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| Eluvia drug-eluting stent--Courtesy of Boston Scientific |
Boston Scientific ($BSX) announced that its drug-eluting peripheral stent achieved the highest 12-month primary patency rate among other investigational devices to treat blocked arteries in the leg, a sign of peripheral artery disease.
The Eluvia Drug-Eluting Vascular Stent System achieved a primary patency rate of greater than 96%, the company said at presentation of 12-month, 57-patient clinical trial data during the Interventional Radiological Society of Europe (CIRSE) annual meeting in Lisbon, Portugal.
Patency refers to the ability of the stent to remain anchored to the inside of the vessel wall and stay open following implantation. The Eluvia is implanted in the thigh's superficial femoral artery and the knee's proximal popliteal artery.
The device is pending CE-mark approval. Boston Scientific also announced that it has received an Investigational Device Exemption from the FDA to begin a global pivotal trial for U.S. approval. The study will begin enrolling patients soon.
In addition, Boston Scientific reported a low rate of 12-month target lesion revascularization (or repeat interventions at the site of the blockage) of 3.8%, as well as no observed stent fractures or amputations (which are the end result of severe cases of untreated PAD).
The main feature of the Eluvia, is its release of the drug paclitaxel to reduce restonois, or a renarrowing of the artery following implantation. The recently approved Innova bare-metal stent will serve as the platform for the Eluvia.
Paclitaxel is widely used in drug-eluting stents to treat stenosis in the coronary artery. But drug-eluting stents are not the standard of care for the treatment of PAD. Usually, standard bare metal stents are implanted following angioplasty. Angioplasty physically removes blockages via an inflated balloon, but often injures the vessel wall in the process, resulting in the need for peripheral stents.
New drug-eluting angioplasty balloons from Medtronic ($MDT) and C.R. Bard ($BCR) are off to a good start in the U.S. Boston Scientific's Eluvia offers another form of drug delivery for the treatment of PAD.
The company sells drug-coated angioplasty balloons for PAD and coronary artery disease in Europe. It has agreed to distribute Bard's Lutonix drug-coated balloon for PAD in the U.S.
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