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00:00Drug-coded balloons, or DCBs, can be used to treat arterial lesions through mechanical balloon dilation.
00:19During treatment, DCBs deliver a small dose of antiproliferative drug to the arterial wall to help prevent restenosis.
00:30The Stelarex DCB is designed to treat peripheral arterial disease, or PAD, using a proprietary coating technology to produce a low-dose DCB with exemplary clinical performance.
00:43The Stelarex drug coating, called EnduroCode technology, is a hybrid mix of amorphous and crystalline paclitaxel, an antiproliferative drug combined with the excipient polyethylene glycol, PEG.
01:02Amorphous paclitaxel is durable and cohesive. However, preclinical studies show it does not stay resident in the vessel at therapeutic levels as long as crystalline paclitaxel.
01:14Crystalline 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 restenotic window in preclinical studies.
01:31Stelarex blends amorphous and crystalline paclitaxel to help prevent the proliferation of smooth muscle cells throughout the restenotic window.
01:41In DCB design, excipients can help to maximize drug adherence to the balloon during transit and drug release to the tissue upon inflation.
01:59Stelarex is designed with the distinct excipient, polyethylene glycol, or PEG.
02:04PEG is a water-soluble, hydrophilic polymer with a large molecular weight and features important mechanical properties like adhesion, elasticity, and elongation that make the coating highly adaptable to flexion, torque, elongation, and compression, resulting in high durability during handling, tracking, and inflation.
02:25Once PEG is hydrated, it swells and starts to separate paclitaxel molecules, increasing the bioactive surface area.
02:40PEG has shown a high affinity to and forms ionic bonds with hydroxyl apatite, the primary component of calcified atherosclerotic lesions, to limit drug washout in the presence of calcium.
02:55Other water-soluble excipients, such as urea, don't exhibit the same adhesive and elongating properties as PEG, and dissolve quickly due to their small, molecular weight, leaving paclitaxel exposed.
03:14Emulsifying excipients, such as polysorbate, help water-insoluble materials, like paclitaxel, dissolve in water.
03:25Due to its large molecular weight, PEG dissolves relatively slowly, protecting paclitaxel and helping to ensure a therapeutic dose reaches the lesion.
03:36Preliminally amorphous coatings can offer high durability when unhydrated, but when combined with an emulsifying excipient, the paclitaxel will dissolve quickly in blood.
04:05Research also shows a coating comprised of mostly crystalline paclitaxel may be less durable and more susceptible to flaking.
04:16The combination of a small hydrophilic excipient, like urea, with predominantly crystalline paclitaxel may cause more paclitaxel to flake off due to the excipient's rapid dissolution.
04:29Due to the hybrid coating mix of amorphous and crystalline paclitaxel and the mechanical properties of the excipient PEG,
04:46the STELAR-X Enduraco technology has been shown to be very stable during handling, transit, and inflation.
04:54This same research shows minimal amounts of paclitaxel flaking off and traveling distally.
05:05DCBs are intended to restore vessel patency while helping to prevent restenosis.
05:10Percutaneous transluminal angioplasty, or PTA, uses uncoated balloons for peripheral arterial disease treatment.
05:24A preclinical study showed a higher rate of restenosis 28 days after PTA balloon treatment compared to DCBs.
05:31In addition, STELAR-X showed a marked reduction of neo-intima hyperplasia measured by a reduced percent diameter stenosis compared to PTA.
05:43Therefore, with a low dose of only 2 micrograms per millimeter squared, STELAR-X provides a more consistent treatment effect.
05:51DCB performance is built on a critical balance of multiple factors that include the right coating morphology, the right excipient, and an optimal drug dose.
06:07The STELAR-X DCBs carefully balances these critical factors and has been demonstrated as safe and effective in multiple trials with independent assessment and adjudication of outcomes, including patency.
06:25In the first STELAR-X randomized controlled trial, called Illuminate-EU-RCT, the STELAR-X primary patency was 89% at 365 days, as independently assessed and adjudicated, the highest rate reported amongst competitive DCB RCTs.
06:47The Illuminate-EU-RCT trial achieved these results while having similar patient and lesion characteristics to both the IMPACT-SFA trial and the Lutonix-Levant-2 trial.
07:04In the STELAR-X Illuminate-Pivotal study, more complex patients were evaluated compared to the other randomized controlled trials,
07:12including 43.9% of patients reported to have severely calcified lesions, as well as more patients with diabetes, renal insufficiency, and clinical obesity.
07:26Even in a complex patient population with more comorbidities and challenging lesions,
07:31the primary patency rate at 365 days for Illuminate-Pivotal was high at 82.3%.
07:40STELAR-X has proven to be a safe treatment therapy for common to complex patients,
07:47with low clinically-driven target lesion revascularization rates in both STELAR-X RCTs.
07:56The STELAR-X drug-coded angioplasty balloon balances the right coding form, excipient, and optimal drug dose,
08:04leading to top-tier clinical outcomes in common to complex patients.
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