Chapters Transcript Video Philips Stellarex drug-coated balloon Philips Stellarex drug-coated balloon Animation D036295-04 drug coated balloons or D CBS can be used to treat arterial lesions through mechanical balloon dilation during treatment. De CBS deliver a small dose of anti proliferated drug to the arterial wall to help prevent restenosis. Oh, the stellar X D. C. B is designed to treat peripheral bacterial disease, or P A d, using a proprietary coating technology to produce a low dose DCB with exemplary clinical performance. The stellar ex drug coding, called Endure Ako Technology, is a hybrid mix of a morphosis and crystalline paclitaxel, an anti proliferated drug combined with the egg zippy in polyethylene glycol peg, a amorphous paclitaxel, is durable and cohesive. However, pre clinical studies show it does not stay resident in the vessel at therapeutic levels as long as crystal and paclitaxel. Crystal and paclitaxel allows the formation of drug depots to aid sustained release, keeping the drug resident in the vessel at therapeutic levels for at least 28 days. The critical Reston Arctic window in pre clinical studies. Still, Rex blends amorphous and crystal and paclitaxel to help prevent the proliferation of smooth muscle cells throughout the rest. In Arctic Window in D. C. B design experience can help to maximize drug adherence to the balloon during transit and drug released to the tissue upon inflation. Stella Rex is designed with the distinct exit p int polyethylene glycol, or Peg. Peg is a water soluble hydrophobic polymer with a large molecular weight and features important mechanical properties like adhesion, elasticity and elongation. But make the coding highly adaptable to flexion torque, elongation and compression, resulting in high durability during handling, tracking and inflation. Once peg is hydrated, it swells and starts to separate paclitaxel molecules. Increasing the bio active surface area Peg has shown a high affinity to and forms ionic bonds with hydroxy appetite. Primary component of calcified. Authorize sclerotic lesions to limit drug. Wash out in the presence of calcium. Other water soluble experience such as Yuria. Don't exhibit the same adhesive and elongating properties as peg and dissolve quickly due to their small molecular weight, leaving paclitaxel exposed in most defying exit peons such as probably sore bait. Help water insoluble materials like paclitaxel dissolve in water due to its large molecular weight. Peg dissolves relatively slowly, protecting paclitaxel in helping to ensure a therapeutic dose reaches the lesion. Yeah, predominantly amorphous coatings can offer high durability when unhygienic did. But when combined with an impulse, if eyeing exit P int, the paclitaxel will dissolve quickly. And blood research also shows a coding comprised of mostly crystal and paclitaxel, maybe less durable and more susceptible to flaking combination of a small hydro filic. X IPI int like curia with predominantly crystal and paclitaxel, may cause more paclitaxel to flake off due to the exit peons, rapid disillusion, the witht brid coating mix of amorphous and crystalline paclitaxel, and the mechanical properties of the exit peon peg, the Stella Rex and Yuriko Technology has been shown to be very stable during handling transit and inflation. The same research shows minimal amounts of paclitaxel, flaking off and traveling distantly. De CBS are intended to restore vessel Peyton C while helping to prevent restenosis per cutaneous. Trans Luminal angioplasty, or P. T. A uses uncoated balloons for peripheral arterial disease treatment. Ah, pre clinical study showed a higher rate of restenosis 28 days after PT a balloon treatment compared to D. C. B s. In addition, Stella Wreck showed a marked reduction of neo intimate hyperplasia measured by a reduced percent diameter stenosis compared to P. T. A Therefore, with a low dose of only two micrograms per millimeter squared, Celebrex provides a more consistent treatment effect. D C B performance is built on a critical balance of multiple factors that include the right coding morphology, the right exit P int and an optimal drug dose. Stella Rex DCB carefully balances thes critical factors and has been demonstrated as safe and effective in multiple trials with independent assessment and adjudication of outcomes, including Peyton C. E. In the first Stella Rex randomized controlled trial called Illuminate You RCTI, the Stella Rex primary, Peyton C was 89% at 365 days as independently assessed and adjudicated, the highest rate reported amongst competitive D c B R C T s Theo Illuminate you RCT trial achieved these results while having similar patient and lesion characteristics to both the Impact S F A trial and the Luton iXL event to trial in this Stella Rex illuminate pivotal study. More complex patients were evaluated compared to the other randomized controlled trials, including 43.9% of patients reported to have severely calcified lesions. Aziz well as more patients with diabetes, renal insufficiency and clinical obesity even in a complex patient population with more co morbidity, ease and challenging lesions. The primary Peyton C rate, at 365 days for Illuminate Pivotal was high at 82.3%. Stella Rex has proven to be a safe treatment therapy for common to complex patients with low, clinically driven target lesion revascularization rates in both stellar X r C. T s Stella Rex, drug coated angioplasty balloon balances, the right coding form, X IPI int and optimal drug dose, leading to top tier clinical outcomes in common, too complex patients. Published January 18, 2021 Created by
