Medical Device Daily
The FDA has allowed a new company to enter the potentially lucrative carotid artery stent market. The newest member to this club is ev3 (Plymouth, Minnesota) which reported last week that the agency had approved its Prot g RX carotid stent.
The company said that the stent, when used in conjunction with its SpidRX embolic protection device, is indicated for the treatment of carotid artery disease in patients who are at high-risk for adverse events from carotid artery surgery. The SpideRX was cleared by the FDA for use in the carotid artery in February 2006.
The company joins some larger competitors, including Abbott Laboratories (Abbott Park, Illinois) and Boston Scientific (Natick, Massachusetts) who have RX versions of the stent approved in the U.S.
The FDA approval was supported by the CREATE (Carotid Revascularization with ev3, Arterial Technology Evolution) trial demonstrating the safety and effectiveness of the Prot g stent and the Spider embolic protection device when used together to treat carotid artery disease patients at risk for stroke and also at high-risk for adverse events from surgery.
The CREATE Trial enrolled 419 patients in 31 centers in a prospective, non-randomized study. The results of the trial compared favorably with performance criteria that were based on the results of previous carotid stenting trials.
According to Jim Corbett, ev3’s president and CEO, the Prot g and the SpideRX were developed separately, and the SpideRX is part of a platform technology.
“We envisioned two and possibly three markets segments long-term for it. One was in the carotid, the second would be in the saphenous vein graft and the third would be in peripheral applications,” he told Medical Device Daily. “One of the reasons that we designed it with a wire-of-choice feature is so that you would have that kind of flexibility.
Separately, he said, the company made a decision to pursue a carotid stent product line and program.
Corbett said the Prot g RX is available in both straight and tapered stent configurations providing a variety of device options to address a broad range of patient anatomy present in carotid artery disease. The “rapid exchange” platform allows for a single physician to operate the device as compared to “over-the-wire” designs that require multiple operators.
Corbett noted that while the RX is the most widely used type of carotid stent today with more than 95% adoption by physicians, the company’s program does includes over-the-wire and tapered versions of the device as well to offer “the range of carotid stenting platforms that the physician might want to use.”
According to Corbett, because it became apparent that it was clear that you had to test the stent and embolic protection device together in order to get an approval. Initially, the company received an approval to use the SpideRX in conjunction with an RX Acculink stent developed by Guidant (Indianapolis). The CREATE trial, he said, was then designed to “marry” the company’s two propietary technologies.
Carotid arteries, located on either side of the neck, are the main blood vessels providing blood flow to the brain. When carotid arteries are narrowed by atherosclerotic disease, patients are at risk for ischemic stroke. Stroke is the third leading cause of death in the U.S., affecting nearly 700,000 Americans each year, with about 30% of strokes being caused by embolic debris that originates in diseased carotid arteries. Traditionally, carotid artery disease has been treated with an open surgery called endarterectomy. However, for the many patients who are at high risk for surgery, carotid stenting has evolved as a viable option.
“We believe that the unique attributes of both the Prot g RX and SpideRX will permit ev3 to be a strong competitor in the carotid stenting market that we estimate could reach $250 million worldwide in 2007,” said Corbett.
The market for carotid stents, Corbett said is pretty nice “with still a relatively narrow reimbursement.” He said that he hopes that soon the indications for the stent will be as broad as that of carotid endarterectomy, a surgical procedure involving a vertical incision in the neck and artery and removal of the plaque. “We think the $250 million market this year will be a $1 billion market sometime within the next three years.”
Corbett noted that the company has begun an immediate launch of the Prot g , which is intended to be sold in conjunction with the SpideRX.
“What might be unique is that we are going to be promoting carotid stenting and embolic protection through both of our sales forces. The peripheral vascular disease sales force . . . and our neurovascular division, because a lot of neurointerventionalists do carotid stenting as well. So we’ll be bringing our full sales organization to bear on this program.”