Medical Device Daily
In the wake of the proposed National Coverage Decision for expanded use of carotid artery stenting (CAS), issued late last week by the Centers for Medicare & Medicaid Services, several companies involved in the space expressed their excitement at the prospect of the increased patient pool treated with these devices, and they hope to see an even broader patient population put into play.
Under Medicare's current policy, patients with no symptoms of narrowing of the arteries but considered high risk for undergoing a carotid endarterectomy (CEA) procedure, are only covered when CAS procedures are performed in FDA Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies or in accordance with the Medicare clinical trial policy (Medical Device Daily, Feb. 5, 2007).
Medicare is proposing to expand coverage for CAS to this group of patients who have greater than 80% carotid artery stenosis.
Several medical device makers have U.S. regulatory approval for carotid stenting, including Abbott Laboratories (Abbott Park, Illinois), Boston Scientific (Natick, Massachusetts), Johnson & Johnson (New Brunswick, New Jersey), ev3 (Plymouth, Minnesota) and C.R. Bard (Murray Hill, New Jersey).
Carotid stents are inserted via a small puncture in the groin and threaded through the blood vessels and up into the carotid artery in the neck. The goal is to clear the arteries of fat deposits that clog those vessels and can break off, drift to the brain and cause strokes.
Abbott, which touts itself as the market leader in the CAS market with two carotid stents, Xact and Acculink, said it played an instrumental part in securing the proposed expanded coverage decision. It made a formal request to CMS to revise the coverage decision and provided the agency with the data on which to make the expansion decision.
"Abbott is pleased that CMS is considering expanded reimbursement coverage for patients with carotid artery disease who are at high risk for surgery and who do not exhibit symptoms of stroke," it said in a statement.
Abbott said it believes the impact of this decision represents a significant, positive impact — 50%-75% market growth; $50 million to $75 million on an annual basis.
The carotid stent market is currently valued at about $100 million in the U.S.
Under the proposed policy, asymptomatic patients under age 80, who are at high risk for surgery and have 80% or greater carotid artery stenosis, would be eligible for coverage outside of a post-market study or clinical trial, as long as the procedure is performed using the FDA-approved carotid artery stent systems and embolic protection devices in a facility approved by CMS.
Medicare is also proposing to modify coverage for patients who are 80 years of age and older because of "significant concerns regarding the safety of CAS" when performed in this older patient population, in order to improve the safety of such procedures.
This proposed decision would restrict coverage of patients age 80 and above only to those CAS procedures performed in Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the clinical trial policy.
While Boston Scientific said in a statement that it supports the proposed expansion, it also noted that it supports broader coverage — meaning all patients over the age of 80, without the IDE trial qualifier recommended by CMS.
"We are excited about the opportunity for expanded coverage for carotid stenting for asymptomatic patients at high risk for surgery," said John Pedersen, president of Boston Scientific's Peripheral Interventions business. "However, we believe that clinical data from our carotid stenting trials also supports expansion of coverage for high-risk symptomatic patients" — that is for those previously considered unable to withstand the surgery.
Pedersen noted that the CMS proposal comes on the heels of Boston Scientific's launch of the NexStent carotid stent and the FilterWire EZ embolic protection system, "two products that utilize state-of-the art technology to address the need for stroke protection in high-surgical risk patients with carotid artery stenosis. We look forward to continuing to provide CMS with data to support even broader coverage of carotid stenting."
The NexStent, developed by EndoTex Interventional Systems (Cupertino, California) — which Boston Scientific acquired last month — was FDA-approved in November (MDD, Nov. 7, 2006) and was studied in the CABERNET trial along with the Boston Scientific FilterWire EZ embolic protection system that received an FDA clearance for use in CAS in December (MDD, Dec. 15, 2006).
CMS said there will be a public comment period, with a final decision on the coverage expansion expected May 3.