Boston Sci nabs first CE mark for drug-polymer combo stent for above-the-knee PAD

Eluvia Drug-Eluting Vascular Stent System--Courtesy of Boston Scientific

Boston Scientific ($BSX) won a CE mark for its Eluvia Drug-Eluting Vascular Stent System to treat peripheral artery disease (PAD) patients with narrowing of the arteries above the knee. It will launch the product immediately in the EU and has already started a pivotal trial aimed at U.S. and Asia approvals, with primary endpoint data due in early 2018.

Eluvia is a drug-polymer combo stent, which the company notes is the first such stent approved in Europe for above-the-knee PAD. This also makes Boston Scientific the first company with a drug-eluting stent and a drug-eluting balloon, observed Boston Scientific President and CEO Michael Mahoney on the year-end earnings call in early February.

Eluvia uses the anti-restenotic drug paclitaxel in conjunction with a polymer; it offers sustained release of the drug over the time restenosis is most likely to occur, thereby preventing tissue growth that might have blocked the stented artery.

Last quarter, the company started enrollment for the IMPERIAL trial to test Eluvia as compared to the Zilver PTX Stent from Cook Medical. The trial is aimed at undergirding U.S. and Asia approvals in the above-the-knee PAD indication and will include about 485 patients at 75 sites worldwide.

IMPERIAL is slated to report data on primary outcome measures--which are major adverse events over 12 months and primary patency of the target lesion at 12 months as assessed by duplex ultrasound at an independent lab--in January 2018 with completion of the trial in January 2022.

The CE mark was based on the prospective, multicenter clinical trial MAJESTIC, which found Eluvia had a primary patency rate of more than 96%. That's the highest 12-month patency rate reported for an interventional treatment of femoropopliteal artery lesions among comparable trials, according to Boston Scientific.

"The exceptional 12-month results presented in the MAJESTIC trial, which included a high percentage of patients with complex lesions, demonstrate that this technology is a safe and efficacious solution for patients needing stents for the treatment of peripheral artery disease," said Dr. Stefan Müller-Hülsbeck, principal investigator at the Vascular Center Diako Flensburg and head of the Department of Diagnostic and Interventional Radiology and Neuroradiology at the Academic Hospitals in Flensburg, Germany, in a statement. "The approval is a testament to the strength of the data, and will be welcome news to physicians and patients who have not previously had access to a polymer based, drug-eluting stent, specifically developed for the superficial femoral and proximal popliteal arteries."

- here is the announcement