SEM examination of the stents showed that the coating did not crack or delaminate either before or after stent expansion. Examination of the coating surface via AFM after elution of the drug indicated that PTx resides primarily in the SMA phase and provided information about the mechanism of PTx release. The addition of SMA altered the release profile of PTx from the base elastomer coatings. In addition, the presence of the SMA enabled tunable release of PTx from the elastomeric stent coatings, while preserving mechanical properties. Thermal analysis reveled no shift in the glass transition temperatures for any of the polymers at all drug loadings studied, indicating that the PTx is not miscible with any component of the polymer blend. An in vivo evaluation indicated that biocompatibility and vascular response results for SMA/SIBS-coated stents (without PTx) are similar to results for SIBS-only-coated and bare stainless steel control stents when implanted in the non-injured coronary arteries of common swine for 30 and 90 days.