Boston Scientific Scores CE Mark For Drug-Eluting PAD Stent
Boston Scientific has received a CE mark for its Eluvia Drug-Eluting Stent System for patients with peripheral artery disease (PAD) affecting arteries above the knees. Starting immediately, the company will begin marketing the device in the E.U. and plans to launch a clinical trial aimed at regulatory approval in the U.S. and Asia, with results expected in early 2018.
An estimated 8 million Americans suffer from PAD, a narrowing of blood vessels that restricts blood flow to extremities (usually legs), which may cause pain and possible disability, according to the Center for Disease Control. Patients whose disease cannot be managed with medication or lifestyle changes alone may be candidates for angioplasty, a minimally invasive surgical procedure that places a stent in the narrowed artery to restore blood flow.
Eluvia is the first drug-eluting polymer stent to be approved in Europe for cases of PAD that occur above the knee, specifically in the superficial femoral artery (SFA) and proximal popliteal artery, according to a Boston Scientific press release. Over time, the stent releases a drug called paclitaxel, which reduces the likelihood of restenosis.
In September, Boston Scientific presented 12 month clinical data for the device, in which 94 percent of patients presented with little or no leg pain in the year following angioplasty and only 3.8 percent of patients experienced target lesion revascularization (TLR). These pivotal results, said the company, secured the CE Mark.
“Achieving a 96 percent primary patency rate at one year, with low major adverse events, is exceptional,” said Stefan Muller-Hulsbeck, the trial’s principal investigator, in a press release. “In my opinion, the sustained release of paclitaxel enabled by this technology could represent a significant advancement in the treatment of patients with PAD.”
The FDA has issued an Investigational Device Exception (IDE) for Eluvia that will allow Boston Scientific to launch a clinical trial in the U.S. this year. The Imperial trial will enroll 485 patients at 75 sites worldwide and will compare safety and efficacy profiles of Eluvia with Cook Medical’s Zilver PTX Stent, which was the first drug-eluting stent indicated for PAD approved in the U.S.
Jeff Mirviss, senior VP and president of Peripheral Interventions at Boston Scientific, remarked that the CE Mark is a testament to the momentum of the company’s drug-eluting portfolio. “Our legacy with drug-eluting technology, combined with our commitment to further advanced treatment options for PAD, enables Boston Scientific to continue brining ground breaking solutions for patients around the world.”
In a recent earnings call, Boston Scientific CEO Michael Mahoney announced that the company would be launching its core SFA stents in Asia this year, an expanding market for its PAD portfolio.
“We were light weight in terms of the emerging markets in PAD five years ago, and we put a lot of investment in there,” said Mahoney. “We’re starting to see that become more meaningful in places like China and Brazil.”